Exploratory Outcome Study of Ibogaine Therapy in 20

Subjects with Opiate Addiction

Exploratory Outcome Study of Ibogaine Therapy in 20

Subjects with Opiate Addiction

Valerie MojeikoMultidisciplinary Association for

Psychedelic Studies (MAPS) www.maps.org

Valerie MojeikoMultidisciplinary Association for

Psychedelic Studies (MAPS) www.maps.org

AgendaAgenda

What is ibogaine and where is it from? What does it do? What is this study about? What kind of results have we collected so

far?

What is ibogaine and where is it from? What does it do? What is this study about? What kind of results have we collected so

far?

Tabernanthe Iboga

Bwiti people

Howard Lotsof

Subjective EffectsSubjective Effects

Psychedelic that produces a dreamlike state Review of memories Experience lasts several days Many find it unpleasant, not a recreational drug Some experience psychological material related to addiction Greatly reduces physical and psychological withdrawal

symptoms from heroin, methadone, other drugs

Psychedelic that produces a dreamlike state Review of memories Experience lasts several days Many find it unpleasant, not a recreational drug Some experience psychological material related to addiction Greatly reduces physical and psychological withdrawal

symptoms from heroin, methadone, other drugs

Neurotransmitter ActivitiesNeurotransmitter Activities

Novel mechanism of action Complex interactions between multiple neurotransmitter

systems Mu-opiod agonist; NMDA antagonist; kappa opioid agonist;

serotonin 5ht2a agonist; serotonin uptake inhibitor; 5ht3 agonist; dopamine uptake inhibitor; sigma opioid receptor agonist

Novel mechanism of action Complex interactions between multiple neurotransmitter

systems Mu-opiod agonist; NMDA antagonist; kappa opioid agonist;

serotonin 5ht2a agonist; serotonin uptake inhibitor; 5ht3 agonist; dopamine uptake inhibitor; sigma opioid receptor agonist

RisksRisks Potentiates effects of other drugs in the body Several deaths have been reported probably

related to ibogaine Myocardial infarction (heart attack), deep vein

thrombosis (blood clots), unknown causes Around 1% (+/- 1) death rate suggested

Appears to be much more dangerous than any other psychedelic

Potentiates effects of other drugs in the body Several deaths have been reported probably

related to ibogaine Myocardial infarction (heart attack), deep vein

thrombosis (blood clots), unknown causes Around 1% (+/- 1) death rate suggested

Appears to be much more dangerous than any other psychedelic

Existing treatment facilities providing detoxification--not collecting information…

Existing treatment facilities providing detoxification--not collecting information…

How well does it work? How safe is it? What percentage of people benefit and

to what degree? How can these treatments be

improved? Should formal studies be conducted?

How well does it work? How safe is it? What percentage of people benefit and

to what degree? How can these treatments be

improved? Should formal studies be conducted?

MAPS’ Role: Evaluating program, providing feedback, and collecting data for research

Preliminary Data: June 2004: Iboga Therapy House: 2wks-1yr after tx

(avg. 6 months)

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%)

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 Alcohol Meth

AbstinentUsing

0

1

2

3

4

5

6

COC Alcohol Meth

AbstinentUsing

How?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

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

MeasuresMeasures

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

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 X

BDI/BAI X X X X X X X X X X X X X X

PEP X

O/SOWS X X X

Pain X X X X X X X X X X X X X X X

Surveys X X X X X X X X X X X X X X

SO 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 IndexASI-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

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)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)

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)

ChallengesChallenges

No drug testing Difficulty of remaining in contact during

follow-up Check-in with significant other

addresses these concerns

No drug testing Difficulty of remaining in contact during

follow-up Check-in with significant other

addresses these concerns

So Far…So Far…

Five Subjects have enrolled in study 1 has maintained abstinence from opiates 4 have gone back to opiate use 2 dropped out of study early

Five Subjects have enrolled in study 1 has maintained abstinence from opiates 4 have gone back to opiate use 2 dropped out of study early

Subject 1001Subject 1001

36 year old male Problem substance: Methadone 38/mg/day 2 weeks after tx, client decided to resume

methadone maintenance at 19 mg/daily Proceeded to taper down By M8/V12 was abstinent again

36 year old male Problem substance: Methadone 38/mg/day 2 weeks after tx, client decided to resume

methadone maintenance at 19 mg/daily Proceeded to taper down By M8/V12 was abstinent again

Baseline= 1.8879Avg post-treatment=1.1462

Decrease=.7417

Baseline= 1.8879Avg post-treatment=1.1462

Decrease=.7417

Subject 1001Subject 1001

Subject 1002Subject 1002

54 yr old male Problem substance: Heroin 2.5/g/day Has achieved complete abstinence,

currently at V15

54 yr old male Problem substance: Heroin 2.5/g/day Has achieved complete abstinence,

currently at V15

Baseline Score=1.1631Avg score post-treatment=.423525

Decrease=.739575

Baseline Score=1.1631Avg score post-treatment=.423525

Decrease=.739575

Subject 1003Subject 1003

25 yr old female Problem substance: binge heroin use,

prescribed methadone 20mg/day, self prescribed hydrocodone 20-300 mg/day, oxycodone 240 mg/day

M1/V6 reported relapse at 40mg oxy/day Increased opiate use, began methadone

again

25 yr old female Problem substance: binge heroin use,

prescribed methadone 20mg/day, self prescribed hydrocodone 20-300 mg/day, oxycodone 240 mg/day

M1/V6 reported relapse at 40mg oxy/day Increased opiate use, began methadone

again

Baseline score=1.3353Average score post-treatment=1.3540

Increase=.0187Remove outlier, decrease=.17268

Baseline score=1.3353Average score post-treatment=1.3540

Increase=.0187Remove outlier, decrease=.17268

Subject 1004Subject 1004

51 yr old male Problem substance oxycodone 160-200

mg/day Car accident on way home from airport,

restarted oxycodone (20mg/day) to aid pain related to accident

Chose not to complete study

51 yr old male Problem substance oxycodone 160-200

mg/day Car accident on way home from airport,

restarted oxycodone (20mg/day) to aid pain related to accident

Chose not to complete study

Subject 1005Subject 1005

25 yr old male Problem substance: heroin 1g/day Reported relapse 1-2 weeks after treatment Chose not to complete study

25 yr old male Problem substance: heroin 1g/day Reported relapse 1-2 weeks after treatment Chose not to complete study

GoalsGoals

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, or not

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, or not

ConclusionConclusion

Ibogaine is an unusual psychedelic For addiction: works for some people,

doesn’t work for others Don’t have a large enough sample yet

to know what is different about people for whom it works

Ibogaine is an unusual psychedelic For addiction: works for some people,

doesn’t work for others Don’t have a large enough sample yet

to know what is different about people for whom it works