- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00090064
MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder
Phase II Clinical Trial Testing the Safety and Efficacy of 3,4-Methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Chronic Posttraumatic Stress Disorder
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Posttraumatic stress disorder (PTSD) occurs in response to a traumatic event or events. PTSD is a public health problem that causes a great deal of suffering and accounts for a significant portion of health care costs.
MDMA is a substance possessing unique effects that make it well suited to intensive psychotherapy. MDMA has been hypothesized to represent a new class of drugs, called entactogens, that produce feelings of closeness to others, empathy, well being, and insightfulness. Anecdotal reports of therapy conducted before MDMA was placed on Schedule I suggest that MDMA-assisted therapy may benefit people with PTSD.
This randomized, double-blind placebo-controlled pilot study assessed the safety and effectiveness of MDMA-assisted therapy among people with chronic, treatment-resistant PTSD, including veterans. Participants were assigned to receive either MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart during Stage 1 of the study. During these experimental sessions, participants received an initial dose of 125 mg of MDMA followed by a supplemental dose of 62.5 mg of MDMA, or they received initial and supplemental doses of inactive placebo. Psychotherapists and independent raters were blinded to participants' treatment conditions. This treatment period also consisted of non-drug preparatory therapy sessions and non-drug integration therapy sessions.
During Stage 2 of the study, the blind was broken and participants assigned to receive MDMA-assisted therapy in Stage 1 underwent a third open-label experimental session of MDMA-assisted therapy. Participants assigned placebo with therapy during Stage 1 who chose to enroll in Stage 2 underwent three open-label sessions of MDMA-assisted therapy. Outcome measures were administered two months after the second experimental session in Stage 1 and four to six weeks after the second MDMA-assisted therapy session in Stage 2. A final data-collection session took place at two months after the third experimental session.
The primary objective of the study was to measure change in PTSD symptoms via CAPS-IV across the study in participants receiving MDMA-assisted therapy versus placebo with therapy.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
South Carolina
-
Mount Pleasant, South Carolina, United States, 29464
- Offices of Michael Mithoefer MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
- Have had at least one unsuccessful attempt at treatment for PTSD with a SSRI and psychotherapy;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MDMA-assisted therapy
Participants will receive an initial dose of 125 mg MDMA orally followed 2 to 2.5 hours later by a second dose of 62.5 mg MDMA during two 8-hour long blinded therapy sessions.
|
Non-directive therapy provided by a team of two co-therapists
125 mg followed by a supplemental half-dose of 62.5 mg
Other Names:
|
Placebo Comparator: Placebo with therapy
Participants will receive an initial dose of 125 mg placebo orally followed 2 to 2.5 hours later by a second dose of 62.5 mg placebo during two 8-hour long blinded therapy sessions.
|
Non-directive therapy provided by a team of two co-therapists
125 mg followed by a supplemental half-dose of 62.5 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up
Time Frame: Baseline to 2 months post second experimental session
|
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.
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 2 months post second experimental session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Impact of Events Scale Revised (IES-R) From Baseline to 2-month Follow-up
Time Frame: Baseline to 2 months post second experimental session
|
The Impact of Events Scale Revised (IES-R) is a 22-item self-report measure (for DSM-IV) designed to measure the extent to which a given stressful life event produces subjective distress.
Each item corresponds directly to 14 of the 17 DSM-IV symptoms of PTSD and is rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") for the extent to which the item was true for the participant during the past seven days.
The IES-R yields a total score ranging from 0 to 88 with higher scores indicated greater distress.
|
Baseline to 2 months post second experimental session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Mithoefer, MD, Private Practice
Publications and helpful links
General Publications
- Jerome L, Feduccia AA, Wang JB, Hamilton S, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials. Psychopharmacology (Berl). 2020 Aug;237(8):2485-2497. doi: 10.1007/s00213-020-05548-2. Epub 2020 Jun 4.
- Feduccia AA, Jerome L, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline. Front Psychiatry. 2019 Sep 12;10:650. doi: 10.3389/fpsyt.2019.00650. eCollection 2019.
- Mithoefer MC, Feduccia AA, Jerome L, Mithoefer A, Wagner M, Walsh Z, Hamilton S, Yazar-Klosinski B, Emerson A, Doblin R. MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials. Psychopharmacology (Berl). 2019 Sep;236(9):2735-2745. doi: 10.1007/s00213-019-05249-5. Epub 2019 May 7.
- Mithoefer MC, Wagner MT, Mithoefer AT, Jerome L, Doblin R. The safety and efficacy of +/-3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. J Psychopharmacol. 2011 Apr;25(4):439-52. doi: 10.1177/0269881110378371. Epub 2010 Jul 19. Erratum In: J Psychopharmacol. 2011 Jun;25(6):852.
- Mithoefer MC, Wagner MT, Mithoefer AT, Jerome L, Martin SF, Yazar-Klosinski B, Michel Y, Brewerton TD, Doblin R. Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study. J Psychopharmacol. 2013 Jan;27(1):28-39. doi: 10.1177/0269881112456611. Epub 2012 Nov 20.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Trauma and Stressor Related Disorders
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Hallucinogens
- Adrenergic Uptake Inhibitors
- N-Methyl-3,4-methylenedioxyamphetamine
Other Study ID Numbers
- MP1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Posttraumatic Stress Disorder
-
University Hospital, ToursCompletedPostTraumatic Stress DisorderFrance
-
The University of Texas Health Science Center at...University of Pennsylvania; Brooke Army Medical Center; C.R.Darnall Army Medical... and other collaboratorsCompletedPosttraumatic Stress Disorder (PTSD)United States
-
Icahn School of Medicine at Mount SinaiCompletedPosttraumatic Stress Disorder (PTSD)United States
-
Berlin Center for the Treatment of Torture VictimsCompletedPosttraumatic Stress Disorder (PTSD)Germany
-
VA Office of Research and DevelopmentCompletedPosttraumatic Stress Disorder (PTSD)United States
-
Michael E. DeBakey VA Medical CenterSouth Central VA Mental Illness Research, Education & Clinical CenterCompletedPosttraumatic Stress Disorder (PTSD)United States
-
TEMPVA Research Group, Inc.C.R.Darnall Army Medical Center; VA Boston Healthcare System; Central Texas Veterans...UnknownPosttraumatic Stress Disorder, Combat-relatedUnited States
-
VA Office of Research and DevelopmentCompletedPosttraumatic Stress Disorder (PTSD)United States
-
VA Office of Research and DevelopmentCompleted
-
Yale UniversityNational Center for PTSDCompletedPosttraumatic Stress Disorder (PTSD)United States
Clinical Trials on Therapy
-
University of Alabama at BirminghamCompleted
-
Mennallah Ahmed Mohamed Anwar ElgendyNot yet recruiting
-
Spaulding Rehabilitation HospitalActive, not recruiting
-
Istanbul Medipol University HospitalCompleted
-
St. Jude Children's Research HospitalCompletedStem Cell Transplant | Bone MarrowUnited States, Canada
-
Universidad de ZaragozaCompletedPlagiocephaly | Plagiocephaly, Nonsynostotic | Plagiocephaly, PositionalSpain
-
National Taiwan University HospitalNot yet recruitingAutism | Language Delay | Speech Disorders in Children
-
Hospital for Special Surgery, New YorkActive, not recruiting
-
Maastricht Radiation OncologyUniversity of Pennsylvania; Philipps University Marburg Medical Center; University...CompletedCarcinoma, Squamous Cell of Head and NeckNetherlands