Clinical trial
Phase II Clinical Trial Testing the Safety and Efficacy of 3,4-Methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Chronic Posttraumatic Stress Disorder
Name
MP1
Description
The goal of this clinical trial is to compare MDMA-assisted therapy to placebo with therapy in people with chronic, treatment-resistant posttraumatic stress disorder (PTSD). The main question it aims to answer is: Is there a reduction in PTSD symptoms among people given MDMA-assisted therapy compared to placebo with therapy?
Participants will receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart. During experimental sessions, participants receive an initial dose of 125 mg of MDMA, or placebo, followed by a dose of 62.5 mg of MDMA, or placebo. During this treatment period, participants will also undergo non-drug preparatory psychotherapy sessions and non-drug integrative sessions.
The study will test whether MDMA-assisted therapy can be safely given to participants. Researchers will compare PTSD symptoms in the MDMA-assisted therapy group to the placebo with therapy group to see if there is a reduction in symptoms after the treatment period.
Trial arms
Trial start
2004-03-12
Estimated PCD
2008-05-02
Trial end
2010-06-21
Status
Completed
Phase
Early phase I
Treatment
Midomafetamine
125 mg followed by a supplemental half-dose of 62.5 mg
Arms:
MDMA-assisted therapy
Other names:
MDMA, 3,4-methylenedioxymethamphetamine
Lactose placebo pill
125 mg followed by a supplemental half-dose of 62.5 mg
Arms:
Placebo with therapy
Other names:
Placebo
Therapy
Non-directive therapy provided by a team of two co-therapists
Arms:
MDMA-assisted therapy, Placebo with therapy
Size
23
Primary endpoint
Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up
Baseline to 2 months post second experimental session
Eligibility criteria
Inclusion Criteria:
* Have current PTSD (within the past 6 months) in response to crime victimization, including childhood sexual or physical abuse, or meet criteria for PTSD in response to combat;
* Have a CAPS score showing moderate to severe PTSD symptoms;
* They must either:
1. Have had at least one unsuccessful attempt at treatment for PTSD with a SSRI and psychotherapy;
2. Be a veteran with PTSD symptoms that have endured for no less than one year but no more than five years
* Be at least 18 years old;
* Must be generally healthy;
* Willing to remain overnight at the study site;
* Agree to have transportation home the morning after experimental sessions;
* Are willing to be contacted via telephone for all necessary telephone contacts;
* Must have a negative pregnancy test if able to bear children and agree to use an effective form of birth control;
* Are proficient in reading English;
Exclusion Criteria:
* Are pregnant or nursing, or are able to bear children and are not practicing an effective means of birth control;
* Weigh less than 50 kg or more than 105 kg;
* Are unable to give adequate informed consent;
* Have a history of certain excluded medical disorders.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 23, 'type': 'ACTUAL'}}
Updated at
2024-02-29
1 organization
2 products
1 indication
Organization
Lykos TherapeuticsProduct
MidomafetamineIndication
Post-Traumatic Stress DisorderProduct
Lactose placebo