Transcript Exploratory Outcome Study of Ibogaine Therapy in Subjects with

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