Transcript Implementing Substitution Treatment

as HIV prevention among
IDUs: Developing countries
WORKSHOP
Monday, 23 July, 2012
Let’s try to know each other…
 I am…
Dr. Atul Ambekar (MD, Psychiatry)
Associate Professor
National Drug Dependence Treatment Centre, AIIMS, New Delhi
Member: Reference group to UN on HIV and IDU
Contents
OST: The
context and
basics
Practice
Guidelines:
Buprenorphine
Practice
Guidelines:
Methadone
Operational
Issues
Contents
OST: The
context and
basics
Practice
Guidelines:
Buprenorphine
Practice
Guidelines:
Methadone
Operational
Issues
Terminology
Part 1: OST
What’s in a name?
Agonist maintenance treatment
Agonist substitution treatment
Oral maintenance treatment
Oral substitution treatment (OST)
Buprenorphine / Methadone maintenance
treatment
 Buprenorphine / Methadone substitution
treatment
 Medication Assisted Treatment (MAT)





Part 1: OST
Opioids
Part 1: OST
Opiate / Opioid : What’s the
Difference?
Opiate
 A term that refers
to drugs or
medications that
are derived from
the opium poppy,
such as heroin,
morphine,
codeine.
Part 1: OST
Opioid
 A more general term that
includes opiates as well as
the synthetic drugs or
medications, such as
buprenorphine, methadone,
meperidine, pentazocine —
that produce analgesia and
other effects similar to
morphine.
Opium
Part 1: OST
Heroin (Smack)
Street Names:
Brown Sugar
Part 1: OST
White Sugar
Heroin: ‘chased’ or injected
Part 1: OST
What’s What?
Agonists, Partial Agonists,
and Antagonists
Agonist
Partial Agonist
Antagonist
Part 1: OST
Morphine-like effect (e.g., heroin)
Maximum effect is less than a full
agonist (e.g., buprenorphine)
No effect in absence of an opiate or
opiate dependence (e.g., naloxone,
naltrexone)
Understanding ‘agonists’
Part 1: OST
Opioid Agonists
Site of action of
Opioids
Part 1: OST
Opioid Agonists
Opium
(morphine)
Part 1: OST
Opioid Agonists
Heroin
Part 1: OST
Opioid Agonists
Buprenorphine
Part 1: OST
NALTREXONE
Part 1: OST
Opioid
Antagonists
Opioid
Antagonists
Opium
NALTREXONE
Part 1: OST
Heroin
Buprenorphine
 Natural derivatives
Opioid
of opium poppy
- Opium
 Semisynthetics:
- Morphine
Derived from
- Codeine
chemicals in opium
Agonists
-Diacetylmorphine –
Heroin
- Hydromorphone
 Synthetics
- Oxycodone
 Propoxyphene
 Methadone
 Levo-alphaacetylmethadol
 Buprenorphine
 Pentazocine
Part 1: OST
 Natural derivatives
Opioid
of opium poppy
- Opium
 Semisynthetics:
- Morphine
Derived from
- Codeine
chemicals in opium
Agonists
-Diacetylmorphine –
Heroin
- Hydromorphone
 Synthetics
- Oxycodone
 Propoxyphene
 Methadone
 Levo-alphaacetylmethadol
 Buprenorphine
CAN BE / ARE INJECTED
 Pentazocine
Part 1: OST
Opioids: Acute effects
Psychological effects
The effects differ widely between new and chronic
(dependent) users
 New users
 who is not in pain 
an unpleasant
reaction.
 Who has pain or
anxiety  some
relief
Part 1: OST
 Dependent users
 short lived in-tense
experience – “rush”.
 A state of profound
euphoria.
 a dreamlike state
lasting longer
Opioid Withdrawal Syndrome
Acute Symptoms
HOURS to DAYS
 Opening of all holes !
 Pupillary dilation
 Lacrimation (watery eyes)
 Rhinorrhea (runny nose)
 Yawning, sweating, chills, gooseflesh
 Stomach cramps, diarrhea, vomiting
 Aches and Pains, Muscle spasms (“kicking”)
 Restlessness, anxiety, irritability
Part 1: OST
Opioid Withdrawal Syndrome
Opioid
Withdrawal
Protracted withdrawals
Syndrome
WEEKS to MONTHS
Protracted Symptoms
 Deep muscle aches and pains
 Insomnia, disturbed sleep
 Poor appetite
 Premature ejaculation, Reduced libido,
impotence, anorgasmia
 Depressed mood, anhedonia
 Drug craving
Part 1: OST
Treatment of opioid dependence
 Drug Dependence is
a chronic, relapsing
disorder
 Should be seen as a
‘chronic noncommunicable
disease’
Part 1: OST
Treatment of opioid dependence
Part 1: OST
Detoxification
 Treatment of withdrawal symptoms
 Short-term
 Associated with very high rates of
relapse
…hence the need of long-term
treatment…
Part 1: OST
Philosophy of Agonist Substitution
Drugs of abuse: (e.g.
Heroin)
• An illicit,
• medically
unsafe, shortacting, more
addictive Opioid,
• Taken by
injecting route…
Part 1: OST
Agonist medications: (e.g.
Buprenorphine)
Is substituted with…
• …legal, safer,
long-acting
agonist
medication of
known purity
and potency
along with
psychosocial
rehabilitation
What kind of medications are suitable for
agonist maintenance?
 Ability to control withdrawal symptoms
 Should reduce desire to take illicit drugs
 Minimum side-effects
 Easy to administer
 Low euphoria – low dependence potential
 Economical, Easily available
 Long acting (so that frequent dosing is not
required)
Part 1: OST
Medications suitable for agonist
maintenance
 Methadone
 Buprenorphine
 LAAM
 Slow-Release Oral Morphine
 ? opium
Part 1: OST
Comparing OST and Heroin
BUPRENORPHINE
HEROIN
Orally (sublingually) effective. Not orally effective. Injecting
is a risk factor for
No risk of infection.
transmission of infectious
diseases.
Chasing route has a risk of
respiratory illnesses.
Long-acting. Administered
Short-acting. Must be
once a day.
administered several times a
day.
Causes minimal sedation or
euphoria.
Part 1: OST
Can cause significant sedation
and/or euphoria.
Heroin vs. OST
INTOXICATION
Opiate
Effect
WITHDRAWAL
 Time 
Part 1: OST
Effectiveness of OST
Reduces drug
consumption,
promotes
abstinence
Reduces risky
behaviors, risk of
HIV transmission
Reduction in
crime
Benefits
Reductions in
sex work
Part 1: OST
Reductions in
lethal overdose
Why is OST relevant for HIV
associated with IDU?
 IDU: Known risk factor of HIV
 In some countries, MAJOR route of
transmission
 Vulnerable for EXPLOSIVE epidemics of
HIV
 Can affect even the bridge populations
through sexual networks
 Opioids are the drugs preferred by IDUs
in many countries
Part 1: OST
DRUG USE AND HIV/AIDS
Wives and
girlfriends of
clients
Clients
of FSWs
Wives and girlfriends of
Substance users
Female Sex
Workers
Generalized HIV
epidemic
IDUs
Husbands and
boyfriends of FSWs
RISK RINGS
HIV
Substance Users
35
OST: current global status
 Both Buprenorphine and Methadone
Approved by US FDA
Endorsed by the UN system
Listed as ‘essential medications’ by WHO
Are being used in a number of countries
Part 1: OST
OST: current global status
Part 1: OST
OST: current global status
Part 1: OST
Myths about substitution treatment
Part 1: OST
MYTH #1: Patients are still
addicted
FACT: It is true that a person on OST upon
missing a dose will experience Withdrawl
symptoms. However concept of Addiction
or Dependence Syndrom is much broader.
 Physical dependence on a medication for
treatment of a medical problem does not
mean the person is engaging in
pathologic use and other behaviors.
Part 1: OST
MYTH #2: OST is simply a
substitute for illegal drugs
FACT: Buprenorphine / Methadone are
replacement medications; not simply a
substitute
 legally prescribed medications, not
illegally obtained.
 Medication taken through safe route of
administration.
 OST allows the person to function
normally.
Part 1: OST
MYTH #3: Providing medication
alone is sufficient treatment for
opioid addiction
FACT: OST Medication is an important
treatment option. However, the
complete treatment package must
include other elements, as well.
 Combining pharmacotherapy with counseling
and other ancillary services increases the
likelihood of success.
Part 1: OST
Myth # 4: OST is a “cure”
for addiction
FACT
It is not a cure
It is a treatment modality that helps in
repairing the damage caused by opioid
dependence
Part 1: OST
Contents
OST: The
context and
basics
Practice
Guidelines:
Methadone
Practice
Any
Guidelines:
Questions
?
Buprenorphine
Operational
Issues
Contents
OST: The
context and
basics
Practice
Guidelines:
Buprenorphine
Practice
Guidelines:
Methadone
Operational
Issues
what is buprenorphine?
Pharmacology
Part 2: Buprenorphine
Buprenorphine
 Semi-synthetic
 25-40 times more potent than morphine
 Action:
 Partial agonist at mu receptor
 Antagonist at kappa receptor
 Can be given alternate day
Part 2: Buprenorphine
Pharmacokinetics
 Bioavailability (amount reaching blood)
 By oral route = 15 percent
 Sublingually = 51 percent
 Metabolized in liver
 Duration of action (0.3 mg):
 i.v route: lasts 3 hrs
 sublingual route: lasts 6-8 hrs
 Elimination half-life (sublingual)- 27.2 hours
Part 2: Buprenorphine
48
Implementing
Buprenorphine Substitution
Treatment
Part 2: Buprenorphine
Implementing OST:
Some Important steps …
Recruitment of clients
Assessment: (History, examination, motivation)
Discussion: (education of patient)
Informed consent
Careful monitoring
Part 2: Buprenorphine
Treatment Phases
Buprenorphine treatment can be divided
into 4 phases:




Preinduction
Induction
Maintenance
Discontinuation
Part 2: Buprenorphine
Treatment Phases
Buprenorphine treatment can be divided
into 4 phases:




Preinduction
Induction
Maintenance
Discontinuation
Part 2: Buprenorphine
Preinduction
 Wait for withdrawals to appear (mild to
moderate)
 Caution for precipitated withdrawal
 Short-acting opioids (such as heroin): Patient
to abstain from 4-24 hrs
 GOAL: Minimize the risk of precipitated
withdrawal
 Precipitated withdrawal is more intense and has a
faster onset than withdrawal due to abstinence
Part 2: Buprenorphine
Treatment Phases
Buprenorphine treatment can be divided
into 4 phases:




Preinduction
Induction
Maintenance
Discontinuation
Part 2: Buprenorphine
Induction
 Goal : titrate the dose for patients to achieve
their ideal daily dose of BPN
 Ideal daily dose
 Minimize the side effects
 Minimize the drug craving
 No Intoxication
 Induction usually lasts 2 to 3 days
 Patients are kept under observation so that
dosing can be adjusted as needed
Part 2: Buprenorphine
How to start Induction?
FIRST DAY:




Patient is started on 2-4mg/day BPN on first day
Monitor the patient after 2 hours
If withdrawal symptoms persist, another 2-4mg (max 8 mg)
If patient is comfortable, review the next day
 Under-
• craving or withdrawal between doses
 Over-medicated
• buprenorphine side effects
 Properly
• neither of these experiences
medicated patients:
patients:
medicated patients:
Part 2: Buprenorphine
How to start Induction?
SECOND DAY:
 Evaluate the response to the first day's dose?
 Craving? Withdrawals? Opioid Use? Intoxication /
sedation?
 Decrease or Increase the dose accordingly
 The patient can be given an additional 2 to 4 mg of
buprenorphine until withdrawal or craving abate (max of
12 to 16 mg)
THIRD AND SUBSEQUENT DAYS:
 Many patients are already on their ideal dose
 Review the dose and adjust if required
 By and large, all patients should be stabilized by day 7
Part 2: Buprenorphine
Typical reasons for dose
increase
1) Signs and symptoms of withdrawal
2) Amount and/or frequency of opioid use not
decreasing
3) Persistent cravings for opioids
4) Failure to achieve a dose that blocks the euphoria of
short acting opioids
Part 2: Buprenorphine
Dosing overview
 Western data:
12-16mg/day maximum: 32 mg
 South Asian experience:
lower dose: ~8-10 mg/Day
Reason?
Part 2: Buprenorphine
Dosing overview
Important points to remember:
 Even small dose is helpful in alleviating
withdrawal symptoms.
 A moderate dose (4-8 mg) is useful in
reducing the craving
 A high dose (> 8 mg) may be required to
suppress the further use of heroin.
Part 2: Buprenorphine
DISPENSING
 The consumption of Buprenorphine
doses should always be supervised (i.e.
directly observed treatment - DOT).
 Prior to administering the medication, the
dispensing staff (nurse) must
 Confirm patient’s identity and patient’s current, valid
prescription
 Confirm that the patient is not intoxicated
 Conduct the necessary documentation procedures (i.e.
entering the dispensing dose in the register, getting the
signature of the patient)
Part 2: Buprenorphine
Missed doses
 If dose is missed for only one day 
continue from next day as usual
 If dose is missed for two or more days:
Assess the client
No history of other opioids used +
withdrawals present  Continue as usual
History of use of other opioids + treat like
the new case (restart)
Part 2: Buprenorphine
Missed doses
 If doses missed for three days straight:

 Find out why?
Home visit by outreach worker or
counselor
Part 2: Buprenorphine
Treatment Phases
Buprenorphine treatment can be divided
into 4 phases:




Preinduction
Induction
Maintenance
Discontinuation
Part 2: Buprenorphine
Important issues
 Frequency of
Dispensing (daily / alternate day)?
Follow-up (with doctor)?
Follow-up (with counsellor/social-worker)?
Urine testing?
Other laboratory tests?
 Co-prescription of sedative-hypnotics
Part 2: Buprenorphine
Treatment Adherence
 Important aspect of OST: treatment
adherence
 How will we know whether a client is
regularly taking treatment or not?
Regular assessment of client
Corroborating evidence
• Family members / partners (if available)
• Urine screening (if available)
Record maintenance
Part 2: Buprenorphine
Buprenorphine maintenance
When to terminate?
 Generally the treatment continues for long duration: 6
months to more than a year
 Varies from patient to patient
 Deciding criteria should be :
‘attainment of treatment goals’
 Termination should always be ‘planned’ and ‘mutual’
decision
 In-patient detoxification can be considered
 Involvement of family members
 Emphasis on continuing follow-up even after drugs stopped
 “buprenorphine has stopped; not the treatment”
Part 2: Buprenorphine
Buprenorphine: Side-Effects
Common Subjective symptoms





Generalized weakness
Euphoria
Muscle ache
Yawning
Constipation
Ray et al. 2004
Part 2: Buprenorphine
Buprenorphine: Side-Effects
Common Subjective symptoms





Generalized weakness
Euphoria
Muscle ache
Yawning
Constipation
Withdrawal, low dose
Intoxication, high dose
Withdrawal, low dose
Withdrawal, low dose
Intoxication, high dose
Ray et al. 2004
Part 2: Buprenorphine
Diversion potential: Buprenorphine
Part 2: Buprenorphine
Diversion potential: Buprenorphine
PO
SL
IV
Incorrect
Incorrect
Correct
Route
Oral
IV
Sublingual
Buprenorphine Absorbed?
NO
Yes
YES
Naloxone Absorbed?
NO
YES!!!
NO !
Outcome

Pt: 
MD: 
!
Part 2: Buprenorphine
(No Action)
Diversion potential: Buprenorphine
PO
SL
IV
Incorrect
Incorrect
Correct
Route
Oral
IV
Sublingual
Buprenorphine Absorbed?
NO
Yes
YES
Naloxone Absorbed?
NO
YES!!!
NO !
Outcome

Pt: 
Doc: 
!
Part 2: Buprenorphine
(No Action)
Diversion potential: Buprenorphine
PO
SL
IV
Incorrect
Incorrect
Correct
Route
Oral
IV
Sublingual
Buprenorphine Absorbed?
NO
Yes
YES
Naloxone Absorbed?
NO
YES!!!
NO !
Outcome

Pt: 
Doc: 
!
Part 2: Buprenorphine
(No Action)
Buprenorphine-Naloxone
combination
Buprenorphine +
Naloxone sublingual
Buprenorphine +
Naloxone sublingual
(injected)
60% bioavailability of
buprenorphine + 0%
bioavailability of naloxone
100% bioavailability of
buprenorphine + 100%
bioavailability of
naloxone
Effect of buprenorphine

Part 2: Buprenorphine
No agonist effect /
precipitation of
withdrawals

Contents
OST: The
context and
basics
Practice
Guidelines:
Buprenorphine
Practice
Guidelines:
Methadone
Any
Operational
Questions
?
Issues
Contents
OST: The
context and
basics
Practice
Guidelines:
Buprenorphine
Practice
Guidelines:
Methadone
Operational
Issues
Methadone: Induction
stabilization and
discontinuation
Part 3: Methadone
Methadone
 a synthetic full opioid agonist
 action of clinical relevance is through the muopioid receptors
 Good oral bioavailability.
 Available as
 Tablets
 Syrup (more popular)
Part 3: Methadone
Pharmacokinetics
 The time to peak plasma concentration: 4 hours
after oral administration (range 2-6 hours).
 The time to peak clinical effects: 2 – 4 hours for
first dose.
 It takes four to five days for methadone levels to
stabilise, though accumulation continues beyond
this to finally reach a steady state by ten days.
 Once a steady state is reached variations in blood
concentration levels are small.
Part 3: Methadone
Pharmacokinetics
 The length of time that methadone lasts in the body
varies depending on duration of use.
 The mean half life after single dose is 15 hrs (range
12 to 18 hours).
 For the first few days of regular use the half life
reaches about 37 hours (13 to 112 hours)
 With the optimal doses the effects usually last
between 24 to 36 hours.
Part 3: Methadone
Side effects
 A safe medication when used with usual
precautions
 No serious adverse reactions or organ damage
have been specifically associated with continued
methadone use
Part 3: Methadone
Induction
Stabilisation
Discontinuation
Part 3: Methadone
Induction
Stabilisation
Discontinuation
Part 3: Methadone
Induction
The aim of induction
 To start treatment safely and minimize the
discomfort to the patient
Part 3: Methadone
Part 3: Methadone
Part 3: Methadone
Part 3: Methadone
Part 3: Methadone
Part 3: Methadone
Part 3: Methadone
Part 3: Methadone
Part 3: Methadone
Induction Dose
Important points to remember:
The right dose varies from person to person and from
time to time
Illicit heroin varies in purity from area to area and from
time to time
The characteristics of the various medications vary: e.g.
methadone is a long acting opiate
Too much medication can be dangerous and too little is
unlikely to be effective.
Part 3: Methadone
Induction
 General guideline
START LOW AND GO SLOW
Part 3: Methadone
Induction
DAY 1
 The initial dose generally ranges between
10 and 20mg.
 If tolerance to opiates is high the dose can be
between 25 and 40mg.
 In cases where tolerance is low or uncertain, a
dose between 10 and 20mg is more appropriate.
Part 3: Methadone
Induction
DAY 1 TO 3: SAME DOSE
 as the patient will experience increasing effects from
the methadone each day
THEREAFTER: Consider dose increments of 5-10 mg
every 3 days
 The dose increments can be made at 10 mg per
week
 preferably in two divided increments of 5 mg over the
week.
 Total weekly increase should not exceed 20mg.
Part 3: Methadone
First week
 Methadone 10 to 20 mg/day X day 1 to day 3
 Methadone 25 mg/day
X day 4 to day 6
 Methadone 30 mg/day
X day 7 to day 9
 Maximum dose at the end of 1st week < 40 mg/day
 Why dose increase only after 3 days?
 The patient will experience increasing effects
from the methadone each day (accumulation)
Part 3: Methadone
Typical reasons for dose increase
1) Signs and symptoms of withdrawal
2) Amount and/or frequency of opioid use not
decreasing
3) Persistent cravings for opioids
4) Failure to achieve a dose that blocks the euphoria of
short acting opioids
Part 3: Methadone
Induction
Stabilisation
Discontinuation
Part 3: Methadone
Stablisation
 The time needed to properly stabilize someone on
methadone treatment can take up to six weeks or
more.
 Target dose for stabilization ?
 More than 60 mg/day
 Most patients likely to be comfortable around this
dose
Part 3: Methadone
Stablisation Dose
 Western studies:
 Minimum stabilization dose: 60 mg/day
 Maximum stabilization dose: 120 mg/day
 South Asian patients?
 Dose requirement likely to be lower
 Racial / genetic difference
 Difference in ‘habit size’
 Most South Asian patients should do well on 60 –
80 mg/day
Part 3: Methadone
Stablisation
 The stabilization phase can be considered to have
reached
 When the patient feels comfortable throughout 24 hours
 With no subjective or objective withdrawal before doses
 Experiences no sedation or euphoria after doses.
Should there be a need to increase or decrease the
dose after stablisation?
 Under-medicated
patients:
Over-medicated
• craving or withdrawal between doses
• Methadone side effects
patients:
Properly
medicated patients:
Part 3: Methadone
• neither of these experiences
Need to increase or decrease the dose
after stablisation
Criteria for dose increases
(once stable) can include:
Criteria for dose decreases
(once stable) can include:
Signs and symptoms of
withdrawal (objective and
subjective)
Amount and/or frequency
of opioid drug use not
decreasing
Persistent cravings for
opiates
Persistent nodding
Part 3: Methadone
Somnolence
Patients wish to reduce to
minimum effective dose
Need to increase or decrease the dose
after stablisation
Criteria for dose increases
(once stable) can include:
Criteria for dose decreases
(once stable) can include:
Signs and symptoms of
withdrawal (objective and
subjective)
Amount and/or frequency
of opioid drug use not
decreasing
Persistent cravings for
opiates
Persistent nodding
Part 3: Methadone
Somnolence
Patients wish to reduce to
minimum effective dose
DISPENSING
 The consumption of methadone doses should
always be supervised (i.e. directly observed
treatment DOT).
 Prior to administering the medication, the
dispensing staff (nurse/pharmacist) must
 Confirm patient’s identity and patient’s current,
valid prescription
 Confirm that the patient is not intoxicated
 Conduct the necessary documentation
procedures (i.e. entering the dispensing dose in
the register, getting the signature of the patient)
Part 3: Methadone
Important issues
 Frequency of





Dispensing (daily / alternate day)?
Follow-up (with doctor)?
Follow-up (with counsellor/social-worker)?
Urine testing?
Other laboratory tests?
 Co-prescription of sedative-hypnotics
Part 3: Methadone
Special issues related to Methadone
dosage
Missed Doses
Importance of missed dose?
 Patients on daily dosing become tolerant to respiratory
depression, but on missing doses there is variable and
unpredictable loss of this tolerance.
If patient loses tolerance to opioids and Methadone
is started again on the same dose..

 There is risk of respiratory depression and death
Part 3: Methadone
Special issues related to Methadone
dosage
 Missed Doses: In general the following schedule can
be presumed to be safe and effective. If the patient has missed,..
One day:
• No change in dose
Two days:
• If no evidence of intoxication
administer normal dose
Three days:
• Administer half dose in discussion
with the prescriber.
Four days:
• Recommence at 40mg or half dose
whichever is the lower
Five days or
more:
Part 3: Methadone
• regard as a new induction
Special issues related to Methadone
dosage
 Deferred Dispensing
 Patients should not receive Methadone if
they appear to be intoxicated, particularly
with alcohol;
 patients may be asked to wait to be
reassessed some hours later prior to
administration of Methadone.
Part 3: Methadone
Methadone overdose
The signs and symptoms of Methadone overdose include:
● Pinpoint pupils
● Snoring
● Nausea
● Hypotension
● Dizziness
● Slow pulse (bradycardia)
● Feeling intoxicated
● Shallow breathing
(hypoventilation)
● Frothing at the mouth
(Pulmonary Oedema)
● Coma
● Sedation/ nodding off
● Unsteady gait, slurred
speech
Part 3: Methadone
Methadone overdoses in those starting Methadone,
or in the induction phase
 Patients in the first 2 weeks who receive an overdose
of any magnitude: observation for 4 hours.
 If intoxication continues, may require referral to an
Emergency Department and use of naloxone.
 On recovery it should be followed by a more gradual
induction at lower doses.
Part 3: Methadone
Methadone and Opiate overdoses in those
well stable on Methadone
 Patients who have been on a dose >40mg/day
consistently for two months will generally
tolerate a dose double their usual dose, without
significant symptoms.
 For an overdose with greater than double the
usual daily dose the patient will require
observation for at least 4 hours.
Part 3: Methadone
Caution regarding inducing vomiting
 Inducing vomiting may be dangerous
 In circumstances where medical help is not readily
available, induction of vomiting (by mechanical
stimulation of the pharynx) within 5-10 minutes may be
appropriate as a first aid measure only.
Part 3: Methadone
Conditions warranting extra
caution for OST
 High risk poly drug use
 Concurrent use of other sedating drugs or






medications
Co-occurring alcohol dependence
Recent history of reduced opioid tolerance
Medical conditions complicating opioid use
Patients suffering with chronic pain
People with severe mental illness
Concomitant medical problems
Part 3: Methadone
Induction
Stabilisation
Discontinuation
Part 3: Methadone
Management of withdrawal from
MMT
Suggested Methadone reduction schedule
Dose
Reduction rate
Above 50 mg
5 mg per week or fortnight
30-50 mg
2.5 mg per week or fortnight
Below 30 mg
1-2 mg per week or fortnight
Part 3: Methadone
After MMT : What next?
 Possible alternatives:
 “ Drug – Free”
 Antagonist – Naltrexone
 Requires three opioid free days before
initiation
 Indian clinical experience suggest a much
better acceptance as compared to western
data
Part 3: Methadone
Cessation of Methadone
Maintenance Treatment
 Generally the treatment continues for long duration:
more than a year
 Varies from patient to patient
 Deciding criteria should be :
‘attainment of treatment goals’
 Termination should always be ‘planned’ and ‘mutual’
decision
 In-patient detoxification can be considered
 Involvement of family members
 Emphasis on continuing follow-up even after Methadone
has stopped
 “methadone has stopped; not the treatment”
Part 3: Methadone
Contents
OST: The
context and
basics
Practice
Guidelines:
Buprenorphine
Practice
Guidelines:
Methadone
Any
Operational
Issues
Questions
?
Contents
OST: The
context and
basics
Practice
Guidelines:
Buprenorphine
Practice
Guidelines:
Methadone
Operational
Issues
PSYCHOSOCIAL INTERVENTIONS
As part of OST
Part 4: Operational Issues
Part 4: Operational Issues
Part 4: Operational Issues
Part 4: Operational Issues
Part 4: Operational Issues
Psychosocial Interventions as part
of OST
Motivation Enhancement
Psycho education
Relapse Prevention
Support groups
Part 4: Operational Issues
Psychosocial Interventions as part
of OST
Motivation Enhancement
Psycho education
Relapse Prevention
Support groups
Part 4: Operational Issues
STRATEGIES/TECHNIQUES FOR ENHANCING
MOTIVATION
Feedback
Supporting
self-efficacy
Decision
balancing
Developing discrepancy
Part 4: Operational Issues
Psychosocial Interventions as part
of OST
Motivation Enhancement
Psycho education
Relapse Prevention
Support groups
Part 4: Operational Issues
PSYCHO-EDUCATION
Nature of illness:
Treatment
modality:
Treatment
duration:
Need for active
participation in
treatment:
Part 4: Operational Issues
Psychosocial Interventions as part
of OST
Motivation Enhancement
Psycho education
Relapse Prevention
Support groups
Part 4: Operational Issues
RELAPSE PREVENTION AND MANAGEMENT
Continued drug
use during
Dependence
RELAPSE
Abstinence
following
Treatment
Drug use in the
dependent pattern
LAPSE
Part 4: Operational Issues
(Single episode
of drug use)
HIGH RISK SITUATIONS
Part 4: Operational Issues
Psychosocial Interventions as part
of OST
Motivation Enhancement
Psycho education
Relapse Prevention
Support groups
Part 4: Operational Issues
SUPPORT GROUPS / SELF-HELP GROUPS
Some drug users are reluctant to enter OST
 Support Groups help to alleviate the fear and
help them to stay on the programme.
 Benefits of peer support






reduces isolation and stigma;
increases social support;
helps to share experiences;
helps people see that living without illicit drug is
possible;
reduces the workload of the health workers
Part 4: Operational Issues
Tips to make programme client-friendly
(and successful)
1. Take stakeholders into confidence
 Inform and INVOLVE them
2. Allow flexibility as much as possible
3. Involve clients – particularly in dosagedecisions
4. Open dispensary for as long as possible
5. Inform clients in advance about next holidays
 Calendar with holidays marked may help
6. Encourage treatment adherence
 Display names of regular clients prominently
Part 4: Operational Issues
Tips to make programme client-friendly
(and successful)
7. Keep replenishing the medication stocks
8. Make clear and consistent rules
 Display them prominently
9. Insist on observing discipline in the clinic
 Possible situations when treatment may be
denied / stopped on disciplinary grounds
•
•
•
Gross unruly behavior
Visit to clinic in intoxicated state
Repeated instances of diversion
Part 4: Operational Issues
Operational Issues: Developing
countries
 Demand / need of OST
 OST as stand alone vs OST integrated with other
services
 Funds / financial resources
 Infrastructure
 Human resources (Doctors, Nurses, Counselor,
Outreach staff, Managerial and support staff)
 Capacity Building
 Monitoring, Quality Assurance and Evaluation
Part 4: Operational Issues
How to choose?
Methadone Vs Buprenorphine?
 Factors which may help decide:
Clinical profile of the medication
Type of drug favored by IDUs
Cost
 Having both available enhances the
number of options
Part 4: Operational Issues
Buprenorphine: Advantages
Higher Safety Profile: Difficult to
overdose on buprenorphine alone
“Partial agonist”- a ceiling effect above
which higher doses do not increase
activity- respiratory depression unlikely
Part 4: Operational Issues
Partial vs. Full Opioid Agonist
death
Opiate
Effect
Full Agonist
(e.g., methadone)
Partial Agonist
(e.g. buprenorphine)
Antagonist
(e.g. Naloxone)
Dose of Opiate
Part 4: Operational Issues
Buprenorphine: Advantages
Sublingual medication- low activity if
swallowed, therefore safer around
children
Less euphoria
Lower Street Value:
 If used when “high” on heroin  withdrawal
 If used when in withdrawal  relief
Part 4: Operational Issues
Heroin


Heroin
Buprenorphine



How to choose?
Methadone Vs Buprenorphine?
 Factors which may help decide:
Clinical profile of the medication
Type of drug favored by IDUs
Cost
 Having both available enhances the
number of options
Part 4: Operational Issues
Models of delivery of OST: examples
OST as part of General Hospital:
• India
OST as part of targeted HIV prevention
services for IDUs:
• India
OST by Government Hospital + outreach /
psychosocial services by NGOs:
• India, Nepal
OST as part of drug treatment services:
• Bangladesh,
India,
Special settings (Mobile dispensaries,
prisons):
Part 4: Operational Issues
• India
Issues in developing countries
Part 4: Operational Issues
Issue
Limited resources
(funds)
Human resources
Dosing?
Monitoring, quality
assurance
Stakeholder
involvement
Remarks
Initiation with donor assistance
Documenting results
Advocacy for national resources
Piggyback on other national programmes
“Shared” human resources
Low cost models for capacity building
Involvement of civil society / affected groups
Lower doses required as compared to
developed countries?
Low cost local models
FAMILIES
Part 4: Operational Issues
Issue
Limited resources
(funds)
Human resources
Dosing?
Monitoring, quality
assurance
Stakeholder
involvement
Remarks
Initiation with donor assistance
Documenting results
Advocacy for national resources
Piggyback on other national programmes
“Shared” human resources
Low cost models for capacity building
Involvement of civil society / affected groups
Lower doses required as compared to
developed countries?
Low cost local models
FAMILIES
Part 4: Operational Issues
Issue
Limited resources
(funds)
Human resources
Dosing?
Monitoring, quality
assurance
Stakeholder
involvement
Remarks
Initiation with donor assistance
Documenting results
Advocacy for national resources
Piggyback on other national programmes
“Shared” human resources
Low cost models for capacity building
Involvement of civil society / affected groups
Lower doses required as compared to
developed countries?
Low cost local models
FAMILIES
Part 4: Operational Issues
Issue
Limited resources
(funds)
Human resources
Dosing?
Monitoring, quality
assurance
Stakeholder
involvement
Remarks
Initiation with donor assistance
Documenting results
Advocacy for national resources
Piggyback on other national programmes
“Shared” human resources
Low cost models for capacity building
Involvement of civil society / affected groups
Lower doses required as compared to
developed countries?
Low cost local models
FAMILIES
Part 4: Operational Issues
Issue
Limited resources
(funds)
Human resources
Dosing?
Monitoring, quality
assurance
Stakeholder
involvement
Remarks
Initiation with donor assistance
Documenting results
Advocacy for national resources
Piggyback on other national programmes
“Shared” human resources
Low cost models for capacity building
Involvement of civil society / affected groups
Lower doses required as compared to
developed countries?
Low cost local models
FAMILIES
Part 4: Operational Issues
Suggested resource material
(developing countries)
OST
Guidelines
by WHO
SEARO
Practice
Guidelines
by NACO,
India
Part 4: Operational Issues
Pharmacotherapy
Manual by
NDDTC, AIIMS
India
Opioid
Treatment
Guidelines
by WHO
Geneva
Suggested resource material
(developing countries)
 In addition practice guidelines / SOPs
exist for:
Nepal
Maldives
India
Part 4: Operational Issues
Final Discussion
Case 1

Mr. Atul is 32 year old male, married





Using Injection heroin for 4 years
Was admitted in a detox centre for 28 days, discharged only
yesterday
Currently no withdrawals
Now wants to enroll into OST programme
Can he be put on OST with



If no, why?
If yes, why? And how?
What should be the discussion points with him
Case 2

Mr. Iqbal is 28 year old man, on OST with Buprenorphine
for last 4 months






Maintained on 6 mg/day
Has shown improvement, stopped drugs
Recently started working as a laborer
Now complaining of body-ache, tiredness and difficulty in sleep
What could be the reasons?
What should you do?
Case 3






John , 28 years, on buprenorphine for 4 months (6 mg /
day)
Irregular, takes medicines about 20 days a month
Occasionally demands needles and syringes from the
NGO
Other friends suspect that he is still injecting
Should we continue OST?
Should we continue needles and syringes?
Case 4



Mr. Harish was an IDU for 7 years, was put on OST,
stopped injecting, continued OST for six months and then
dropped out
Relapsed 4 months back and has started brown sugar
smoking (but not injecting)
Is he a good candidate for OST?
Situation 5

Case A: A 38 year old man with history of opioid containing
Cough Syrup use for 5 years, followed by brown sugar
smoking for 15 years, with occasional injecting brown sugar
but no sharing
Or

Case B: A 23 year old man with history of injecting
Buprenorphine for last 2 years, with frequent sharing

If only one of them can be provided OST, which of the above
cases is more suitable for OST? And why?
100,000,000
10,000,000
100,000
50,000
10,000
Which of the following medications for OST is safest?
Methadone
Buprenorphine
Heroin
Morphine
100,000,000
10,000,000
100,000
50,000
10,000
Which of the following medications for OST is safest?
Methadone
Buprenorphine
Heroin
Morphine
100,000,000
10,000,000
100,000
50,000
10,000
Whose job it is to increase the dose of a client?
Doctor
Nurse
Outreach worker
Any one after
consulting the doctor
100,000,000
10,000,000
100,000
50,000
10,000
Whose job it is to increase the dose of a client?
Doctor
Nurse
Outreach worker
Any one after
consulting the doctor
100,000,000
10,000,000
100,000
50,000
10,000
Which of the following drug withdrawals may be dangerous
and fatal?
Buprenorphine
Inhalants
Diazepam
Heroin
100,000,000
10,000,000
100,000
50,000
10,000
Which of the following drug withdrawals may be dangerous
and fatal?
Buprenorphine
Inhalants
Diazepam
Heroin
100,000,000
10,000,000
100,000
50,000
10,000
In a stablized patient, Buprenorphine withdrawls
will start on which day?
1st Day
2nd Day
3rd Day
4th Day
100,000,000
10,000,000
100,000
50,000
10,000
In a stablized patient, Buprenorphine withdrawls
will start on which day?
1st Day
2nd Day
3rd Day
4th Day
100,000,000
10,000,000
100,000
50,000
10,000
Buprenorphine can be used for detoxification from opioids.
True
False
Only if patient is IDU
Only if patient uses heroin
100,000,000
10,000,000
100,000
50,000
10,000
Buprenorphine can be used for detoxification from opioids.
True
False
Only if patient is IDU
Only if patient uses heroin
Thank you
[email protected]
IAS/NIDA Research Fellowship Programme
Encouraging HIV and Drug Use Research
The IAS/NIDA Research Fellowship Programme is
announcing a new round of research fellowships focusing
on the linkages between HIV and drug use.
Stipend of US$ 75,000 in two categories:
 junior scientist for an 18-month post-doctoral training
 well-established HIV or drug use researcher for eight month of
professional development training
More information at www.iasociety.org/iasnida.aspx
XIX International AIDS Conference
www.aids2012.org
Special issues related to Methadone dosage
 Replacement of vomited doses
 A physician or pharmacist may replace a vomited dose
provided the vomiting was observed by a staff. The
following schedule must be followed: If the vomiting
occurred
 less than 15 minutes after ingestion: full replacement
 between 15 and 30 minutes: ½ the dose would be
replaced
 after 30 minutes: no replacement is to be given
Part 3: Methadone
SPECIAL ISSUES




Management of common side effects of
Methadone
Sleep disturbance
Non pharmacological measures such as sleep hygiene
guidance and simple relaxation techniques
long-acting benzodiazepines such as Diazepam or
Nitrazepam, in the therapeutic doses (i.e. 10 – 20 mg orally at
night)
Part 3: Methadone
Management of common side effects
of Methadone




Teeth problems
All opioids including methadone reduce the production of
saliva
Salivary flow can be increased by chewing.
Encourage patients to improve dental hygiene.
Part 3: Methadone
Management of common side
effects of Methadone



Reduced libido and sexual dysfunction: Reduced dose
may help but needs to be balanced against the risk of
return to heroin use.
Lethargy: Elucidate the cause. The methadone dose may
need to be reduced.
Constipation: Encourage patients to consume plenty of
fruits and vegetables and non alcoholic fluids each day.
Part 3: Methadone