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

NCT00402298 | Terminated Phase 2 Results

• 1 other identifier: MP-3
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy can treat PTSD in participants with PTSD. Researchers will compare two sessions of MDMA-assisted therapy with two sessions of low dose (active placebo) MDMA-assisted therapy to determine if MDMA-assisted therapy is safe and works to treat PTSD symptoms. Participants will be randomly assigned to receive either the full dose of MDMA or low active placebo dose of MDMA during each of two experimental sessions. PTSD symptoms will be measured throughout the study.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; MDMA; therapy; Posttraumatic stress disorder; Israel

Outcome Measures

Primary Outcomes (1)

• Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-Month Follow-Up

  The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

  Baseline to two months after second MDMA-assisted experimental session

Secondary Outcomes (2)

• Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 6-Month Follow-Up

  Baseline to six months after second MDMA-assisted experimental session

• Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 12-month Follow-up

  Baseline to twelve months after second MDMA-assisted experimental session

Study Arms (2)

Full dose (125 mg) MDMA-assisted therapy

EXPERIMENTAL

Participants will receive an initial dose of 125 mg midomafetamine HCl followed 2.5 hours later by a supplemental dose of 62.5 mg midomafetamine HCl during the course of two day-long therapy sessions.

Drug: Full Dose Midomafetamine HCl

Active Comparator (25 mg) MDMA-assisted therapy

ACTIVE COMPARATOR

Participants will receive an initial dose of 25 mg midomafetamine HCl followed 2.5 hours later by a supplemental dose of 12.5 mg midomafetamine HCl during the course of two day-long therapy sessions.

Drug: Low Dose Midomafetamine HCl

Interventions

Full Dose Midomafetamine HCl DRUG

Participants will receive an initial dose of 125 mg midomafetamine HCl orally followed 2.5 hours later by 62.5 mg midomafetamine HCl orally during the course of a day-long therapy session.

Also known as: midomafetamine, 3,4-methylenedioxymethamphetamine, MDMA HCl, MDMA

Full dose (125 mg) MDMA-assisted therapy

Low Dose Midomafetamine HCl DRUG

Participants will receive an initial dose of 25 mg midomafetamine HCl orally followed 2.5 hours later by a supplemental dose of 12.5 mg midomafetamine HCl orally during the course of each of two day-long therapy sessions.

Also known as: midomafetamine, 3,4-methylenedioxymethamphetamine, MDMA HCl, MDMA

Active Comparator (25 mg) MDMA-assisted therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Posttraumatic stress disorder still remaining after at least one treatment, with treatment including psychotherapy or pharmacotherapy. At least two-thirds of participants will have PTSD as a result of war and terrorism
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lykos Therapeutics: lead

Study Sites (1)

Be'er Ya'akov Mental Health Center

Be’er Ya‘aqov, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Limitations and Caveats

This study was terminated after enrolling five subjects due to staff turnover and its effects on quality of data collection. Limited data were reported to the sponsor and its quality could not be assured and therefore analysis is limited to descriptive statistics of available data.

Results Point of Contact

• Title: Study Director
• Organization: Lykos Therapeutics

trialdata@lykospbc.com

877-627-7722

Study Officials

• Moshe Kotler

  Director of Psychiatry, Beer Yaakov Mental Health Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2006
• First Posted: November 22, 2006
• Study Start: May 27, 2007
• Primary Completion: March 1, 2009
• Study Completion: May 5, 2010
• Last Updated: June 5, 2025
• Results First Posted: September 20, 2021

Record last verified: 2025-05

Locations

IL (1)