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PTSDPhase 3MDMA-bCBCTNCT05979844

MDMA-assisted Brief Cognitive Behavioral Conjoint Therapy for PTSD

A Phase 3 study testing 3,4-methylenedioxymethamphetamine (MDMA) and Brief Cognitive Behavioral Conjoint Therapy (bCBCT) in people with PTSD and Relational Problems, run by Dr. Leslie Morland at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
PTSD, Relational Problems
What is being tested?
3,4-methylenedioxymethamphetamine (MDMA) and Brief Cognitive Behavioral Conjoint Therapy (bCBCT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
6 Oct 2023to 14 Nov 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be a veteran (age 18 years or older) who meets criteria for PTSD on the CAPS-5 or be an intimate partner (age 18 or older) of a veteran meeting the criteria for PTSD who is willing to participate in the intervention and who does not meet criteria for PTSD on the PCL-5 (i.e., must score a 30 or lower).
  • Be in a committed relationship together of at least 12 months, and be cohabiting.
  • Be fluent in speaking and reading English.
  • Are willing to commit to medication dosing, therapy sessions, follow-up sessions, completing evaluation instruments, and all necessary telephone contact.
  • Be able to swallow pills. (PTSD+ veteran only)
  • Agree to have study visits recorded, including Experimental MDMA Sessions, and be aware that Independent Rater assessments for bCBCT sessions will occur.
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  • 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 suicidal or unreachable. (PTSD+ veteran only)
  • Agree to inform the investigators within 48 hours of any new medical conditions or procedures.
  • If able to become pregnant (i.e., assigned female at birth, fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a highly sensitive negative pregnancy test at study entry and prior to each Experimental MDMA Session, and must agree to use adequate birth control through 10 days after the last Experimental MDMA Session. Adequate birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e., condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). (PTSD+ veteran only)
  • Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Experimental MDMA Sessions. (PTSD+ veteran only)
  • Not enroll in any other interventional clinical trials during the duration of the study, and commit to medication dosing, therapy, and study procedures.
  • Both partners agree to not begin a new form of mental healthcare during the screening or treatment phases of the trial, without first discussing with the PI in consultation with the study physician.
  • It is acceptable for participants to continue ongoing non-PTSD focused or non-couple-based mental healthcare, if it is not increased in frequency or specifically excluded by the study protocol.
  • All ongoing therapies should be documented by the site and discussed with the study physician prior to enrollment to avoid confounding treatment effects. In some instances, the study physician may request that the participant delay enrollment until their planned course of therapy is complete, and an integration period has elapsed.
  • Participants may continue with PTSD focused and/or couple-based mental health care during the screening period prior to Baseline and following treatment period prior to study termination if they have approval from the study PI and their study provider (as applicable).
  • Medical History - PTSD+ veteran only unless otherwise noted
  • At Pre-Screening, have at least moderate PTSD symptoms in the last month based on PCL-5 total score of 40 or greater (index).
  • 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.
  • At Screening, have at least moderate PTSD per CAPS-5 and symptoms in the last month constituting a CAPS-5 Total Severity Score of 28 or greater (index).
  • May have alcohol or substance use disorder if participant is not in withdrawal or requiring detox. Participants/couples must have a plan, agreed upon by investigator, therapy team, and study physician, to reduce use of alcohol or other substances and to manage symptoms without self-medicating. Enrollment will require that, in the judgment of the investigator, therapy team, and study physician, the plan for decreasing substance use is realistic and has a good chance of succeeding in order to prevent substance use from impacting the safety or effectiveness of the investigational treatment. (Both partners)
  • May have a history of or current Diabetes Mellitus (Type 2) if additional screening measures rule out underlying cardiovascular disease, if the condition is judged to be stable on effective management, and with approval by the study physician.
  • 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.

Who cannot join

  • Are not able to give adequate informed consent.
  • Are currently engaged in compensation and pension (C\&P) litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders.
  • Are likely, in the investigator's opinion and via assessment period, to be re- exposed to their index trauma or other significant trauma, lack social support, or lack a stable living situation
  • 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 first Experimental MDMA Session. (PTSD+ veteran only)
  • Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation due to it impacting the patient's safety and/or ability to participate in the protocol
  • Have hypersensitivity to any ingredient of the Investigational Medicinal Product (IMP). (PTSD+ veteran only)
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  • Psychiatric History - both members of dyad unless otherwise noted
  • Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment. (PTSD+ veteran only)
  • Have a history of or a current primary psychotic disorder assessed via the DIAMOND and clinical interview
  • Have a history of or a current Bipolar I disorder, Bipolar 2 disorder, or manic episode assessed via the DIAMOND and clinical interview (PTSD+ veteran only)
  • Have a current eating disorder with active purging assessed via DIAMOND and clinical interview. (PTSD+ veteran only)
  • Have current major depressive disorder with psychotic features assessed via DIAMOND
  • Have current panic disorder assessed via DIAMOND (PTSD+ veteran only)
  • Have a current alcohol or substance use disorder other than caffeine or nicotine that the investigators, therapy team, and/or study physician judge to be a safety concern for enrollment in the study or that could interfere with the therapeutic process or with other aspects of study participation. Any participant who is not able to agree or adhere to a plan to reduce use and manage symptoms will not be enrolled
  • Present with current serious suicide risk, as determined through psychiatric interview, responses to C-SSRS (scores of four or greater), and clinical judgment of the investigator; however, history of suicide attempts is not an exclusion. Any participant who is likely to require hospitalization related to suicidal ideation and behavior, in the judgment of the investigator, will not be enrolled. Any participant presenting with the following on the pre-screen C-SSRS will be excluded:
  • Suicidal ideation score of 4 or greater within the last 6 months of the assessment at a frequency of once a week or more
  • Any suicidal behavior, including suicide attempts or preparatory acts, within the last 6 months of the assessment. Participants with non-suicidal self- injurious behavior may be included if approved by the study physician
  • Report intimate partner violence or severe relationship aggression, as defined by meeting either of the following criteria, that that the investigators and/or therapy team judge to be a safety concern for enrollment in the study or that could interfere with the therapeutic process or with other aspects of study participation:
  • A score of ≥7 on the Extended - Hurt, Insult, Threaten, Scream (E-HITS) screening tool
  • A score of "severe" on the Psychological Aggression scale of the Revised Conflict Tactics Inventory (CTS-2)
  • Would present a serious risk to others as established through clinical interview and if necessary, discussion with treating psychiatrist
  • Require ongoing concomitant therapy with a psychiatric medication other than the exceptions described in protocol section on Concomitant Therapy. (PTSD+ veteran)
  • Medical History - PTSD+ veteran only
  • Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate. This includes, but is not limited to, a history of myocardial infarction, cerebrovascular accident, or aneurysm. Participants with other mild, stable chronic medical problems may be enrolled if the study physician and PI agree the condition would not significantly increase the risk of MDMA administration or be likely to produce significant symptoms during the study that could interfere with study participation or be confused with side effects of the IMP. Examples of stable medical conditions that could be allowed include, but are not limited to Diabetes Mellitus (Type 2), Human Immunodeficiency Virus (HIV) infection, Gastroesophageal Reflux Disease (GERD), etc. Any medical disorder judged by the investigator to significantly increase the risk of MDMA administration by any mechanism would require exclusion.
  • Have a diagnosis of uncontrolled hypertension defined by the American Heart Association as repeated readings of ≥ 140 millimeters of Mercury [mmHg] systolic or ≥ 90 mmHg diastolic
  • Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease
  • Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation
  • Have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening. Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled only if they have been successfully treated with ablation and have not had recurrent arrhythmia for at least one year off all antiarrhythmic drugs and confirmed by a cardiologist
  • Have a marked Baseline prolongation of QT/QTc interval. For purposes of eligibility, this is defined as repeated demonstration of a QT interval corrected using Fridericia's formula [QTcF] >450 milliseconds [ms]
  • Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  • Require use of concomitant medications that prolong the QT/QTc interval during Sessions. Refer to protocol section on Concomitant Medications
  • Have symptomatic liver disease or have significant liver enzyme elevations
  • Have history of hyponatremia or hyperthermia
  • Weigh less than 48 kilograms (kg)
  • Are pregnant or nursing or are able to become pregnant and are not able/willing to practice an effective means of birth control
  • Have engaged in ketamine-assisted therapy or used ketamine within 12 weeks of enrollment
  • Have any preexisting conditions that can affect renal functioning

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California, 92161

Other trials in United States

About this study

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.

Read the 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).

Being tested
3,4-methylenedioxymethamphetamine (MDMA), Brief Cognitive Behavioral Conjoint Therapy (bCBCT)
Keywords
PTSD, Intimate relationships, MDMA
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3,4-methylenedioxymethamphetamine (MDMA)Drug

    2 MDMA sessions; PTSD+ Veteran partner only

  • Brief Cognitive Behavioral Conjoint Therapy (bCBCT)Behavioural

    8 bCBCT sessions; Both partners

Study groups in NCT05979844
Study groupRoleWhat they receive
Non-medicine sessions of bCBCT + Medicine Sessions with 3,4-methylenedioxymethamphetamine (MDMA)ExperimentalbCBCT Non-medicine sessions: 8 sessions MDMA Medicine sessions: Initial Dose 1: 80 mg MDMA HCl (~68 mg MDMA) Supplementary Dose 1: 40 mg MDMA HCl (~34 mg MDMA) Initial Dose 2: 100 mg MDMA HCl (~84 mg MDMA) Supplementary Dose 2: 40 mg MDMA HCl (~34 mg MDMA)
Receives: Drug: 3,4-methylenedioxymethamphetamine (MDMA); Behavioral: Brief Cognitive Behavioral Conjoint Therapy (bCBCT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinician-rated PTSD symptoms

    Measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 is a 20-item diagnostic interview that asks about the severity of four PTSD-related symptom clusters: re-experiencing, avoidance, negative alterations in cognition and mood, and alterations in arousal and reactivity. The evaluator rates responses on a 5-point Likert scale (0 = Absent to 4 = Extreme/Incapacitating). Total scores range from 0 to 80 with higher scores indicating greater severity.

    Measured: Baseline - 6 months post-treatment

Secondary outcomes (1)

  1. Relationship satisfaction

    Measured using the Couples Satisfaction Index (CSI-32). The CSI-32 is a 32-item self-report survey that measures romantic relationship satisfaction. The first item measures the overall happiness of the relationship on a 7-point scale (0 = Extremely unhappy to 6 = Perfect). The other 31 items capture satisfaction, quality, and happiness of the relationship on 6-point scales (0 to 5) with varying response options. Total CSI-32 scores range from 0 to 161 with higher scores indicating greater relationship satisfaction. Scores below 104.5 indicate clinical relationship distress.

    Measured: Baseline - 6 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2023
  2. Study start6 Oct 2023
  3. Primary completion14 Nov 2025
  4. Study completion14 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
An open label, single site study assessing the preliminary effectiveness, safety, and acceptability of an intervention consisting of MDMA-assisted bCBCT
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05979844
Sponsor's protocol ID
IVAPT2
Acronym
MDMA-bCBCT
Status last verified
Dec 2025
First submitted
31 Jul 2023
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Morland LA, Perivoliotis D, Wachsman TR, Alam A, Knopp K, Khalifian C, Ramanathan D, Chargin BE, Bismark AW, Glynn S, Stauffer C, Wagner AC. MDMA-assisted brief cognitive behavioral conjoint therapy for PTSD: Study protocol for a pilot study. Contemp Clin Trials Commun. 2024 May 24;40:101314. doi: 10.1016/j.conctc.2024.101314. eCollection 2024 Aug.

    PubMed 38994348

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 3,4-methylenedioxymethamphetamine (MDMA) and Brief Cognitive Behavioral Conjoint Therapy (bCBCT) in people with PTSD and Relational Problems, run by Dr. Leslie Morland at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinician-rated PTSD symptoms (time frame: Baseline - 6 months post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05979844, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

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