Overview

This trial is active, not recruiting.

Condition posttraumatic stress disorder (ptsd)
Treatments active placebo dose mdma, full dose mdma, 125 mg mdma (open label)
Phase phase 2
Sponsor Multidisciplinary Association for Psychedelic Studies
Start date October 2013
End date March 2017
Trial size 10 participants
Trial identifier NCT01689740, MP-9

Summary

This study will examine symptoms of posttraumatic stress disorder (PTSD) in people before and after psychotherapy with 25 mg followed two hours later by 12.5 mg or 125 mg followed two hours later by 62.5 mg methylenedioxymethamphetamine (MDMA) in order to see if this treatment is safe and can help reduce PTSD symptoms. Participants will be randomly assigned to one of the two doses of MDMA given in two sessions scheduled three to five weeks apart. They will prepare for the sessions before the first one and they will work with psychotherapists in conventional (non-drug assisted) psychotherapy afterwards. Symptoms of PTSD and depression, sleep quality and general psychological health will be measured at the start of the study and 2 and 12 months after the second session.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants receive initial dose of 125 mg MDMA possibly followed by a supplemental dose of 62.5 mg during two psychotherapy sessions scheduled 3-5 weeks apart. This arm is open label.
125 mg mdma (open label)
Initial dose of MDMA administered orally at the start of each of two psychotherapy sessions, supplement administered 1.5 go 2.5 hours later.
(Placebo Comparator)
Participants receive initial doses of 25 mg MDMA during each of two experimental sessions.
active placebo dose mdma
Initial dose of 25 mg MDMA administered orally at the start of each of two separate psychotherapy sessions scheduled three to five weeks apart possibly followed by a supplemental dose of 12.5 mg MDMA 1.5 to 2.5 hours later.
(Experimental)
Participant will receive full dose MDMA (125 mg NDMA( during two separate psychotherapy sessions.
full dose mdma
Initial dose of 125 mg MDMA administered orally at the start of each of two psychotherapy sessions scheduled three to five weeks apart. In each case, it may be followed 1.5 to 2.5 hours later with 62.5 mg MDMA.

Primary Outcomes

Measure
Clinician Administered PTSD Scale (CAPS)
time frame: 14-19 weeks post enrollment)
Clinician Administered PTSD Scale (CAPS)
time frame: 0 weeks post-enrollment

Secondary Outcomes

Measure
Clinician-Administered PTSD Scale
time frame: 24 to 35 weeks post-enrollment
Clinician-Administered PTSD Scale
time frame: Up to 64 weeks post-enrollment
Beck Depression Inventory - II
time frame: 14-19 weeks post-enrollment
Beck Depression Inventory - II
time frame: 0 weeks post-enrollment
Beck Depression Inventory - II
time frame: 24 to 35 weeks post-enrollment
Beck Depression Inventory - II
time frame: Up to 64 weeks post-enrollment
Global Assessment of Functioning (GAF)
time frame: 14-19 weeks post-enrollment
Global Assessment of Functioning (GAF)
time frame: 0 week post-enrollment
Global Assessment of Functioning (GAF)
time frame: 24 to 35 weeks post-enrollment
Global Assessment of Functioning (GAF)
time frame: Up to 64 weeks post-enrollment
Pittsburgh Sleep Quality Index
time frame: 0 weeks post-enrollment
Pittsburgh Sleep Quality Index
time frame: 14-19 weeks post-enrollment
Pittsburgh Sleep Quality Index
time frame: Up to 64 weeks post-enrollment
Posttraumatic Diagnostic Scale (PDS)
time frame: 0 weeks post-enrollment
Posttraumatic Diagnostic Scale (PDS)
time frame: 5-8 weeks post-enrollment
Posttraumatic Diagnostic Scale (PDS)
time frame: 8-13 weeks post-enrollment
Posttraumatic Diagnostic Scale (PDS)
time frame: 14-19 weeks post-enrollment
Posttraumatic Diagnostic Scale (PDS)
time frame: Up to 64 weeks post-enrollment
Peak Systolic blood pressure
time frame: 3-6 weeks post-enrollment: collected from measurements made every 30 min for 6-8 hours
Peak Systolic blood pressure
time frame: 6-11 weeks post-enrollment: collected from measurements made every 30 min for 6-8 hours
Peak diastolic blood pressure
time frame: 3-6 weeks post-enrollment: from measurements taken every 30 min for 6-8 hours
Peak diastolic blood pressure
time frame: 6-11 weeks post-enrollment: from measurements taken every 30 min for 6-8 hours
Peak heart rate (HR)
time frame: 3-6 weeks post enrollment; from measurements taken every 30 minutes for 6-8 hours
Peak heart rate (HR)
time frame: 6-11 weeks post-enrollment: from measurements taken every 30 minutes for 6-8 hours
Peak body temperature
time frame: 3-6 weeks post-enrollment; from measurements taken every 60-90 min throughout session
Peak body temperature
time frame: 6-11 weeks post-enrollment; from measurements taken every 60-90 min throughout session
Peak subjective units of distress (SUD)
time frame: 3-6 weeks post-enrollment; from measurements taken every 60-90 min throughout session
Peak subjective units of distress (SUD)
time frame: 6-11 weeks post-enrollment; from measurements taken every 60-90 min throughout session
End-point systolic blood pressure
time frame: 3-6 weeks post-enrollment; last measurement
End-point systolic blood pressure
time frame: 6-11 weeks post-enrollment; last measurement
End-point diastolic blood pressure
time frame: 3-6 weeks post-enrollment; last measurement
End-point diastolic blood pressure
time frame: 6-11 weeks post-enrollment; last measurement
End-point heart rate (HR)
time frame: 3-6 weeks post-enrollment; last measurement
End-point heart rate (HR)
time frame: 6-11 weeks post-enrollment; last measurement
End-point body temperature
time frame: 3-6 weeks post-enrollment; last measurement
End-point body temperature
time frame: 6-11 weeks post-enrollment; last measurement
End-point Subjective Units of Distress (SUD)
time frame: 3-6 weeks post-enrollment; last measurement
End-point Subjective Units of Distress (SUD)
time frame: 6-11 weeks post-enrollment; last measurement
Pre-drug systolic blood pressure
time frame: 3-6 weeks post-enrollment; first measurement taken prior to drug administration
Pre-drug systolic blood pressure
time frame: 6-11 weeks post-enrollment; first measurement taken prior to drug administration
Pre-drug diastolic blood pressure
time frame: 3-6 weeks post-enrollment; first measurement taken prior to drug administration
Pre-drug diastolic blood pressure
time frame: 6-11 weeks post-enrollment; first measurement taken prior to drug administration
Columbia Suicide Severity Rating Scale (CSSRS)
time frame: 0 weeks post-enrollment
Pre-drug heart rate
time frame: 3-6 weeks post-enrollment: collected prior to drug administration
Pre-drug heart rate
time frame: 6-11 weeks post-enrollment; first measurement taken prior to drug administration
Pre-drug body temperature
time frame: 3-6 weeks post-enrollment; first measurement taken prior to drug administration
Pre-drug body temperature
time frame: 6-11 weeks post-enrollment; first measurement taken prior to drug administration
Pre-drug Subjective Units of Distress (SUD)
time frame: 3-6 weeks post-enrollment; last measurement
Pre-drug Subjective Units of Distress (SUD)
time frame: 6-11 weeks post-enrollment; last measurement
Columbia Suicide Severity Rating Scale (CSSRS)
time frame: 2 weeks post-enrollment
Columbia Suicide Severity Rating Scale (CSSRS)
time frame: 3-6 weeks post-enrollment (session start/approx. 6 hours postdrug)
Columbia Suicide Severity Rating Scale (CSSRS)
time frame: 6-11 weeks post-enrollment (session start/approx. 6 hours postdrug)
Columbia Suicide Severity Rating Scale (CSSRS)
time frame: Up to 64 weeks post-enrollment
Columbia Suicide Severity Rating Scale (CSSRS)
time frame: 3 weeks +1 day to 6 weeks + 1 day post-enrollment
Columbia Suicide Severity Rating Scale (CSSRS)
time frame: 6 weeks +1 day to 11 weeks + 1 day post-enrollment
Columbia Suicide Severity Rating Scale (CSSRS)
time frame: 4-7 weeks post-enrollment
Columbia Suicide Severity Rating Scale (CSSRS)
time frame: 5-8 weeks post-enrollment
Columbia Suicide Severity Rating Scale (CSSRS)
time frame: 7-12 weeks post-enrollment
Columbia Suicide Severity Rating Scale (CSSRS)
time frame: 8-13 weeks post-enrollment
Columbia Suicide Severity Rating Scale (CSSRS)
time frame: 3 weeks +3 and 8 days to 6 weeks +3 and 8 days post-enrollment
Columbia Suicide Severity Rating Scale (CSSRS)
time frame: 6 weeks +3 and 8 days to 11 weeks +3 and 8 days post-enrollment
Columbia Suicide Severity Rating Scale (CSSRS)
time frame: 14-19 weeks post-enrollment

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosed with chronic PTSD with a duration of 6 months or longer; - Have a CAPS score showing moderate to severe symptoms - at least one unsuccessful attempt at treatment for PTSD either with talk therapy or with drugs, or stopping treatment because of inability to tolerate psychotherapy or drug therapy. - Are at least 18 years old - 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 - agree that, one week before the MDMA session, will refrain from taking all below unless with prior approval of research team: herbal supplements, nonprescription medications (with the exception of nonsteroidal anti-inflammatory drugs or acetaminophen,any prescription medications, with the exception of birth control pills, thyroid hormone, or other medications; - Willing to follow restrictions and guidelines concerning consumption of food, beverages, and nicotine the night before and just prior to each experimental session - are willing to remain overnight at the study site - are willing to be contacted via telephone for all necessary telephone contacts; - must have a negative pregnancy test if able to bear children, and agree to use an effective form of birth control; - Agree not to participate in any other clinical trial for the duration of this clinical trial, including the follow up period; - Are proficient in speaking and reading Hebrew; - Agree to have all psychotherapy sessions recorded to audio/video. 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; - 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 in the study

Additional Information

Official title A Randomized, Double-Blind, Active Placebo-Controlled Phase 2 Pilot Study of MDMA-assisted Psychotherapy in People With Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)
Principal investigator Moshe Kotler
Description Posttraumatic stress disorder (PTSD) is a debilitating disorder that develops after people undergo a traumatic event, such as a rape, car accident or other life-threatening event. PTSD is a worldwide health problem. Psychotherapy or drugs are used to treat PTSD, but there is an interest in developing other treatment options. 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy is one potential treatment. MDMA is known as the active ingredient in "ecstasy." It was used along with psychotherapy to treat people in the past, and a study suggests that MDMA-assisted psychotherapy might help people with PTSD. This Phase 2 research study will investigate the safety and efficacy of MDMA-assisted psychotherapy in 10 people with chronic, treatment-resistant posttraumatic stress disorder (PTSD). After open-label lead-in in two subjects there will be a randomized, double-blind arm comparing 125 vs. 25 mg MDMA in eight participants, and an open-label arm for participants who received active placebo. In this study, five people will be randomly assigned to receive the full dose of 125 and 62.5 mg MDMA and three will be randomized to receive the active placebo dose of 25 and 125. mg MDMA. MDMA will be administered during two six to eight hour long experimental sessions scheduled three to five weeks apart. Study subjects will have a medical and psychiatric examination and a measure of their PTSD symptoms to make sure they meet the criteria to be in the study. Subjects must be in good physical health. They will also complete questionnaires about their PTSD symptoms, symptoms of depression and sleep quality. These tests will be given by a researcher who will not be present during any of the therapy sessions. This same researcher will give the subject the same tests or measures two months after the second experimental session and 12 months after a final experimental session. Once enrolled, subjects will have three preparatory sessions with a team of two therapists, one male and one female. The same team of therapists will work with them throughout the entire study. The subject will learn more about MDMA-assisted psychotherapy and the therapists will learn more about the subject's goals, hopes and fears. Starting from the second preparatory session, subjects will answer questions on thoughts about hurting or killing themselves; these questions will be asked during face to face contact this and on two of the contact days, which may occur over the telephone. Subjects will have to stop taking their psychiatric medication before they have their first experimental session, with exact times dependent upon the specific medications involved. Both therapists will be present for each experimental session. During experimental sessions, subjects will be encouraged to confront trauma-related thoughts, feelings and memories. Blood pressure, heart rate (pulse) and body temperature will be measured regularly, and the researchers will periodically ask the subject to rate his or her degree of distress. Subjects will stay overnight at the clinic and have their first integrative session, where they will examine what happened during their experimental session. They will have two more integrative sessions until they have their next experimental session. Subjects will fill out a questionnaire on their PTSD symptoms on every third integrative session. Two months after the second experimental session, subjects will answer questions or complete questionnaires about PTSD symptoms, symptoms of depression and sleep quality, and one of the researchers will assess their general psychological function. Subjects and the therapists, but not the person measuring symptoms, will find out if the subject had the active placebo or full dose of MDMA at this time, and if the subject had the active placebo, they can start the second arm of the study. What happens during this arm is very similar to the arm except that the subject and therapists will know the subject is getting a full dose of MDMA. Twelve months after the subject's final follow-up visit (two months after their final experimental session), PTSD symptoms, symptoms of depression and sleep quality will be assessed again, and subjects will complete an additional questionnaire about their experiences during and after the study. The study will compare PTSD symptoms before and after MDMA-assisted psychotherapy with a full dose and therapy with an active placebo dose of MDMA.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Multidisciplinary Association for Psychedelic Studies.