Randomized Placebo-controlled Study of MDMA-assisted Psychotherapy in People With PTSD - Israel - Full Text View

Sponsor:	Multidisciplinary Association for Psychedelic Studies
Information provided by:	Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier:	NCT00402298

Purpose

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

Condition	Intervention	Phase
Posttraumatic Stress Disorder	Drug: 3,4-methylenedioxymethemphetmaine (MDMA_ Drug: 3,4-methylenedioxymethamphetamine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	MDMA-assisted Psychotherapy in Twelve People With War and Terrorism-related Posttraumatic Stress Disorder (PTSD)

Resource links provided by NLM:

MedlinePlus related topics: Club Drugs Post-Traumatic Stress Disorder

Drug Information available for: N-Methyl-3,4-methylenedioxyamphetamine

U.S. FDA Resources

Further study details as provided by Multidisciplinary Association for Psychedelic Studies:

Primary Outcome Measures:

Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Baseline, two months aftter second MDMA-assisted session, 6 and 12-months after second MDMA-assisted session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SCID diagnostic interview [ Time Frame: Screening ] [ Designated as safety issue: No ]
Impact of Events Scale (IES), baseline, two months after second experimental session, and six and 12 months after the second experimental session [ Time Frame: Baseline, two months after second MDMA-assisted session, 6 and 12 months after second MDMA-assisted session ] [ Designated as safety issue: No ]
Posttraumatic Diagnostic Scale (PDS) [ Time Frame: Baseline, day of MDMA sesison 1, day of MDMA sesison 2, two months after second MDMA-assisted session, 6 and 12 months after MDMA-assisted session ] [ Designated as safety issue: No ]
Symptom Checklist 90 - Revised (SCL90R), n [ Time Frame: at baseline, two months post second MDMA session, six and 12 months after second experimental MDMA sessio ] [ Designated as safety issue: No ]
Subjective Units of Distress [ Time Frame: every sixty to ninety minutes throughout each experimental or open-label session ] [ Designated as safety issue: Yes ]
Reactions to Research Participation Questionnaire (RRPQ), [ Time Frame: Twelve months after second experimental or open-label session ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	January 2008
Study Completion Date:	February 2011
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Participants will receive an initial dose of 125 mg MDMNA followed 2.5 hours later by a supplemental dose of 62.5 mg MDMA during the course of two day-long psychotherapy sessions.	Drug: 3,4-methylenedioxymethemphetmaine (MDMA_ Participants will receive an initial dose of 125 mg MDMA orally followed 2.5 hours later by 62.5 mg MDMA orally during the course of a day-long psychotherapy session.
Active Comparator: 2 25 and 12.5 mg MDMA	Drug: 3,4-methylenedioxymethamphetamine Participants will receive an initial dose of 25 mg MDMA orally followed 2.5 hours alter by a supplemental dose of 12.5 mg MDMA orally during the course of each of two day-long psychotherapy sessions.

Detailed Description:

Posttraumatic stress disorder (PTSD) occurs after experiencing a traumatic event or events. PTSD is a public health problem that causes a great deal of suffering. This study will examine whether two six to eight-hour long sessions of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy scheduled three to five weeks apart are safe, and whether combining a fully therapeutic dose of MDMA with psychotherapy, compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms, with symptoms measured four times, twice during the study, and during two follow-up assessments six and twelve months after the second experimental session. People who received the active placebo dose of MDMA can then take part in an "open label" study continuation, with the participant receiving a fully active dose of MDMA on two more six to eight hour-long psychotherapy sessions. Open-label means that the participants and the researchers know that the participant will receive the fully active dose of MDMA. People who receive the full dose of MDMA, and anyone who received low-dose MDMA and does not undergo the open-label study continuation will have PTSD symptoms measured six and twelve months after the second fully active or low dose MDMA session. People who take part in the open label study continuation have their PTSD symptoms checked six and 12 months after the second open label MDMA-assisted session.

MDMA is a substance that has unique effects that make it well suited to intensive psychotherapy. MDMA may belong to a new class of drugs, called entactogens, that produce feelings of closeness to others, empathy, well being, and insightfulness. Currently, MDMA is scheduled in the US and Israel, and doctors and therapists cannot give it to people outside of research studies like this one. Anecdotal reports of therapy conducted before MDMA was made illegal suggest that MDMA-assisted psychotherapy may benefit people with PTSD, and there is an ongoing placebo-controlled study of MDMA-assisted psychotherapy in people with crime or war-related PTSD occurring in the US.

This study will look at MDMA-assisted psychotherapy in 12 individuals aged 18 years or older diagnosed with PTSD that arose out of war or terrorism-related trauma, with PTSD symptoms not improving after trying at least one treatment. Eight of 12 participants will be assigned to receive the full dose of MDMA, and four will be assigned to receive a low or "active placebo" dose of MDMA during each of two experimental sessions. People will be assigned to full or low-dose MDMA "by chance," as by flipping a coin. The fully active dose consists of an initial dose of 125 mg MDMA and a supplemental dose of 62.5 mg given 2 to 2.5 hours later. The active placebo dose consists of an initial dose of 25 mg MDMA and a supplemental dose of 12.5 mg.

The study will last approximately four months, and will include two sixty minute long introductory psychotherapy sessions, two active placebo or fully active dose MDMA-assisted psychotherapy sessions, a sixty to ninety minute long psychotherapy session 24 hours after each experimental session, and one to two hour-long psychotherapy sessions occurring weekly between the first and second experimental session, and between the second experimental session and the end of the study.

PTSD symptoms will be measured at the start of the study and eight weeks (two months) after the second experimental session. PTSD symptoms are assessed six and twelve months after the second experimental session in people who do not take part in the open-label study continuation. People who take part in the open-label study continuation will have their PTSD symptoms measured six and twelve months after the second MDMA-assisted psychotherapy session.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402298

Locations

Israel
Beer Yaakov Mental Health Center
Beer Yaakov, Israel

Sponsors and Collaborators

Multidisciplinary Association for Psychedelic Studies

Investigators

Principal Investigator:

Moshe Kotler

Director of Psychiatry, Beer Yaakov Mental Health Center and Chair, Dept of Psychiatry, Tel Aviv University

More Information

No publications provided

Responsible Party:	Rick Doblin Ph.D., president, Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier:	NCT00402298 History of Changes
Other Study ID Numbers:	M-P3
Study First Received:	November 20, 2006
Last Updated:	April 1, 2011
Health Authority:	Israel: Ministry of Health

Keywords provided by Multidisciplinary Association for Psychedelic Studies:

PTSD
MDMA
psychotherapy
Posttraumatic stress disorder
Israel

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
N-Methyl-3,4-methylenedioxyamphetamine
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012