MDMA-assisted Brief Cognitive Behavioral Conjoint Therapy for PTSD
Overview
- Phase
- Phase 3
- Intervention
- 3,4-methylenedioxymethamphetamine (MDMA)
- Conditions
- PTSD
- Sponsor
- Dr. Leslie Morland
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Clinician-rated PTSD symptoms
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief 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).
Investigators
Dr. Leslie Morland
Dr. Leslie Morland
San Diego Veterans Healthcare System
Eligibility Criteria
Inclusion Criteria
- •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.
- •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)
Exclusion Criteria
- •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)
- •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)
Arms & Interventions
Non-medicine sessions of bCBCT + Medicine Sessions with 3,4-methylenedioxymethamphetamine (MDMA)
bCBCT 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)
Intervention: 3,4-methylenedioxymethamphetamine (MDMA)
Non-medicine sessions of bCBCT + Medicine Sessions with 3,4-methylenedioxymethamphetamine (MDMA)
bCBCT 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)
Intervention: Brief Cognitive Behavioral Conjoint Therapy (bCBCT)
Outcomes
Primary Outcomes
Clinician-rated PTSD symptoms
Time Frame: Baseline - 6 months post-treatment
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.
Secondary Outcomes
- Relationship satisfaction(Baseline - 6 months post-treatment)