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%)

0

1

2

3

4

5

6

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

11

12

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