Transcript Demographics: Overall

The role of counseling in the
treatment of opioid use disorders
Roger D. Weiss, MD
Harvard Medical School, Boston, MA
McLean Hospital, Belmont, MA
November 5, 2015
DATA 2000
“Physicians must attest that they
have the capacity to refer
addiction treatment patients for
appropriate counseling”
What is “appropriate counseling?”
Counseling in the context of
buprenorphine treatment
 4 of 5 studies have shown that additional
counseling is not superior to medical
management (MM) alone
 Is buprenorphine that good?
 Is MM that good?
 Is counseling that ineffective for this
population?
 Have the studies been designed properly?
 Are there subgroups of patients who
benefit from additional counseling?
Prescription Opioid Addiction
Treatment Study (POATS)
 Compared treatments for prescription opioid
dependence, using
 buprenorphine-naloxone (bup-nx) of varying
durations
 counseling of varying intensities
 Conducted as part of National Institute on
Drug Abuse Clinical Trials Network (NIDA
CTN)
 10 participating sites across the U.S.
 Largest study ever conducted for prescription
opioid dependence (N=653)
Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):1238-1246
POATS research questions
 Does adding individual drug counseling to
buprenorphine-naloxone tx + standard
medical management improve outcome?
 What length of bup-nx tx is best for
prescription opioid dependence?
 1 month vs. 3 months?
 Maintenance?
 Does current chronic pain or a history of
heroin use affect outcome?
Key eligibility criteria



DSM-IV dx of opioid dependence, not
just physical dependence
Non-psychotic, psychiatrically stable
Minimal or no heroin use
 Never dependent on heroin
 Never injected heroin
 Used heroin on <5 days in past 30
POATS main
trial design
Wei
Overview of POATS Design
 2-phase adaptive treatment research design
 Designed to approximate clinical practice
 Start with a less intensive treatment, switch to
a more intensive treatment for patients who
fail
Phase 1, up to 12 weeks
Phase 2, 24 weeks
Treatments
Wei
Buprenorphine-Naloxone
• Day 1: 4-12 mg
• Allowable dose was 8-32 mg/day
• Target dose was 16 mg/day, but flexible
dosing allowed
• Once-daily dosing recommended
• Lost prescriptions were not refilled
13
Standard Medical
Management
• Manual-based treatment
• Weekly visits with buprenorphine-certified
MD
• Initial visit: 45-60 minutes & follow-up
visits 15-20 minutes
• Assess substance use, craving, &
medication response
• Recommend abstinence & mutual-help
meetings (e.g., NA)
14
Opioid Drug Counseling
• Education about addiction & recovery
• Recommend abstinence & mutual-help
• Skills-based interactive exercises & takehome assignments
• Covers wider range of relapse prevention
issues than SMM in greater depth
 High-risk situations
 Managing emotions
 Dealing with relationships
15
Study population
Wei
Study Population
•
•
•
•
40% female
Mean age: 33 years
91% Caucasian
Extended-release oxycodone most
common drug of choice
• Relatively little other substance use
• 2/3 were in treatment for first time
• Over 60% employed
17
Baseline stratification factors
Lifetime heroin use
23%
Current chronic
pain
42%
Chronic pain definition:
Self-report of non-withdrawal pain, beyond
the usual aches & pains for >3 months
Main study results
Wei
Successful outcome, Phase 1
(N=653)
SMM + ODC
6%
SMM
7%
p
.36
Phase 1 successful outcome criteria
 ≤4 days opioid use per month
 No positive urine screens for opioids on 2 consecutive wks
 No other formal substance abuse treatment
 No injection of opioids
 No more than 1 missing urine sample during the 12 weeks
Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):1238-1246
Successful outcome, Phase 2
(n=360)
SMM +
SMM
ODC
Week 12
(end of stabilization)
52%
47%
p
.3
Phase 2 successful outcome criteria
Abstinent for ≥3 of final 4 weeks (including final week) of
bup-nx stabilization (urine-confirmed self-report)
Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):1238-1246
Phase 2: Successful outcome at
end of taper & at follow-up
SMM +
SMM Overall
ODC
p
Week 16
(end of taper)
28%
24%
26%
.4
Week 24
(8 wks post-taper)
10%
7%
9%
.2
Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):1238-1246
Lifetime heroin use as a predictor of
outcome
Heroin use
Week 12
(end of
stabilization)
Yes
No
Success
p
37%
54%
Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):1238-1246
.002
Putting the POATS counseling
findings in context
 3 other studies have found that adding
behavioral tx to bup-nx + MM doesn’t improve
outcome
 Longer MM sessions (Fiellin 2006)
 Adding CBT (Fiellin 2013)
 Adding CBT and contingency management
(Ling 2013)
One positive study for a
behavioral tx for opioid
dependence with buprenorphine
Christensen et al. (2014) (N=170, 12 weeks)
• Internet-based community-reinforcement
approach + contingency management (CM) had
better retention and 10 more abstinent days (~1
day per week) than CM alone; total continuous
abstinence not different between conditions
Key secondary analyses
in POATS
1. Do some subgroups of
patients benefit from
additional counseling?
Do subgroups benefit from
counseling?
Do subgroups of Rx opioid dependent patients
benefit from more intensive treatment, i.e.,
drug counseling in addition to bup-nx and
standard medical management?
Compared patients with
• More severe problems
• Greater attendance at treatment sessions,
i.e. adherence
• The interaction of the two
Did drug counseling improve
outcomes in more severe patients?
Illness severity operationalized as
• ASI drug composite score (mean=.34)
• Heroin use (26%)
• Chronic pain (41%)
RESULTS
Heroin users were significantly less likely to have
successful outcomes, but this was not related to being
randomized to drug counseling.
The remaining severity measures were not associated
with outcome.
Adequate attendance/adherence to
treatment
Sessions offered during 12-week Phase 2
• Medical management (360): 17
• Drug counseling (180): 18 (plus 17 MM)
Adequate adherence set a priori at ≥60% of both MM +
drug counseling sessions offered:
74% of patients met this criterion
RESULTS
Among patients with adequate attendance/adherence
(n=266), treatment assignment was not related to
outcome.
Did patients with more severe problems
have better outcomes if assigned to drug
counseling? (n=266 with adequate
adherence)
Interaction between heroin & treatment p=.03
Interpretation of results
• Heroin users were as likely to succeed
as non-heroin users if they were
randomized to drug counseling and
went (i.e., were adherent).
• Adherent heroin users assigned to SMM
alone were half as likely to succeed as all
other adherent Rx opioid patients.
2. Does early response to
buprenorphine-naloxone
predict treatment outcome
in prescription opioid
dependence?
Background and Rationale
1) Some medications, e.g., antidepressants,
may take a number of weeks to work
optimally. Therefore, waiting several weeks to
examine treatment response may be helpful.
2) We do not know the typical time course of
treatment response to buprenorphinenaloxone in the treatment of prescription
opioid dependence.
3) Knowing this could help guide clinical
practice early in the treatment of this
population.
Research questions
1) Is it possible to tell early in treatment
whether a prescription opioid dependent
patient is likely to have a successful bupnx outcome?
2) How early can bup-nx treatment response
be evaluated accurately?
Methods
Positive predictive value = the degree to
which initial opioid abstinence predicted final
successful outcome at the end of bup-nx
stabilization.
Negative predictive value = the degree to
which initial opioid use predicted final
unsuccessful outcome at the end of bup-nx
stabilization.
Predicting abstinence at end of tx
(weeks 9-12)
Week 1
Weeks 1-2
Weeks 1-3
Weeks 1-4
Initial abstinence
and final
abstinence, n
Initial abstinence
and final lack of
abstinence, n
101
88
73
68
107
70
54
45
Positive
Predictive Value,
%
49%
56
57
60
Predicting use in weeks 9-12
Initial use and final lack Initial use and final
of abstinence, n
abstinence, n
Week 1
Wks 1-2
Wks 1-3
Wks 1-4
122
89
72
58
30
6
3
2
Negative
Predictive Value,
%
80%
94
96
97
Conclusions
1) First 2 weeks of bup-nx tx are important
2) Pts who abstain from opioids in the first 2 weeks
have a reasonably good chance of abstinence at
week 12
3) However, those who use opioids in each of the
first 2 weeks (even week 1 alone) have little
chance of abstaining by week 12
4) This finding held even among pts receiving
counseling
5) Although not possible in POATS, increasing
intensity of psychosocial treatment should be
considered
Putting this together
1) Not everyone needs counseling in addition to
buprenorphine + medical management
2) Some groups of patients can benefit from
more counseling, e.g., those with prescription
opioid dependence who have used heroin
3) Not everyone wants counseling, and good
counseling is not always readily available
4) Perhaps a stepped care model should be
considered, in which those who do not do
well by week 2 increase whatever
psychosocial tx they are initially receiving
Limitations of POATS
 SMM in POATS was a more robust treatment
than is common in the U.S.
 Unclear what would have happened with
more intensive counseling and/or less
intensive SMM
Can we think of behavioral
treatments like pills?
• Active ingredients
• Filler
‘Active ingredients’ of MM
Overall health check
Self-monitoring
Checking on medication: adherence,
tolerability
Craving
Advice to abstain
Advice to attend mutual-help groups
What are the active ingredients in
counseling beyond those provided
by MM?
What should they be?
Life as a Rorschach test
Responses to POATS counseling
findings