NCT05979844

MDMA-assisted Brief Cognitive Behavioral Conjoint Therapy for PTSD

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Dr. Leslie Morland · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this pilot trial is to examine the preliminary effectiveness of MDMA-facilitated bCBCT for improving chronic PTSD and relationship functioning in a sample of veterans and their intimate partners seeking care within the VA San Diego Healthcare System.

Detailed description

The pilot study is a single site, open-label study assessing the preliminary effectiveness, safety, and acceptability of MDMA-assisted therapy in combination with brief Cognitive Behavioral Conjoint Therapy in a sample of 8 veterans diagnosed with PTSD and their intimate partners (N = 16) within the Veterans Affairs San Diego Healthcare System (VASDHS). Therapy teams will deliver the 8 session bCBCT intervention combined with two full-day MDMA sessions for the Veteran diagnosed with PTSD. The veteran with PTSD will be given 80 mg of MDMA HCl with a 40 mg MDMA HCl supplemental dose in the first session and 100 mg of MDMA HCl with a supplemental dose of 40 mg MDMA HCl in the second. The intimate partner will be present for the MDMA sessions (unless they decline or it is clinically contraindicated) but will not receive MDMA. The couples will complete one preparatory session and at least two Emotion Focused Integrative sessions (five max). The PTSD+ veteran will receive telephone check-in calls every other business day for one week following each MDMA session. The first MDMA session occurs in the morning the business day after the preparatory session and the second MDMA session occurs in the morning within 5 business days after bCBCT Session 7. The Emotion-Focused Integrative Sessions take place the morning after each MDMA session. Outcomes examining PTSD symptom severity and relationship functioning will be evaluated for preliminary effectiveness. The study's screening, enrollment, and baseline phase lasts from pre-screen to baseline (approximately 12 weeks, +/- 2 weeks). The treatment period lasts from bCBCT Session 1 to bCBCT Session 8 (7 weeks -13 weeks). The follow-up period lasts from the post-treatment assessment to study termination (24 weeks +/- 15 days).

Conditions

• PTSD
• Relational Problems

Interventions

Type	Name	Description
DRUG	3,4-methylenedioxymethamphetamine (MDMA)	2 MDMA sessions; PTSD+ Veteran partner only
BEHAVIORAL	Brief Cognitive Behavioral Conjoint Therapy (bCBCT)	8 bCBCT sessions; Both partners

Timeline

• Start date: 2023-10-06
• Primary completion: 2025-11-14
• Completion: 2025-11-14
• First posted: 2023-08-07
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study