MDMA-Assisted Therapy for Veterans with Moderate to Severe Post Traumatic Stress Disorder
- Conditions
- Post Traumatic Stress Disorder
- Interventions
- Registration Number
- NCT05790239
- Lead Sponsor
- Stephen Robert Marder
- Brief Summary
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.
- Detailed Description
This randomized, double-blind, single-site phase II 2-arm study will compare MDMA-assisted therapy with low dose d-amphetamine-assisted therapy to treat PTSD symptoms in veteran participants aged 18 years and older with PTSD of at least moderate severity, as measured by the change in CAPS-5 total severity score. The study will be conducted in up to N=40 participants from the Greater Los Angeles VA randomized with a 1:1 allocation to Group 1: MDMA-assisted therapy or Group 2: low dose d-amphetamine assisted therapy.
For each participant, the study will consist of:
* Screening Period: phone screen, informed consent, eligibility assessment, Screening CAPS-5, and Initial Enrollment of eligible participants.
* Preparatory Period: medication tapering, three Preparatory Sessions, baseline assessments (including Baseline CAPS-5), leading to Enrollment Confirmation.
* Treatment Period: three Experimental Sessions, and three Integrative Sessions following each Experimental Session including CAPS-5 assessments.
* Follow-up Period and Study Termination: Primary Outcome CAPS-5 assessment and Study Termination visit.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low Dose D-Amphetamine Assisted Therapy d-amphetamine Participants will receive a flexible divided dose plus therapy at Experimental Sessions. MDMA-Assisted Therapy Therapy Participants will receive a flexible divided-dose of MDMA plus therapy at Experimental Sessions. Low Dose D-Amphetamine Assisted Therapy Therapy Participants will receive a flexible divided dose plus therapy at Experimental Sessions. MDMA-Assisted Therapy 3,4-methylenedioxymethamphetamine Participants will receive a flexible divided-dose of MDMA plus therapy at Experimental Sessions.
- Primary Outcome Measures
Name Time Method Compare changes in PTSD symptom severity in the MDMA vs active control group. Visit 17 (approximately 14 weeks after enrollment) The Primary Outcome measure will be the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score from Baseline to Visit 17, assessed by a blinded study staff rater.
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.
- Secondary Outcome Measures
Name Time Method Compare changes in clinician-rated functional impairment in the MDMA vs active control group. Visit 17 (approximately 14 weeks after enrollment) The secondary outcome measure will be the change in the Sheehan Disability Scale (SDS), assessed by a blinded study staff rater.
The SDS is a 5-item measure of functional impairment. The items indicate the degree of impairment in the domains of work/school, social life, and home life, with response options based on a 10-point scale (0=not at all to 10=extremely), and five verbal tags (not at all, mildly, moderately, markedly, extremely). The first three items indicate the degree of impairment in the domains of work/school, social life, and home life, with response options based on a 10-point scale (0=not at all to 10=extremely), and five verbal tags (not at all, mildly, moderately, markedly, extremely). The remaining two items assess Days Lost and Days Unproductive during the reporting period.
The three numerical items can be scored, and total scores range from 0 to 30, with higher scores indicating higher impairment.
Trial Locations
- Locations (2)
West Los Angeles Veteran Affairs
🇺🇸Los Angeles, California, United States
VA Greater Los Angeles Healthcare System, Westwood campus
🇺🇸Los Angeles, California, United States