MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder: A Randomized Controlled Trial
The study investigators are conducting the first randomized placebo-controlled trial of MDMA-assisted therapy with a comorbid sample of military Veterans with a co-occurring diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of three once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy. The primary objective of the proposed project is to evaluate safety and clinical outcomes of MDMA-assisted therapy compared to identical psychotherapy with low dose (active placebo) MDMA for the treatment of PTSD-AUD in military Veterans. The Primary Outcome measures, the Clinician Administered PTSD Scale (CAPS-5) and Inventory of Psychosocial Functioning (IPF), will evaluate changes in PTSD symptoms and psychosocial outcomes over time. Changes in drinking outcomes will also be evaluated (via the Timeline Followback, TLFB).
∙ Participants are eligible to be included in the study if all the following criteria apply:
∙ Age
• Are at least 18 years old at the time of signing the informed consent.
• Type of Participant and Disease Characteristics
• Are currently enrolled in VA care.
• Veterans must have initiated and discontinued (or completed) at least one first-line evidence-based treatment (EBT) for PTSD alone, for PTSD and AUD together, or for a dual-diagnosis condition, as documented in CPRS.
• Are fluent in speaking and reading English.
• At Screening, Veterans must meet past 3-month criteria for Alcohol Use Disorder as measured by the SCID-5.
• Must have a desire to abstain or reduce alcohol use, per Veteran report.
• Able to safely abstain from alcohol for at least 48 hours without requiring medical detox.
• At Screening (V0) have a confirmed diagnosis of PTSD with symptom duration of at least 6 months and a total severity score of \>28 per the CAPS-5.
• a.At Baseline (V3) must continue to have a confirmed diagnosis of PTSD per CAPS-5.
• Are able to swallow pills.
⁃ Agree to have study visits recorded, including Experimental Sessions, 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 a participant becoming unwell or unreachable.
⁃ Able to identify an appropriate support person to stay with the participant on the evenings of the Experimental Sessions.
⁃ Weight
⁃ Body Mass Index (BMI) in the range of 18-35.
⁃ Sex and Contraceptive/ Barrier Requirements
⁃ For participants assigned female sex at birth:
‣ A participant is eligible to participate if not pregnant, not planning to become pregnant, or is not breastfeeding and one of the following conditions applies: oIs not able to become pregnant OR oIs a person able to be pregnant (PABP) and using a contraceptive method that is highly effective, with a failure rate of \<1%. The investigator will evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first does of study intervention.
‣ A PABP must have a highly sensitive negative urine pregnancy test at study entry and prior to each Experimental Session, see Schedule of Activities.
⁃ Informed Consent
⁃ Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
⁃ Other Inclusions
⁃ Agree to inform the investigators within 48 hours of any medical conditions and procedures.
⁃ May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
⁃ May have a history of or current Diabetes Mellitus (Type 2) if additional screening measures of Hemoglobin A1c levels are less than 7, identifying that the Type 2 diabetes is well controlled, if the condition is judged to be stable on effective management, and with approval by the study clinician.
⁃ May have hypothyroidism if taking adequate and stable thyroid replacement medication.
⁃ May have a history of, or current, glaucoma if approval for study participation is received from an ophthalmologist.