MDMA-Assisted CBCT for PTSD vs CBCT RCT

NCT06044675 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ICAPT1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the safety, feasibility, acceptability, and effectiveness of MDMA-assisted Cognitive-Behavioral Conjoint Therapy (CBCT) versus CBCT alone for the treatment of Post-Traumatic Stress Disorder (PTSD). PTSD is a debilitating condition that significantly impacts interpersonal relationships and the functioning of individuals and their loved ones. There is also a well-established reciprocal relationship between interpersonal relationships, PTSD, and recovery. CBCT is a manualized treatment for PTSD that simultaneously addresses PTSD symptoms and relationship satisfaction. It provides dyads with behavioral tools to navigate PTSD-related challenges, as well as the knowledge behind PTSD and how it impacts relationships. Previous research has demonstrated the efficacy of CBCT in improving PTSD symptoms, partner functioning, and relationship satisfaction in both distressed and non-distressed dyads. MDMA is a drug commonly used recreationally that has been increasingly studied because of its ability to reduce the impact of PTSD symptoms. The effects of MDMA are reduced fear, enhanced communication, trust and introspection, and increased empathy and compassion. The effects of MDMA create a state that enhances the positive effects of therapy by increasing the ability to tolerate negative emotions and allowing clients to stay engaged in therapy without being overwhelmed by the intense emotions surrounding the memories of traumatic events. It is believed that MDMA may help promote the effects of CBCT due to its ability to induce empathy and interpersonal openness. This randomized study is the second study designed to explore the efficacy of combining MDMA-assisted therapy with CBCT. This study will enroll 30 dyads, where one individual has symptoms of PTSD. Participants will undergo a 7-week psychotherapy course, in MDMA-assisted CBCT or CBCT alone. In the MDMA-assisted CBCT, participants will go through CBCT sessions, and two doses of MDMA will be used as an adjunct to psychotherapy. Participants assigned to the CBCT-only condition will go through CBCT sessions and will have the opportunity to crossover and receive the two MDMA sessions after follow-up. The primary goal of this research is to contribute to the literature on MDMA-assisted CBCT by investigating its feasibility, safety, acceptability, and effectiveness, and by comparing it to active PTSD treatments.

Conditions

Post Traumatic Stress Disorder

Keywords

MDMA; Cognitive Behavioural Conjoint Therapy (CBCT); Relationship functioning

Outcome Measures

Primary Outcomes (5)

• Feasibility of Intervention Measure (FIM)

  The Feasibility of Intervention Measure (FIM) is a self-report questionnaire in which respondents indicate the extent to which they believe that the treatment can be delivered in a given setting. Respondents indicate their responses on a five-point Likert-type (1=completely disagree, 5= completely agree).

  3-Month Follow-up

• Safety of Intervention

  Safety will be assessed by examining the frequency and severity of adverse events (AEs), serious AEs (SAEs), treatment emergent AES (TEAEs), and AEs of special interest. Participants are asked to report any AEs, SAEs, TEAEs, and AEs of special interest as they happen and during any communication with the therapist or independent assessor.

  Baseline (enrolment) to Follow-up (3-month follow-up)

• Intervention Appropriateness Measures (IAM)

  Intervention Appropriateness Measures (IAM) is a self-report measure of the perceived fit, relevance, or compatibility of an intervention. Respondents record their answers on a five-point Likert-type scale (1=completely disagree, 5= completely agree).

  3-month follow-up

• Long Term Follow-Up Questionnaire (LTFUQ)

  The Long Term Follow-Up Questionnaire (LTFUQ) is a self-report measure that assesses the long-term benefits and harms of MDMA-assisted therapy.

  3-Month Follow-up

• Clinician Administered PTSD Scale (CAPS-5)

  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 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 (enrolment) to Follow-up (3-month follow-up)

Secondary Outcomes (4)

• Posttraumatic Stress Disorder Checklist for the DSM-5 (PCL-5)

  Baseline (enrolment) to Follow-up (3-month follow-up)

• Quality of Relationships Inventory (QRI)

  Baseline (enrolment) to Follow-up (3-month follow-up)

• Couple Satisfaction Index (CSI)

  Baseline (enrolment) to Follow-up (3-month follow-up)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline (enrolment) to Follow-up (3-month follow-up)

Other Outcomes (13)

• Posttraumatic Growth Inventory (PTGI)

  Baseline (enrolment) to Follow-up (3 month follow-up)

• Self-Compassion Scale-Short Form (SCS-SF)

  Baseline (enrolment) to Follow-up (3-month follow-up)

• Brief Experiential Avoidance Questionnaire (BEAQ)

  Baseline (enrolment) to Follow-up (3-month follow-up)

Study Arms (2)

MDMA-Assisted CBCT Condition

EXPERIMENTAL

Dyads will undergo a 7-week course of CBCT psychotherapy for PTSD with two sessions that integrate MDMA-assisted psychotherapy. MDMA will be administered in two separate sessions and integrated into the psychotherapy protocol. The two doses of MDMA during this study will be used as an adjunct to psychotherapy.

Drug: MDMA assisted psychotherapy

CBCT-Only Condition

ACTIVE COMPARATOR

Dyads will undergo a 7-week course of CBCT psychotherapy for PTSD. Dyads who have undergone the CBCT-Only condition will have the option to do a crossover and have the two MDMA sessions after follow-up.

Behavioral: Psychotherapy

Interventions

MDMA assisted psychotherapy DRUG

This treatment combines MDMA with a well researched treatment for PTSD for dyads known as CBCT. Dyads will undergo a 7-week course of psychotherapy with two doses of MDMA will be used as an adjunct to psychotherapy.

Also known as: MDMA-assisted CBCT

MDMA-Assisted CBCT Condition

Psychotherapy BEHAVIORAL

A manualized treatment for PTSD for dyads wherein one person has symptoms of PTSD. This intervention is 7-week course of psychotherapy that is designed to simultaneously improve PTSD symptoms and relationship functioning through education and skill training.

Also known as: CBCT

CBCT-Only Condition

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant with PTSD
• Participant with PTSD
• Meet criteria for PTSD
• Have a close other person who is able and willing to participate in this study
• Are at least 18 years old
• Are a resident of Ontario and live within the Greater Toronto Area (GTA)
• Are in good physical health
• Are proficient in speaking and reading English
• Are willing to have all visits audio and video recorded
• Are able to swallow pills
• Agree to all study rules and commit to all medical and therapy visits
• If in psychotherapy, are willing to allow the study therapists to communicate directly with your therapist
• Are willing to stop taking psychiatric medications, herbal supplements, prescription and nonprescription medications during the study
• Agree to stay overnight on two separate occasions after each full-day MDMA-Assisted Therapy Session, and not to drive for at least 24 hours after taking MDMA
• Are not pregnant and will commit to not becoming pregnant during the study, if you are able to become pregnant

You may not qualify if:

• Participant with PTSD
• Are pregnant or could become pregnant and not using birth control
• Have a history of, or a current psychotic disorder or bipolar 1 disorder or dissociative identity disorder
• Have a history of a medical condition that could make receiving MDMA unsafe (e.g. glaucoma, heart attack, stroke, aneurysm)
• Have a history of Diabetes Mellitus (Type 2) that a doctor determines is not stable
• Have hypothyroidism (low activity in the thyroid gland) and are not on thyroid replacement
• Have high blood pressure, a history of heart disease, heart failure, irregular activity in the heart or require heart medication
• Have liver disease with symptoms
• Have history of hyponatremia (when you have decreased levels of sodium in the blood, which can cause confusion, seizures, fatigue and low levels of consciousness)
• Have history of hyperthermia (when you have a dangerously overheated body, usually in response to hot, humid weather)
• Weigh less than 48 kg
• Have recently engaged in suicidal behaviour or had serious suicidal thoughts (this will be assessed by the study team)
• Require ongoing therapy with a psychiatric medication
• Have a current eating disorder with active purging
• Have current major depressive disorder with psychotic features

Sponsors & Collaborators

• Remedy: lead
• Remedy Institute: collaborator

Study Sites (1)

Remedy Institute

Toronto, Ontario, M6G 1L5, Canada

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Paul Uy, MD

  Remedy Institute

  PRINCIPAL INVESTIGATOR

• Anne Wagner, PhD

  Remedy Institute

  STUDY CHAIR

Central Study Contacts

Song Ge

CONTACT

4372914747; research@remedyinstitute.ca

Anne Wagner, C.Psych.

CONTACT

647-362-8822; dr.wagner@remedyinstitute.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: November 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)