Randomized, Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction With Manualized Therapy in 24 Veterans, Firefighters and Police Officers With Chronic Posttraumatic Stress Disorder (PTSD)
Overview
- Phase
- Phase 2
- Intervention
- Therapy
- Conditions
- Posttraumatic Stress Disorder
- Sponsor
- Lykos Therapeutics
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to Primary Endpoint
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective and reducing PTSD symptoms in veterans with chronic PTSD. The main question it aims to answer is: Do three doses of MDMA reduce PTSD symptoms?
Researchers will compare 30, 75, and 125 mg of MDMA HCl with therapy to see which dose best reduces PTSD symptoms.
Participants will undergo three preparatory non-drug therapy sessions with a male and female co-therapist team, then undergo three day-long MDMA-assisted therapy sessions after receiving an initial dose of 30, 75, or 125 mg MDMA HCl. After each MDMA-assisted therapy session, participants will undergo three integrative therapy sessions.
Detailed Description
This study is a randomized, double-blind, dose comparison study with an open-label cross-over segment that will assess the safety and efficacy of MDMA-assisted therapy in veterans with chronic PTSD. Twelve of 24 participants will receive the full dose of 125 mg, six will receive 75 mg and six will receive 30 mg (active placebo dose) of MDMA HCl. An independent rater blind to condition will assess symptoms of PTSD and depression, general quality of life and posttraumatic growth prior to any therapy sessions one month after the second experimental session. After undergoing three 90-minute non-drug introductory therapy sessions with a male/female co-therapist team, study participants will undergo two eight-hour long experimental sessions scheduled three to five weeks apart, prior to which they will be randomized to receive an initial dose of 30, 75 or 125 mg MDMA HCl , followed by a supplemental dose of half the initial dose 1.5 to 2.5 hours later. Participants will undergo integrative therapy in between each experimental session, including on the day after each session. Vital signs and psychological distress will be measured throughout each experimental session, and suicidality will be assessed throughout the course of the study. Spontaneously reported side effects will be collected on the day of each experimental session, and for six days afterward. PTSD symptoms, symptoms of depression, general psychological function, posttraumatic growth and quality of sleep will be assessed one month after the second experimental session, and the blind will be broken. Participants who received 125 mg MDMA HCl will continue to have a third experimental session, and they will be assessed two months after the third experimental session. Participants who received 30 or 75 mg MDMA HCl may take part in an open-label crossover segment that will follow nearly identical procedures, except that there will only be one introductory session prior to the first experimental session. There will be three experimental sessions. Symptoms of PTSD, depression and posttraumatic growth will be assessed at the start of the study. They will also be assessed one month after the second and two months after the third experimental session. All participants will be assessed 12 months after their final experimental session. PTSD and depression symptoms and posttraumatic growth will be assessed, and participants will complete a questionnaire concerning the costs and benefits of being in the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Be diagnosed with chronic PTSD, duration of 6 months or longer resulting from traumatic experience during military service;
- •Have a CAPS score showing moderate to severe PTSD symptoms;
- •Have had at least one unsuccessful attempt at treatment for PTSD either with talk therapy or with drugs, or discontinuing treatment because of inability to tolerate psychotherapy or drug therapy.
- •Are at least 18 years old;
- •Must be generally healthy;
- •Must sign a medical release for the investigators to communicate directly with their therapist and doctors;
- •Are willing to refrain from taking any psychiatric medications during the study period;
- •Willing to follow restrictions and guidelines concerning consumption of food, beverages, and nicotine the night before and just prior to each experimental session;
- •Willing to remain overnight at the study site;
- •Agree to have transportation other than driving themselves home or to where they are staying after the integrative session on the day after the MDMA session;
Exclusion Criteria
- •Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control;
- •Weigh less than 48 kg;
- •Are abusing illegal drugs;
- •Have used ecstasy (material representing itself as MDMA) more than 5 times or at least once in the last 6 months;
- •Are unable to give adequate informed consent;
- •Upon review of past and current drugs/medication must not be on or have taken a medication that is exclusionary;
- •Upon review of medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation.
Arms & Interventions
Low dose MDMA-assisted therapy
Participants will receive 30 mg midomafetamine HCl (MDMA) with therapy during each of two blinded experimental sessions.
Intervention: Therapy
Medium dose MDMA-assisted therapy
Participants will receive 75 mg midomafetamine HCl (MDMA) with therapy on each of two blinded experimental sessions.
Intervention: Therapy
Medium dose MDMA-assisted therapy
Participants will receive 75 mg midomafetamine HCl (MDMA) with therapy on each of two blinded experimental sessions.
Intervention: Medium dose MDMA-assisted therapy
Low dose MDMA-assisted therapy
Participants will receive 30 mg midomafetamine HCl (MDMA) with therapy during each of two blinded experimental sessions.
Intervention: Low dose MDMA-assisted therapy
Full dose MDMA-assisted therapy
Participants will receive 125 mg midomafetamine HCl (MDMA) with therapy during each of two blinded experimental sessions, followed by a third open label session.
Intervention: Full dose MDMA-assisted therapy
Full dose MDMA-assisted therapy
Participants will receive 125 mg midomafetamine HCl (MDMA) with therapy during each of two blinded experimental sessions, followed by a third open label session.
Intervention: Therapy
Outcomes
Primary Outcomes
Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to Primary Endpoint
Time Frame: Baseline to one month after second experimental session
The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. 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.
Secondary Outcomes
- Change in Global Assessment of Function (GAF) From Baseline to Primary Endpoint(Baseline to one month after second experimental session)
- Change in Posttraumatic Growth Inventory (PTGI) From Baseline to Primary Endpoint(Baseline to one month after second experimental session)
- Change in Beck Depression Inventory (BDI-II) From Baseline to Primary Endpoint(Baseline to one month after second experimental session)
- Change in Dissociative Experience Scale (DES-II) From Baseline to Primary Endpoint(Baseline to one month after second experimental session)
- Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Primary Endpoint(Baseline to one month after second experimental session)