1. Exploratory Outcome Study of Ibogaine Therapy in 20 Subjects with Opiate Addiction Valerie Mojeiko Multidisciplinary Association for Psychedelic Studies (MAPS) www.maps.org Valerie Mojeiko Multidisciplinary Association for Psychedelic Studies (MAPS) www.maps.org

2. 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?  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?

3. Tabernanthe Iboga

4. Bwiti people

5. Howard Lotsof

6. 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  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

7. 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

8. 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  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

9. 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?  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

10. 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%)  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%)

11. 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  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

12. 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  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

13. iPW2W2 12345678910101 1212 ASI XXXXXXXXXXXXX BDI/BAI XXXXXXXXXXXXXX PEP X O/SOWS XXX Pain XXXXXXXXXXXXXXX Surveys XXXXXXXXXXXXXX SO check XXXXXXXXXXXXXXX Schedule for Outcome Measures i=Intake; P=Post-treatment; W2=Week 2; 1-12=Months 1-12

14. 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  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

15. 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)  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)

16. Challenges  No drug testing  Difficulty of remaining in contact during follow-up  Check-in with significant other addresses these concerns  No drug testing  Difficulty of remaining in contact during follow-up  Check-in with significant other addresses these concerns

17. 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  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

18. 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  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

19. Baseline= 1.8879 Avg post-treatment=1.1462 Decrease=.7417

20. Subject 1001

21. Subject 1002  54 yr old male  Problem substance: Heroin 2.5/g/day  Has achieved complete abstinence, currently at V15  54 yr old male  Problem substance: Heroin 2.5/g/day  Has achieved complete abstinence, currently at V15

22. Baseline Score=1.1631 Avg score post-treatment=.423525 Decrease=.739575 Baseline Score=1.1631 Avg score post-treatment=.423525 Decrease=.739575

24. 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  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 score=1.3353 Average score post-treatment=1.3540 Increase=.0187 Remove outlier, decrease=.17268 Baseline score=1.3353 Average score post-treatment=1.3540 Increase=.0187 Remove outlier, decrease=.17268

27. 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  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

28. Subject 1005  25 yr old male  Problem substance: heroin 1g/day  Reported relapse 1-2 weeks after treatment  Chose not to complete study  25 yr old male  Problem substance: heroin 1g/day  Reported relapse 1-2 weeks after treatment  Chose not to complete study

29. 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  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

30. 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  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