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RECRUITINGPhase 2INTERVENTIONAL

MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder

A Randomized, Double-Blind, Single-Site Phase II 2-Arm Study to Compare the Safety and Preliminary Efficacy of Manualized MDMA-Assisted Therapy to Low Dose D-Amphetamine Assisted Therapy in Veterans For The Treatment of Moderate to Severe PTSD

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This randomized, double-blind, single-site phase II 2-arm study will investigate the safety and preliminary efficacy of MDMA-assisted therapy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in participants aged 18 years and older with PTSD of at least moderate severity.

Who May Be Eligible (Plain English)

Who May Qualify: - At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months. - Fluent in speaking and reading the predominantly used or recognized language of the study site (English). - Must be a veteran enrolled at a VA Healthcare Center in the Greater Los Angeles area. - Able to swallow pills. - Agree to have study visits audiovisually recorded, including Experimental Sessions, IR assessments, and non-drug therapy sessions. - Able to provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of the participant becoming unwell or unreachable. - Able to identify appropriate support person(s) to stay with the participant on the evenings of Experimental Sessions if needed. - May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease. - May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed. - Body weight of at least 45 kilograms (kg). Participants with a body weight of 45-48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg/m2. BMI must be within 18 to 32 kg/m2 (inclusive). - A person able to be pregnant (PABP) must use a highly effective contraceptive method. Who Should NOT Join This Trial: - Are not able to give adequate willing to sign a consent form. - Have evidence or history of significant medical or psychiatric disorders. - Are abusing illegal drugs. - Unable or unwilling to safely taper off prohibited psychiatric medication. - Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months. * Fluent in speaking and reading the predominantly used or recognized language of the study site (English). * Must be a veteran enrolled at a VA Healthcare Center in the Greater Los Angeles area. * Able to swallow pills. * Agree to have study visits audiovisually recorded, including Experimental Sessions, IR assessments, and non-drug therapy sessions. * Able to provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of the participant becoming unwell or unreachable. * Able to identify appropriate support person(s) to stay with the participant on the evenings of Experimental Sessions if needed. * May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease. * May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed. * Body weight of at least 45 kilograms (kg). Participants with a body weight of 45-48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg/m2. BMI must be within 18 to 32 kg/m2 (inclusive). * A person able to be pregnant (PABP) must use a highly effective contraceptive method. Exclusion Criteria: * Are not able to give adequate informed consent. * Have evidence or history of significant medical or psychiatric disorders. * Are abusing illegal drugs. * Unable or unwilling to safely taper off prohibited psychiatric medication. * Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician.

Treatments Being Tested

DRUG

3,4-methylenedioxymethamphetamine

Initial doses per Experimental Session include 68 mg or 100 mg MDMA (equivalent to 80 mg or 120 mg MDMA HCl), followed 1.5 to 2 hours later by a supplemental dose of 34 mg or 50 mg MDMA (equivalent to 40 mg or 60 mg MDMA HCl).

DRUG

d-amphetamine

Initial dose per experimental session will be 5 mg or 10 mg d-amphetamine, followed 1.5 to 2 hours later by supplemental dose of 2.5 mg or 5 mg d-amphetamine.

BEHAVIORAL

Therapy

Participants assigned to MDMA and d-amphetamine will undergo a therapeutic approach, which is detailed in the MDMA-Assisted Therapy Treatment Manual and administered by MAPS-trained therapists. In brief, this therapy is guided by the subject's own recollections of traumatic events. The subject and two therapists provide a comfortable and supportive environment and allow the subject to guide the discussion. Subjects are encouraged to experience and express fear, anger, and grief with less likelihood of feeling overwhelmed by these emotions. MDMA seems to engender internal awareness that even painful feelings that arise are an important part of the therapeutic process. In addition, feelings of empathy, love, and deep appreciation often emerge, along with a clearer perspective of the trauma as a past event, a more accurate perspective about its significance, and a heightened awareness of the support and safety that exists in the present.

Locations (2)

VA Greater Los Angeles Healthcare System, Westwood campus
Los Angeles, California, United States
West Los Angeles Veteran Affairs
Los Angeles, California, United States