Significance of “Unofficial” Ibogaine Treatment Scenes

• The existence of these scenes indicates demand for alternatives to existing treatment options.

• Averse events including fatalities indicate the need for appropriate prospective medical evaluation of patients, monitoring within the treatment, and reliable formulations of ibogaine.

• “Anecdotal” or “case report” evidence suggests a possible neurobiological drug action.

• All of the above strongly support the need for appropriate clinical trials to evaluate safety and efficacy in order to gain official approval

US and European Ibogaine Scenes Through the Year 2000

Scene, yr.began-

N Indication Dose Comments

US, New YorkCity, 1962-63

20 Psychologicalinsight, self-experimentation

6-19 mg/kg Initial cohort on whom H.Lotsof’s observation of putativeeffect on opioid withdrawal wasmade1,2,3

Netherlands,1989-93

~40-45 Addiction,mainly opioidsand cocaine

15-29 mg/kg Treatments arranged by H.Lotsof and Dutch and U.S. addictself-help groups1,2,3,4

St. Kitts, WestIndies 1996-

~150 asof 2000

Addiction,mainly opioidsand cocaine

600-1200 mg Medical model including MDsupervised pretreatmentevaluation and monitoring1,5

U.S. WestCoast 1950s-?

? Psychologicalinsight

150-300 mg Highly secretive scene involvingsignificant involvement ofcredentialed healthprofessionals1,6

Eric Taub1992-

~310 asof 2000

Psychologicalinsight,addiction

(mg/kg)Insight: 9-12;Addiction:cocaine, 12-18, heroin,20-24

Majority of treatments forindication of psychologicalinsight, conducted in Caribbeanin informal setting1

Netherlands1999-

22addicts,4 non-addicts

Addiction(heroin,cocainealcohol),psychologicalinsight

3 to 6 gextract (unk.% ibogaine),sometimeswith 3-500 mgibogaine

Individual providing treatmentsin setting of her own home1

Slovenia 1995- ~150 asof 2000

Addiction,psychologicalinsight

? Loosely organized; the IbogaFoundation in Ljubljana providesinformation and assists inarranging treatments1,7

U.K. 1998- ~1/weekas of2000

Addiction,psychologicalinsight

? Very loosely organized, ibogaineavailable via internet or certainsmall retail shops1

Italy 1994- 35-40 Addiction,psychologicalinsight

? Small scene involving a singleindividual working with his ownextract from iboga root bark1

Czech Republic2000-2001

~60 non-addicts,18addicts

psychologicalinsight,addiction(heroin)

(mg/kg)Insight,13-18;Addiction, 20-22

Treatment provider discontinuedactivity after approximately oneyear due to perception of limitedbenefit w/o systematic aftercare1

1. Alper, K.R., Beal D., and Kaplan C.D. (2001). A Contemporary History of Ibogaine in the United States and Europe. In Ibogaine: Proceedings of the First International Conference (The Alkaloids Volume 56), pp. 249-281. Academic Press, San Diego, California.

2. Lotsof, H.S., and Alexander N.E. (2001). Case studies of ibogaine treatment: implications for patient management strategies. In Ibogaine: Proceedings of the First International Conference (The Alkaloids Volume 56), pp. 293-313. Academic Press, San Diego, California.

3. Alper, KR, Lotsof, HS, Frenken, GMN, Luciano, DJ, and Bastiaans, J. Treatment of Acute Opioid Withdrawal with Ibogaine. American Journal on Addictions 8: 234-242, 1999.

4. Frenken G. (2001). From the roots up: ibogaine and addict self-help. In Ibogaine: Proceedings of the First International Conference (The Alkaloids Volume 56), pp. 283-292, Academic Press, San Diego, California.

5. Mash, D.C., Kovera A. , Pablo J., Tyndale R., Ervin F.R., Kamlet J.D., and Hearn W.L. (2001). “Ibogaine in the Treatment of Heroin Withdrawal” Ibogaine: Proceedings of the First International Conference (The Alkaloids Volume 56), (K. Alper and S.D. Glick Eds.), pp. 155-171. Academic Press, San Diego, California.

6. Stolarof MJ. The Secret Chief. (1997) Multidisciplinary Association for Psychedelic Studies, Charlotte NC, 144 pages.

7. Kastelic , A. “Self-Help Use of ibogaine in Slovenia” Presented at the First International Conference on Ibogaine. New York, NY, Nov. 5 1999.

Reports of Ibogaine Treatment in Humans

• Case studies presented to NIDA in March 1995; 41 individuals receiving a total of 52 treatments

• Published case reports (high degree of overlap with the above) describing a total of 56 treatments

• Open label prospective study N=32 (Mash et al.)

Published Ibogaine Case Studies

• One paper describing 33 treatments for opioid dependence; complete resolution of withdrawal signs and absence of drug-seeking behavior in 25 (76%)1.

• Total of 13 treatments, mainly for opioid dependence, in four additional papers2,3,4,5.

1. Alper, KR, Lotsof, HS, Frenken, GMN, Luciano, DJ, and Bastiaans, J (1999). Treatment of Acute Opioid Withdrawal with Ibogaine. American Journal on Addictions 8: 234-242.2. Cantor, M. (1990). ``Interviews: ibogaine treated addicts''. The Truth Seeker 117(5), 23-26. 3. Luciano, DJ. (1998). Observations on treatment with Ibogaine. American Journal on Addictions 7, 89-90.4. Sheppard, S.G. (1994). A preliminary investigation of ibogaine: case reports and recommendations for further study. J.Subst.Abuse Treat. 11, 379-385.5. Sisko, B. (1993). Interrupting drug dependency with ibogaine: a summary four case histories. Multidisciplinary Association For Psychedelic Studies (MAPS) Newsletter 4: 15-24.

Drug Abstinence Following Ibogaine Treatment (unpublished, presented to

NIDA March 1995)

Reported Time Interval of Post-treatment Drug Abstinence N (%)

<2 months 15 (29%)

2 to <6 months 15 (29%)

6 months to <1 year 7 (13%)

≥ 1 year 10 (19%)

Not determined 5 (10%)

Alper, K.R. (2001). Ibogaine: A Review. In Ibogaine: Proceedings of the First International Conference (The Alkaloids Volume 56), (K. R. Alper and S.D. Glick, Eds.), pp. 1-38. Academic Press, San Diego, California.

Table 1 from: Alper, KR, Lotsof, HS, Frenken, GMN, Luciano, DJ, and Bastiaans, J. Treatment of Acute Opioid Withdrawal with Ibogaine. American Journal on Addictions 8: 234-242, 1999.

Retrospective Case Series From Early1960’s U.S. and Late 1980’s-Early 1990’s Dutch Informal Scenes:

Subjects

Table 2 from: Alper, KR, Lotsof, HS, Frenken, GMN, Luciano, DJ, and Bastiaans, J. Treatment of Acute Opioid Withdrawal with Ibogaine. American Journal on Addictions 8: 234-242, 1999.

Retrospective Case Series From Early1960’s U.S. and Late 1980’s-Early 1990’s Dutch Informal Scenes:

Outcomes

Prospective Open Label Study (Mash et al. 2001) 1

• 32 patients treated for opioid (heroin or methadone) withdrawal.• Withdrawal Symptoms measured using the Objective Opiate Withdrawal Scale (OOWS)• Fixed dose of 800 mg ibogaine HCl given approximately 12 hours after the last opiate dose• OOWS significantly reduced at 12 and 24 hours post ibogaine administration; the level of

discomfort at these acute relative to post-treatment time points was as low as the level seen 1 week later. Objective signs of opiate withdrawal rarely seen and none increased at later time points.

• Decreased craving at <72 hours post-treatment; these reductions were maintained at 6 to 9 days post-treatment

• Depression scores reduced relative to pre-treatment at 6 to 9 days and 1 month post-treatment

1. Mash, D.C., Kovera A. , Pablo J., Tyndale R., Ervin F.R., Kamlet J.D., and Hearn W.L. (2001). “Ibogaine in the Treatment of Heroin Withdrawal” in Ibogaine: Proceedings of the First International Conference (The Alkaloids Volume 56), (K. Alper and S.D. Glick Eds.), pp. 155-171. Academic Press, San Diego, California.

Disease-Specific Advocacy

Examples of Disease Specific Advocacy

• HIV: Aids Coalition to Unleash Power (ACT UP); Treatment Action Group (TAG)

• Opiate Dependence: Dutch Junkiebond, Danish Drug Users Union

• Psychiatric Disorders: National Alliance for the Mentally Ill (NAMI)

Nico Adriaansorganizer

Dutch Addict Self-Help

Political Advocacy Graphics