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Exploratory Outcome Study of Ibogaine Therapy in 20 Subjects with Substance Addiction Valerie Mojeiko Multidisciplinary Association for Psychedelic Studies (MAPS) www.maps.org 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%) 6 5 4 Abstinent Using 3 2 1 0 COC Opiate Alcohol Pot Meth Comb. 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 Process • All interviews are conducted by aftercare coordinator • Interviews conducted in person and by phone • Each interview takes about an hour • Valerie organizes and analyzes data 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 Schedule for Outcome Measures ASI BDI/BAI PEP O/SOWS Pain Surveys SO check i P W1 2 X X X X X X X X X X X X X X X X X X X X 2 3 4 5 6 7 8 9 1 0 X X X X X X X X X X X X X X X X X X 1 1 X X 1 2 X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X 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 at Ibogaine Association • December-ASI training • Iboga Therapy House & Ibogaine Association shut down • Interest from more clinics to participate in study • Partial funding obtained from John Gilmore, seeking about $15,000 more www.maps.org/donate 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