MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic PTSD

NCT02876172 | Completed Phase 1 Results

• 1 other identifier: MPVA-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if cognitive-behavioral conjoint therapy (CBCT) in combination with MDMA-assisted therapy is safe and effective in people with chronic PTSD and their partners. The main question it aims to answer is: Does MDMA-assisted CBCT reduce PTSD symptoms in people with chronic PTSD? Participants (chronic PTSD patients and their partners) will undergo three non-drug preparatory therapy sessions, followed by two MDMA-assisted therapy sessions. Each MDMA-assisted therapy session will be followed by five non-drug integrative therapy using CBCT.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; therapy; MDMA; dyad; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (2)

• Primary Endpoint Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score

  The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. 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.

  Primary Endpoint (Visit 16, approximately 2 months later)

• Change From Baseline to Primary Endpoint CAPS-5 Total Severity Score

  The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. 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.

  Baseline to Primary Endpoint (Visit 16, approximately 2 months later)

Secondary Outcomes (18)

• Baseline Pittsburgh Sleep Quality Index (PSQI)

  Baseline (screening)

• Primary Endpoint Pittsburgh Sleep Quality Index (PSQI)

  Primary Endpoint (Visit 16, approximately 2 months later)

• Baseline Patient Beck Depression Inventory-II (BDI-II)

  Baseline (screening)

• Primary Endpoint Patient Beck Depression Inventory-II (BDI-II)

  Primary Endpoint (Visit 16, approximately 2 months later)

• Baseline Patient Couples Satisfaction Index (CSI)

  Baseline (screening)

Study Arms (1)

MDMA-assisted therapy and CBCT

EXPERIMENTAL

Cognitive-behavioral conjoint therapy and 2 sessions of MDMA-assisted therapy.

Drug: MDMA; Behavioral: CBCT; Behavioral: Therapy

Interventions

MDMA DRUG

Two sessions of MDMA-assisted therapy, one with an initial dose of 75 mg midomafetamine HCl (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg midomafetamine HCl (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.

Also known as: 3,4-Methylenedioxymethamphetamine, midomafetamine

MDMA-assisted therapy and CBCT

CBCT BEHAVIORAL

A three-phase, 15-session, manualized treatment from the CBCT manual

Also known as: Cognitive behavioral conjoint therapy

MDMA-assisted therapy and CBCT

Therapy BEHAVIORAL

Manualized MDMA-assisted therapy

MDMA-assisted therapy and CBCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PTSD+ participant: Meet DSM-5 criteria for current PTSD and satisfies PTSD criteria via CAPS
• CSO participant: Meet criteria for V62.89 Other Problem Related to Psychosocial Circumstances under Diagnostic and Statistical Manual 5 (DSM-5), as determined through clinical interview, for current psychosocial circumstances contributing to relationship distress with intimate or non-intimate partner
• Are at least 18 years old
• If in psychotherapy, willing and able to maintain that schedule without changing it
• Are willing to refrain from taking any psychiatric medications during the study period, with the exception of gabapentin when prescribed for pain control.
• Willing to remain overnight at the study site
• Are willing to be driven home the morning after the experimental sessions, after the integrative therapy session
• Are willing to commit to medication dosing, experimental sessions, follow-up sessions, to complete evaluation instruments and commit to be contacted for all necessary telephone contacts
• Are willing to remain overnight at the study site after each experimental session until after the integrative session occurring the next morning
• Must have a negative pregnancy test at study entry and prior to each experimental session if able to bear children, and must agree to use adequate birth control through 10 days after the last dose of MDMA.
• Must provide a contact (relative, spouse, close friend or other caregiver other than the CSO participant) who is willing and able to be reached by the Clinical Investigators in the event of a participant becoming suicidal.
• Must agree to inform the Clinical Investigators within 48 hours of any medical conditions and procedures
• Are proficient in speaking and reading English
• Agree to have all clinic visit and Integrative Sessions recorded to audio and video
• Agree to not participate in any other interventional clinical trials during the duration of this study

You may not qualify if:

• CSO participant only: Have diagnosis of current PTSD not in remission
• Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control
• Have evidence or history of significant medical disorders
• Have hypertension
• Have liver disease; asymptomatic participants with Hepatitis C who have previously undergone evaluation and successful treatment is permitted.
• History of hyponatremia or hyperthermia
• Weigh less than 48 kg
• Have used "Ecstasy" (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the MDMA-assisted session
• Are not able to give adequate informed consent

Sponsors & Collaborators

• Lykos Therapeutics: lead

Study Sites (1)

Offices of Michael Mithoefer MD

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Lykos Therapeutics

trialdata@lykospbc.com

877-627-7722

Study Officials

• Michael C Mithoefer, MD

  Private Practice

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 23, 2016
• Study Start: July 3, 2016
• Primary Completion: December 16, 2017
• Study Completion: May 29, 2018
• Last Updated: June 4, 2025
• Results First Posted: July 19, 2021

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After study data lock

Locations

US (1)