exploratory outcome study of ibogaine therapy in 20 subjects with substance addiction valerie...
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Exploratory Outcome Study of Ibogaine Therapy in 20
Subjects with Substance Addiction
Valerie MojeikoMultidisciplinary 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%)
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COC Opiate Alcohol Pot Meth Comb.
AbstinentUsing
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
i P W2
1 2 3 4 5 6 7 8 9 10
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ASI X X X X X X X X X X X X XBDI/BAI X X X X X X X X X X X X X XPEP XO/SOWS X X XPain X X X X X X X X X X X X X X XSurveys X X X X X X X X X X X X X XSO check
X X X X X X X X X X X X X X X
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 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