Overview

This trial is active, not recruiting.

Condition posttraumatic stress disorder
Treatments low dose mdma, medium dose mdma, full dose mdma, psychotherapy
Phase phase 2
Sponsor Multidisciplinary Association for Psychedelic Studies
Start date September 2010
End date October 2016
Trial size 24 participants
Trial identifier NCT01211405, MP-8

Summary

This study is designed to provide information on whether psychotherapy ("talk therapy") combined with the drug MDMA is safe and helpful for subjects with posttraumatic stress disorder (PTSD). The study will compare the effects of a low, a medium and a full dose of MDMA on symptoms of PTSD in 24 veterans, firefighters or police officers. MDMA dose will be assigned at random, and the investigators and the subject will not know the dose given. The researchers will also investigate depression symptoms. The researchers believe that the full dose of MDMA will produce a greater reduction in PTSD symptoms than the two lower doses.

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
(Active Comparator)
Participants will receive 30 mg MDMA during each of two blinded experimental sessions.
low dose mdma MDMA; (
30 mg MDMA administered p.o. once during each experimental session. Upon mutual agreement this maybe followed by a supplemental dose of 15 mg MDMA 1.5 to 2 hours later
psychotherapy
Psychotherapy throughout main study
(Active Comparator)
Participants will receive 75 mg MDMA on each of two blinded experimental sessions
medium dose mdma MDMA;
75 mg MDMA adminis5tered p.o. once at start of an experimental session. Upon mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 37.5 mg
psychotherapy
Psychotherapy throughout main study
(Experimental)
Participants will receive 125 mg MDMA during each of two blinded experimental sessions, followed by a third open label session.
full dose mdma MDMA;
125 mg MDMA administered p.o. at start of an experimental session. By mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 62.5 mg MDMA.
psychotherapy
Psychotherapy throughout main study

Primary Outcomes

Measure
Clinician-Administered PTSD Scale (CAPS)
time frame: Baseline
Clinician-Administered PTSD Scale (CAPS)
time frame: One mo after Experimental Session 2
Clinician-Administered PTSD Scale (CAPS)
time frame: Two months after Experimental Session 3
Clinician-Administered PTSD Scale (CAPS)
time frame: 12 month follow up

Secondary Outcomes

Measure
Global Assessment of Function (GAF)
time frame: Baseline
BDI-II
time frame: Baseline
Posttraumatic Growth Inventory
time frame: Baseline
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Every face to face visit, two of 7 phone contact days, 12 month follow up
Body temperature
time frame: Every 60-90 minutes throughout first 8-h experimental sessionm
Global Assessment of Function (GAF)
time frame: One month after Experimetnal Session 2
Global Assessment of Function (GAF)
time frame: Two months after Experimental Session 3
Global Assessment of Function (GAF)
time frame: 12 month follow up
BDI-II
time frame: One month after Experimental Session 2
BDI-II
time frame: Two months after Experimental Session 3
BDI-II
time frame: 12 month follow up
Posttraumatic Growth Inventory
time frame: One month after Experimental Session 2
Posttraumatic Growth Inventory
time frame: Two months after Experimental Session 3
Posttraumatic Growth Inventory
time frame: 12 month follow up
Peak Body temperature
time frame: Peak value from measurements made every 60-90 minutes throughout second 8-h experimental sessionm
Peak Body temperature
time frame: Peak value from measurements made every 60-90 minutes throughout third 8-h experimental sessionm
Peak blood pressure (systolic)
time frame: Peak value from measuremades made every 15-30 min throughout first eight-hour experimental session
Peak blood pressure (systolic)
time frame: Peak value from measurements made every 15-30 min throughout second eight-hour experimental session
Peak blood pressure (systolic)
time frame: Peak value from measurements made every 15-30 min throughout third eight-hour experimental session
Peak Pulse
time frame: Peak value from measurements made every 15-30 min throughout first eight-hour experimental session
Peak Pulse
time frame: Peak value from measurement made every 15-30 min throughout second eight-hour experimental session
Peak Pulse
time frame: Peak value from measurements made every 15-30 min throughout third eight-hour experimental session
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Baseline
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Session prior to first experimental session
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Twice during first experimental session
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Twice during second experimental session
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Twice during third experimental session
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: 12 month follow up
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: First psychotherapy session after experimental session 1
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Second psychotherapy session after experimental session 1
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Third psychotherapy session after experimental session 1
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: First psychotherapy session after experimental session 2
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Second psychotherapy session after experimental session 2
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Third psychotherapy session after experimental session 2
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: First psychotherapy session after experimental session 3
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Second psychotherapy session after experimental session 3
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Third psychotherapy session after experimental session 3
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Phone contact days 2 and 7 after experimental session 1
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Phone contact days 2 and 7 after experimental session 2
Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Phone contact days 2 and 7 after experimental session 3
Peak Subjective Units of Distress
time frame: Peak value from measurements made every sixty-ninety minutes during experimental session 1
Peak Subjective Units of Distress
time frame: Peak value from measurements made every sixty-ninety minutes during experimental session 2
Peak Subjective Units of Distress
time frame: Peak value from measurements made every sixty-ninety minutes during experimental session 3
Pittsburgh Sleep Quality Index
time frame: Baseline
Pittsburgh Sleep Quality Index
time frame: One month after Experimental Session 2
Pittsburgh Sleep Quality Index
time frame: Two months after Experimental Session 3
States of Consciousness Questionnaire
time frame: After experimental session 1
States of Consciousness Questionnaire
time frame: After experimental session 2
States of Consciousness Questionnaire
time frame: After experimental session 3
Neuroticism Extroversion Openness Inventory (NEO)
time frame: Baseline
Neuroticism Extroversion Openness Inventory (NEO)
time frame: 1 months after Experimental Session 2
Neuroticism Extroversion Openness Inventory (NEO)
time frame: 12 months after Experimental Session 3
Pre-drug body temperature
time frame: Body temperature prior to drug administration during first experimental session
Peak body temperature
time frame: Peak value from measurements made every 60-90 nin during first experimental session
Pre-drug body temperature
time frame: Body temperature prior to drug administration during second experimental session
Pre-drug body temperature
time frame: Body temperature prior to drug administration during third experimental session
Endpoint body temperature
time frame: Body temperature 7 h +/-30 min post drug administration during first experimental session
Endpoint body temperature
time frame: Body temperature 7 h +/- 30 min post drug administration during second experimental session
Endpoint body temperature
time frame: Body temperature 7 h +/- 30 min post drug administration during third experimental session
Pre-drug Pulse
time frame: Pre-drug value at first eight-hour experimental session
Endpoint Pulse
time frame: Pulse 7 h +/- 30 min post drug on first 8-hour experimental session
Pre-drug Pulse
time frame: Pre-drug pulse on second eight-hour experimental session
Endpoint Pulse
time frame: Pulse 7 h +/- 30 min post-drug on second eight-hour experimental session
Pre-drug Pulse
time frame: Pre-drug pulse on the third eight-hour experimental session
Endpoint Pulse
time frame: Pulse 7 h +/- 30 min post-drug on third eight-hour experimental session
Peak blood pressure (diastolic)
time frame: Peak value from measuremades made every 15-30 min throughout first eight-hour experimental session
Peak lood pressure (diastolic)
time frame: Peak value from measurements made every 15-30 min throughout second eight-hour experimental session
Peak blood pressure (diastolic)
time frame: Peak value from measurements made every 15-30 min throughout third eight-hour experimental session
Pre-drug blood pressure
time frame: Prior to drug administration on first experimental session
Endpoint blood pressure
time frame: Value at 7 h +/- 30 min post-drug on first 8-hour experimental session
Pre-drug blood pressure
time frame: Value prior to drug administration on second experimental session
Endpoint blood pressure
time frame: Value 7 h +/- 30 min post-drug on second 8-hour ecxperimental session
Pre-drug blood pressure
time frame: Value prior to drug administration on third experimental session
Endpoint blood pressure
time frame: Value 7 h +/- 30 min post-drug on third 8-hour experimental session

Eligibility Criteria

Male or female participants at least 18 years old.

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; - 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; - Must provide a contact in the event of a participant becoming suicidal; - Are proficient in speaking and reading English; - Agree to have all clinic visit sessions recorded to audio and video - Agree not to participate in any other interventional clinical trials during the duration of this study. Exclusion Criteria: 5.3.2 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 s

Additional Information

Official title Randomized, Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction With Manualized Psychotherapy in 24 Veterans, Firefighters and Police Officers With Chronic Posttraumatic Stress Disorder (PTSD)
Principal investigator Michael C Mithoefer, MD
Description Posttraumatic stress disorder (PTSD) is a debilitating mental disorder, that can develop after service in the armed forces. Psychotherapy performed along with MDMA is an innovative form of therapy for posttraumatic stress disorder. This study will follow on the findings of an initial pilot study in a sample largely made up of people whose PTSD did not develop from serving in the military. This study will investigate whether MDMA-assisted psychotherapy is safe and efficacious in a sample of veterans and whether maintaining an effective double-blind can be better addressed by performing a dose comparison study. 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 psychotherapy in veterans with chronic posttraumatic stress disorder. 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). An independent rater blind to condition will assess symptoms of PTSD and depression, general quality of life and posttraumatic growth prior to any psychotherapy sessions one month after the second experimental session. After undergoing three 90-minute non-drug introductory psychotherapy sessions with a male/female co-therapist team, study participants will undergo two eight-hour long experimental sessions scheduled three to five weeks apart, during which they will randomly receive either 30, 75 or 125 mg MDMA on both occasions, followed by a supplemental dose of half the initial dose. Participants will undergo integrative psychotherapy 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 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 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Multidisciplinary Association for Psychedelic Studies.