Exploratory Outcome Study of Ibogaine Therapy in 20 Subjects with Substance Addiction Valerie Mojeiko Multidisciplinary Association for Psychedelic Studies (MAPS)

Why? Drug abuse/addiction is a major health problem Underground clinics doing treatment--no records to show for it How well does it work? How safe is it? What percentage of people are they actually helping and how much? Should formal studies be conducted?

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%)

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 the Ibogaine Association 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

Process All interviews are conducted with IA aftercare coordinator Jill Stammer Interviews conducted in person and by phone Each interview takes about an hour Data is organized and analyzed by Valerie (me)

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

iPW2W 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

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

Progress End of protocol design phase/Informed Consent/Case report form Conducted trial run of 4 subjects December-ASI training Start collecting data at IA beginning of 2005 ITH shut down Interest from more clinics to participate in study Partial funding obtained from John Gilmore, seeking about $15,000 more

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