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S10

24th European Congress of Psychiatry / European Psychiatry 33S (2016) S8–S11

experiences have been funding cuts and lack of incentives. Some

examples will be presented.

Disclosure of interest

The author has not supplied his declaration

of competing interest.

http://dx.doi.org/10.1016/j.eurpsy.2016.01.797

Symposium: making medicines out of illicit

drugs – ECNP symposium hosted by EPA

JS07

Can ecstasy treat the agony of PTSD?

M. Mithoefer

Department of Psychiatry and Behavioral Sciences, Medical

University of South Carolina, Charleston, USA

Introduction

Two serotonin reuptake inhibitors (SSRIs) have

received FDA indication for treatment of PTSD, however the

effectiveness of pharmacotherapy for PTSD is limited. Psychother-

apy, including several well established evidence based methods,

is the mainstay of PTSD treatment. Despite advances in this

area, a significant percentage of PTSD patients are refractory

to existing treatments. Recent research has explored the pos-

sibility that certain drugs could increase the effectiveness of

psychotherapy when administered intermittently in conjunction

with psychotherapy sessions. The most robust published. Results

to date using this approach have been in early clinical tri-

als of

±

3,4-methylenedioxymethamphetamine (MDMA)-assisted

psychotherapy. These studies primarily involved civilians with

treatment-resistant, crime-related PTSD. A more recent phase 2

trial, completed in 2015 yielded equally promising. Results in a

cohort of military veterans, police officers and firefighters, mostly

veterans from the wars in Iraq and Afghanistan.

Methodology

In these double blind controlled trials subjects with

PTSD refractory to prior treatment are randomized to an active

dose of MDMA or an active or inactive placebo administered

to each individual on only two or three occasions during eight-

hour psychotherapy sessions one month apart, in conjunction

with preparatory and follow-up psychotherapy sessions. Outcome

measures are repeated one or two months after the secondMDMA-

assisted session before the blind is broken. Subjects who were

randomized to full dose MDMA are then eligible for one addi-

tional, open label, MDMA-assisted session. Those randomized to

placebo or a lower dose of MDMA are eligible for three open-label

full dose sessions. Outcome measures are repeated two months

following the third MDMA-assisted session. The primary out-

come measure is the Clinician Administered PTSD Scale (CAPS).

Additional measures include the Beck Depression Inventory-

II (BDI-II), Global Assessment of Functioning (GAF), Pittsburgh

Sleep Quality Index (PSQI) and Posttraumatic Growth Inventory

(PTGI).

Results

In the original study comparing MDMA with inactive

placebo along with the same psychotherapy PTSD was resolved

in 83% of the MDMA group vs. 25% of the placebo group receiv-

ing the same therapy. Improvement was maintained for at least

74% of subjects at long-term follow-up a mean of 45 months later.

In a more recent, unpublished, study both the high dose and the

medium dose of MDMA showed large effect sizes in reducing CAPS

scores, and improvements in secondarymeasures: and BDI-II, PSQI,

GAF and PTGI.

Conclusion

Evidence in phase II trials suggest that MDMA-

assisted psychotherapy is effective in treating PTSD in both civilians

and veterans who have not responded to established treatments.

Phase III trials are necessary to definitively establish safety and

efficacy of MDMA-assisted psychotherapy for PTSD.

Disclosure of interest

The author has not supplied his declaration

of competing interest.

http://dx.doi.org/10.1016/j.eurpsy.2016.01.798

JS08

Treatment of heroin dependence with

ibogaine

A. Schellekens

1 ,

, T . O

osteren

2 , T. K

nuijver

2 , R.J

. verkes

1 ,

M. Belgers

2

1

Radboud University Medical Centre, Donders Centre for

Neuroscience- department of Psychiatry – Nijmegen Institute for

Scientist Practitioners in Addiction, Nijmegen, Netherlands

2

IrisZorg, addiction care, Arnhem, Netherlands

Corresponding author.

Background

The use of the hallucinogen ibogaine as an anti-

addiction agent has been described in several case reports, dating

back to the eighties. The anti-addiction properties of ibogaine

have been confirmed in a large body of animal work. Ibogaine

has been shown to be effective in reducing withdrawal sever-

ity and substance use for a variety of substances, including

cocaine and opiates. Animal studies also show some potentially

dangerous adverse reactions, including cerebellar toxicity and

potential cardiac effects. While pharmacological treatment options

for opiate and cocaine dependence are still limited, ibogaine

assisted treatment might be a promising new option. Therefore

more systematic studies on its toxicity and efficacy are warr-

anted. In our studies we address these two research questions:

is ibogaine treatment for opiate dependence safe and effective

for treating opiate withdrawal and relapse prevention? A sec-

ondary objective is to explore the pharmacokinetic properties of

ibogaine.

Methods

Animal work: first we performed a systematic review

and meta-analysis of animal studies on ibogaine. Thirty studies

were included in the systematic review, of which 27 could be ana-

lyzed in meta-analysis. Human studies: fifteen opiate dependent

patients will be treated with ibogaine (10mg/kg), on top of treat-

ment as usual. Ibogaine toxicity will be assessed through close

monitoring with electrocardiography, with QTc prolongation as

main outcome measure, repeated assessments of ataxia using the

(SARA) and observation of psychotic symptoms by using the Delir-

ium Observations Scale (DOS). Ibogaine efficacy will be measured,

using repeated evaluations of opiate withdrawal severity (Subjec-

tive OpiateWithdrawal Scale: SOWS; Objective OpiateWithdrawal

Scale: OOWS), craving intensity (using a Visual Analogue Scale) and

substance use, with a six-month follow-up. Clinical observations

in ibogaine treated individuals will be compared with a cohort of

opiate dependent patients treated with a rapid detoxification pro-

cedure. Both acute and long-term effects will be linked with serum

ibogaine and noribogaine levels.

Results

Animal work: overall, ibogaine reduced drug self-

administration, particularly during the first 24 hours after

administration. Ibogaine had no effect on drug-induced con-

ditioned place preference. Ibogaine administration resulted in

motor impairment in the first 24 hours after supplementation,

and cerebral cell loss even weeks after administration. Data on

ibogaines effect on cardiac rhythm as well as on its neurophar-

macological working mechanisms are limited. Human studies:

human data are still being collected. Treatment of the first patients

confirmed strong effects of ibogaine on heart rhythm (QTc pro-

longation) and ataxia, while the opiate withdrawal symptoms

were relatively mild. The first observations on the clinical effect of

ibogaine on craving and substance use will also be shared.

Conclusions

Based on our meta-analysis of animal data, there is

strong evidence that ibogaine is effective in reducing drug self-

administration in animals. This warrants further studies into the

clinical efficacy of ibogaine in substance dependent patients in

reducing craving and substance use. Our first clinical experiences in