Exploratory Outcome Study of Ibogaine Therapy in 20 Subjects with Opiate Addiction

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Exploratory Outcome Study of Ibogaine Therapy in
20 Subjects with Opiate Addiction

• Valerie Mojeiko
• Multidisciplinary Association for Psychedelic
  Studies (MAPS) www.maps.org

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Agenda

• 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?

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Tabernanthe Iboga
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Bwiti people
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Howard Lotsof
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Subjective 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

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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

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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

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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
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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)

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How?

• 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

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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

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Schedule for Outcome Measures
iIntake PPost-treatment W2Week 2
1-12Months 1-12
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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

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Peak 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)

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Challenges

• No drug testing
• Difficulty of remaining in contact during
  follow-up
• Check-in with significant other addresses these
  concerns

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So 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

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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

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Baseline 1.8879Avg post-treatment1.1462Decreas
e.7417
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Subject 1001
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Subject 1002

• 54 yr old male
• Problem substance Heroin 2.5/g/day
• Has achieved complete abstinence, currently at V15

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• Baseline Score1.1631
• Avg score post-treatment.423525
• Decrease.739575

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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

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• Baseline score1.3353
• Average score post-treatment1.3540
• Increase.0187
• Remove outlier, decrease.17268

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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

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Subject 1005

• 25 yr old male
• Problem substance heroin 1g/day
• Reported relapse 1-2 weeks after treatment
• Chose not to complete study

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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

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Conclusion

• 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