Title: Exploratory%20Outcome%20Study%20of%20Ibogaine%20Therapy%20in%2020%20Subjects%20with%20Opiate%20Addiction
1Exploratory Outcome Study of Ibogaine Therapy in
20 Subjects with Opiate Addiction
- Valerie Mojeiko
- Multidisciplinary Association for Psychedelic
Studies (MAPS) www.maps.org
2Agenda
- 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?
3Tabernanthe Iboga
4Bwiti people
5Howard Lotsof
6Subjective Effects
- 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
7Neurotransmitter 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
8Risks
- 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
9Existing 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
10Preliminary 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)
11How?
- This is an exploratory study to get preliminary
basic data--NOT a controlled study, but it is
representative since were 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
12Measures
- 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
13Schedule for Outcome Measures
i P W2 1 2 3 4 5 6 7 8 9 10 11 12
ASI X X X X X X X X X X X X X
BDI/BAI X X X X X X X X X X X X X X
PEP X
O/SOWS X X X
Pain X X X X X X X X X X X X X X X
Surveys X X X X X X X X X X X X X X
SO check X X X X X X X X X X X X X X X
iIntake PPost-treatment W2Week 2
1-12Months 1-12
14ASI-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
15Peak Experience Profile (PEP)
- 180 items one composite score 16 subscores
- Developed in the 60s for Walter Pahnkes 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)
16Challenges
- No drug testing
- Difficulty of remaining in contact during
follow-up - Check-in with significant other addresses these
concerns
17So Far
- 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
18Subject 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
19Baseline 1.8879Avg post-treatment1.1462Decreas
e.7417
20Subject 1001
21Subject 1002
- 54 yr old male
- Problem substance Heroin 2.5/g/day
- Has achieved complete abstinence, currently at V15
22- Baseline Score1.1631
- Avg score post-treatment.423525
- Decrease.739575
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24Subject 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
25- Baseline score1.3353
- Average score post-treatment1.3540
- Increase.0187
- Remove outlier, decrease.17268
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27Subject 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
28Subject 1005
- 25 yr old male
- Problem substance heroin 1g/day
- Reported relapse 1-2 weeks after treatment
- Chose not to complete study
29Goals
- 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
30Conclusion
- Ibogaine is an unusual psychedelic
- For addiction works for some people, doesnt
work for others - Dont have a large enough sample yet to know what
is different about people for whom it works