Randomized Placebo-controlled Study of MDMA-assisted Therapy in People With PTSD - Israel

• Status: Terminated
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of the safety and efficacy of MDMA-assisted therapy in people with war or terrorism-related posttraumatic stress disorder (PTSD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Multidisciplinary Association for Psychedelic Studies
• Treatments: N-Methyl-3,4-methylenedioxyamphetamine

Criteria

Inclusion Criteria:

• Diagnosis of Posttraumatic stress disorder arising from war or terrorism-related events.

• PTSD still remains after at last one treatment, with treatment including psychotherapy or pharmacotherapy.

• May meet criteria for a mood disorder.

• Must be at least 18 years old.

• Must be able to stop taking psychiatric medication from the start of the study until the two-month follow-up.

• May continue seeing an outside therapist during the study, but cannot increase the length or frequency of treatments.

• Must be able to follow all the rules and instructions relating to the experimental session, including restrictions on food and substance (alcohol and drug) consumption

• Must be willing to stay overnight in the clinic after each experimental session until the non-drug session occurring the next morning.

• Must be willing to be contacted by one of the researchers on a daily basis for a week after each experimental session.

• If a woman of childbearing potential, must have a negative pregnancy test and must agree to use an effective form of birth control.

• Must be able to speak and read Hebrew.

Exclusion Criteria:

• Cannot have a non-war or non-terrorism event as significant contributor to PTSD symptoms.

• Cannot have history of or be diagnosed with psychotic disorder or bipolar affective disorder - 1.

• Cannot be diagnosed with dissociative identity disorder, an eating disorder with active purging or borderline personality disorder.

• Cannot have evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder. (People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).

• Cannot have uncontrolled hypertension, peripheral vascular disease, hepatic disease (with or without abnormal liver enzymes), or history of hyponatremia or hyperthermia.

• Cannot weigh less than 50 or more than 105 kg.

• Cannot have used "Ecstasy" more than five times during lifetime or in the past six months.

• Cannot present a serious suicide risk or be likely to require hospitalization during the course of the study.

• Cannot require ongoing concomitant therapy with a psychotropic drug.

• Cannot meet DSM-IV criteria for substance abuse or dependence for any substance save caffeine or nicotine in the past 60 days.

• Unable to give adequate consent.