Transcript Exploratory Outcome Study of Ibogaine Therapy in Subjects

Exploratory Outcome Study of
Ibogaine Therapy in 20
Subjects with Opiate Addiction
Valerie Mojeiko
Multidisciplinary Association for
Psychedelic Studies (MAPS)
www.maps.org
Agenda
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What is ibogaine and where is it from?
What does it do?
What is this study about?
What kind of results have we collected so
far?
Tabernanthe Iboga
Bwiti
people
Howard Lotsof
Subjective Effects
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Psychedelic that produces a dreamlike state
Review of memories
Experience lasts several days
Many find it unpleasant, not a recreational drug
Some experience psychological material related to addiction
Greatly reduces physical and psychological withdrawal
symptoms from heroin, methadone, other drugs
Neurotransmitter Activities
 Novel mechanism of action
 Complex interactions between multiple neurotransmitter
systems
 Mu-opiod agonist; NMDA antagonist; kappa opioid agonist;
serotonin 5ht2a agonist; serotonin uptake inhibitor; 5ht3 agonist;
dopamine uptake inhibitor; sigma opioid receptor agonist
Risks
 Potentiates effects of other drugs in the body
 Several deaths have been reported probably
related to ibogaine
 Myocardial infarction (heart attack), deep vein
thrombosis (blood clots), unknown causes
 Around 1% (+/- 1) death rate suggested
 Appears to be much more dangerous than
any other psychedelic
Existing treatment facilities providing detoxification--not
collecting information…
 How well does it work? How safe is it?
 What percentage of people benefit and
to what degree?
 How can these treatments be
improved?
 Should formal studies be conducted?
MAPS’ Role: Evaluating program, providing feedback, and
collecting data for research
Preliminary Data: June 2004: Iboga
Therapy House: 2wks-1yr after tx
(avg. 6 months)
 20 subjects
 6 of 7 treated for
Cocaine/Crack
abstinent (86%)
 3 of 8 treated for
opiates abstinent
(38%)
 4/5 treated for other
substances
abstinent (80%)
6
5
4
Abstinent
Using
3
2
1
0
CO C
Al coh ol
Me th
How?
 This is an exploratory study to get preliminary
basic data--NOT a controlled study, but it is
representative since we’re including 20
Subjects treated consecutively at a treatment
center
 One-year series of questionnaires and
interviews from 20 subjects verified by
interview with significant others
 Harm reduction model: looking at abstinence
as well as non-abstinence outcomes, trying to
differentiate between abuse and controlled
use
Measures
 Addiction Severity Index (primary variable)
 Beck Depression and Anxiety Inventories
 Subjective and Objective Opiate Withdrawal
Scales (SOWS/OOWS)
 Visual Analogue Scale Pain Measure
 Peak Experience Profile
 Supplemental Surveys
Schedule for Outcome Measures
i
ASI
P W 1 2 3 4 5 6 7 8 9 1 1 1
2
0 1 2
X
X X X X X X X X X X X X
BDI/BAI
X
PEP
X X X X X X X X X X X X X
X
O/SOWS X X X
Pain
Surveys
SO
check
X X X X X X X X X X X X X X X
X X X X X X X X X X X X X X
X X X X X X X X X X X X X X X
i=Intake; P=Post-treatment; W2=Week 2; 1-12=Months 1-12
ASI-Addiction Severity Index
 Semi-structured 1 hour interview
 Scores on 7 subscales: medical status,
employment and support, drug use,
alcohol use, legal status, family/social
status, and psychiatric status
 Been used extensively on a wide variety
of outcome studies
Peak Experience Profile (PEP)
 180 items; one composite score; 16
subscores
 Developed in the 60s for Walter Pahnke’s
Good Friday experiment
 Used in LSD/Psilocybin studies with
alcoholics, heroin addicts, and cancer
patients with anxiety
 Expanded later by Francesco Di Leo to
include nadirs as well as peaks for a study on
LSD and cancer
 Di Leo hypothesized that people who had
high scores on both peak and nadir would
have greater benefit (unfinished)
Challenges
 No drug testing
 Difficulty of remaining in contact during
follow-up
 Check-in with significant other
addresses these concerns
So Far…
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Five Subjects have enrolled in study
1 has maintained abstinence from opiates
4 have gone back to opiate use
2 dropped out of study early
Subject 1001
 36 year old male
 Problem substance: Methadone 38/mg/day
 2 weeks after tx, client decided to resume
methadone maintenance at 19 mg/daily
 Proceeded to taper down
 By M8/V12 was abstinent again
Baseline= 1.8879
Avg post-treatment=1.1462
Decrease=.7417
Subject 1001
Subject 1002
 54 yr old male
 Problem substance: Heroin 2.5/g/day
 Has achieved complete abstinence,
currently at V15
Baseline Score=1.1631
Avg score post-treatment=.423525
Decrease=.739575
Subject 1003
 25 yr old female
 Problem substance: binge heroin use,
prescribed methadone 20mg/day, self
prescribed hydrocodone 20-300 mg/day,
oxycodone 240 mg/day
 M1/V6 reported relapse at 40mg oxy/day
 Increased opiate use, began methadone
again
Baseline score=1.3353
Average score post-treatment=1.3540
Increase=.0187
Remove outlier, decrease=.17268
Subject 1004
 51 yr old male
 Problem substance oxycodone 160-200
mg/day
 Car accident on way home from airport,
restarted oxycodone (20mg/day) to aid pain
related to accident
 Chose not to complete study
Subject 1005
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25 yr old male
Problem substance: heroin 1g/day
Reported relapse 1-2 weeks after treatment
Chose not to complete study
Goals
 Obtain basic information about
outcomes in underground clinics
 How well does it work and under what
conditions does it work best?
 Does it work best in some subset of
subjects more so than in others?
 Ideally lead to placebo-controlled
double-blind studies, or not
Conclusion
 Ibogaine is an unusual psychedelic
 For addiction: works for some people,
doesn’t work for others
 Don’t have a large enough sample yet
to know what is different about people
for whom it works