MDMA-assisted Brief Cognitive Behavioral Conjoint... — Clinical Trial Details

Participants

Ages

18 – 99

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

Inclusion Criteria:
1. Be a veteran (≥18 years) who meets criteria for PTSD on the CAPS-5 or be an intimate partner (≥18 years) of a veteran meeting PTSD criteria who is willing to participate and does not meet PTSD criteria on the PCL-5 (score ≤30).
2. Be in a committed relationship for ≥12 months and cohabiting.
3. Fluent in English.
4. Willing to commit to medication dosing, therapy sessions, follow-up, and telephone contact.
5. Able to swallow pills (PTSD+ veteran only).
6. Agree to study visit recording and Independent Rater assessments for bCBCT sessions.
7. Provide a local contact willing to be reached if participant becomes suicidal or unreachable (PTSD+ veteran only).
8. Agree to inform investigators of new medical conditions/procedures within 48 hours.
9. If able to become pregnant, have a negative pregnancy test at entry and prior to each MDMA session and use adequate birth control through 10 days after last MDMA session (PTSD+ veteran only).
10. Agree to fasting and medication restrictions prior to MDMA sessions (PTSD+ veteran only).
11. Not enroll in other interventional trials during study.
12. Both partners agree not to begin new mental healthcare during screening or treatment without PI approval; ongoing non-PTSD-focused care may continue if not increased in frequency.
13. At pre-screen, PTSD+ veteran: PCL-5 ≥40; at screening CAPS-5 total severity score ≥28.
14. May have well-controlled hypertension, treated HCV, stable diabetes type 2, or hypothyroidism with stable treatment if cleared by study physician.
15. May have alcohol or substance use disorder if not in withdrawal and with a realistic plan to reduce use agreed by investigators.

Exclusion Criteria

Exclusion Criteria:
1. Unable to provide informed consent.
2. Currently engaged in compensation & pension litigation where financial gain could result from prolonged PTSD symptoms.
3. Likely to be re-exposed to index trauma, lack social support, or lack stable housing.
4. Ecstasy/MDMA use >10 times in past 10 years or any use within 6 months of first MDMA session (PTSD+ veteran only).
5. Any current problem that interferes with safe participation or adherence.
6. Hypersensitivity to any ingredient of the IMP (PTSD+ veteran only).
7. ECT within 12 weeks prior to enrollment (PTSD+ veteran only).
8. History or current primary psychotic disorder.
9. History or current Bipolar I/II or manic episode (PTSD+ veteran only).
10. Current eating disorder with active purging (PTSD+ veteran only).
11. Current MDD with psychotic features.
12. Current panic disorder (PTSD+ veteran only).
13. Current alcohol or substance use disorder (other than caffeine/nicotine) deemed a safety concern or likely to interfere with therapy; failure to agree to/manage use excludes enrollment.
14. Current serious suicide risk per C-SSRS or clinical interview; scores of 4+ on C-SSRS within last 6 months at weekly frequency or any suicidal behaviour/attempt within last 6 months exclude enrollment.
15. Reported intimate partner violence or severe relationship aggression meeting E-HITS ≥7 or 'severe' on CTS-2 psychological aggression (safety concern).
16. Present a serious risk to others per clinical interview.
17. Require ongoing psychiatric medication except protocol-allowed exceptions (PTSD+ veteran).
18. Medical conditions making sympathomimetic use unsafe (e.g., recent MI, stroke, aneurysm) unless cleared; uncontrolled hypertension (≥140/90), significant arrhythmia, WPW not ablated, marked QTc prolongation (>450 ms), symptomatic liver disease or significant enzyme elevations, history of hyponatraemia/hyperthermia.
19. Weigh <48 kg.
20. Pregnant or nursing or unwilling/unable to use effective contraception.
21. Ketamine-assisted therapy or ketamine use within 12 weeks of enrollment.
22. Preexisting conditions affecting renal function.

Company

Product

Legal

MDMA-assisted Brief Cognitive Behavioral Conjoint Therapy for PTSD (MDMA-bCBCT)

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

bCBCT + MDMA

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details