MDMA-Assisted CBCT for PTSD vs CBCT RCT
ConditionPost Traumatic Stress Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRemedy
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
MDMA assisted psychotherapy
DrugThis 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.
Psychotherapy
BehavioralA 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: MDMA-Assisted CBCT ConditionExperimental treatment 1 intervention
Group B: CBCT-Only ConditionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
3-Month Follow-up2
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.
Time frame
Baseline (enrolment) to Follow-up (3-month follow-up)3
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).
Time frame
3-month follow-up4
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.
Time frame
3-Month Follow-upSecondary outcomes
1
Posttraumatic Stress Disorder Checklist for the DSM-5 (PCL-5)
PTSD Checklist for the DSM-5 (PCL-5) is a self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms, derived from the DSM-5 symptoms of PTSD. Participants indicate how much distress they have experienced due to symptoms on a five-point Likert-type scale (1 = not at all, 5 = extremely). The total PCL-5 score (a sum of all 20 items) provides an index of overall PTSD symptom severity with higher scores indicating higher severity.
Time frame
Baseline (enrolment) to Follow-up (3-month follow-up)2
Quality of Relationships Inventory (QRI)
The Quality of Relationships Inventory (QRI) is a self-report questionnaire that uses the role of situational, intrapersonal, and interpersonal in social support processes to assess supportive and conflictual aspects of close non-intimate relationships.
Time frame
Baseline (enrolment) to Follow-up (3-month follow-up)3
Couple Satisfaction Index (CSI)
The Couple Satisfaction Index (CSI) is a self-report questionnaire that measures intimate relationship functioning. Respondents answer most of the questions on a six-point Likert-type scale (0= never, 5= all the time) and one question on a seven-point Likert-type scale ( 0= extremely unhappy, 6= perfect).
Time frame
Baseline (enrolment) to Follow-up (3-month follow-up)4
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is used to assess depressive symptom severity. The PHQ-9 includes items which correspond with the diagnostic criteria for DSM-IV major depressive disorder. Scores can indicate either no depression, minimal, mild, moderate, moderately severe, or severe depression. Higher scores indicate higher severity in depressive symptoms.
Time frame
Baseline (enrolment) to Follow-up (3-month follow-up)Other outcomes
1
Posttraumatic Growth Inventory (PTGI)
The Posttraumatic Growth Inventory (PTGI) is a 21-item self-report measure of perceived growth or benefits occurring after a traumatic event. It contains five subscales: relationship to others, new possibilities, personal strength, spiritual change, and appreciation of life.
Time frame
Baseline (enrolment) to Follow-up (3 month follow-up)2
Self-Compassion Scale-Short Form (SCS-SF)
The Self-Compassion Scale-Short Form (SCS-SF) is a 12-item self-report measures that assess self-compassion. This measure is comprised of the following subscales: self-kindness, self-judgement, common humanity, isolation, mindfulness, and over-identification. Respondents answer questions on a five-point Likert-type scale (1= almost never, 5= almost always).
Time frame
Baseline (enrolment) to Follow-up (3-month follow-up)3
Brief Experiential Avoidance Questionnaire (BEAQ)
The Brief Experiential Avoidance Questionnaire (BEAQ) is a 15-item self-report measure that assesses experiential avoidance. Respondents rate the extent to which they agree with each item on a six-point Likert-type scale (1 = strongly disagree, 6= strongly agree).
Time frame
Baseline (enrolment) to Follow-up (3-month follow-up)4
Alcohol Use Disorders Identification Test (AUDIT), Cannabis Use Disorders Identification Test-Revised (CUDIT-R), and Drug Use Disorders Identification Test (DUDIT)
The Alcohol Use Disorders Identification Test (AUDIT), Cannabis Use Disorders Identification Test-Revised (CUDIT-R), and Drug Use Disorders Identification Test (DUDIT) are self-report questionnaires that assess alcohol and substance use.
Time frame
Baseline (enrolment) to Follow-up (3-month follow-up)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Remedy
Lead sponsor
Remedy Institute
Collaborator
Source ClinicalTrials.gov