mdma-assisted therapy for veterans with moderate to severe post traumatic stress disorder

Conditions: Post Traumatic Stress Disorder

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.

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.

Eligibility criteria:
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.

Keywords: mdma post traumatic stress disorder ptsd functional impairment veteran substance use disorder chronic pain