Overview

This trial is active, not recruiting.

Condition posttraumatic stress disorder
Treatments comparator-dose mdma, active dose 1 mdma, active dose 2 mdma
Phase phase 2
Sponsor Multidisciplinary Association for Psychedelic Studies
Start date April 2013
End date December 2015
Trial size 23 participants
Trial identifier NCT01793610, MP-12

Summary

This small ("pilot") study is designed to provide information on whether psychotherapy combined with the drug MDMA is safe and helpful for people with posttraumatic stress disorder (PTSD). The researchers plan to use the results of this study to design further studies. This study will compare two doses of MDMA active dose 1, two doses of MDMA active dose 2, or comparator-dose MDMA. There will be an initial dose possibly followed one and a half to two and a half hours later by a second dose half the size of the first dose. The study will measure symptoms of PTSD, depression, general psychological well-being and sleep after a low dose versus active doses of MDMA. Subjects experiencing pain or tinnitus (ringing in the ears) at the start of the study will report on levels of pain or tinnitus during the study. The study will also examine whether following the standardized treatment is related to changes in PTSD symptoms. Subjects will be prepared for MDMA-assisted psychotherapy prior to the first session, and he or she will work with the same pair of therapists after having two MDMA-assisted psychotherapy sessions, with the second session occurring three to five weeks after the first session. Symptoms of PTSD, depression, general psychological well-being, feeling that you or the world are unreal (dissociation), potential positive effects of traumatic events and sleep quality will be assessed one month after the second MDMA-assisted session. Cognitive function will be measured one month after the second MDMA-assisted session. Participants who received comparator-dose MDMA can enroll in Stage 2, wherein they will have three MDMA-assisted psychotherapy sessions. People who received either active-dose MDMA will have a third MDMA-assisted session. Cognitive function will be measured again after two months last Stage 1 or Stage 2 MDMA-assisted session.Subject PTSD symptoms, depression psychological symptoms, other symptoms and sleep two months after their final MDMA-assisted session and at least 12 months after they began the study.

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 receive initial doses of comparator-dose MDMA during each of two experimental sessions.
comparator-dose mdma 3,4-methylenedioxymethamphetamine
Initial comparator-dose MDMA orally at the start of two separate psychotherapy sessions scheduled 3 to 5 weeks apart, with the initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose half the size of the initial dose MDMA.
(Experimental)
Participants receive and initial dose of Active Dose 1 MDMA during each of two experimental sessions.
active dose 1 mdma 3,4-methylenedioxymethamphetamine
An initial dose of full-dose MDMA orally given at the start of each of two psychotherapy sessions and possibly followed a dose half the size of the initial dose of MDMA 1.5 to 2.5 hours later.
(Experimental)
Participants receive and initial dose of Active Dose 2 MDMA during each of two experimental sessions.
active dose 2 mdma 3,4-methylenedioxymethamphetamine

Primary Outcomes

Measure
Clinician Administered PTSD Scale
time frame: 3 months after enrollment

Secondary Outcomes

Measure
Clinician Administered PTSD Scale
time frame: 0 months post-enrollment
Average peak systolic blood pressure
time frame: One and two months after enrollment
Average peak diastolic blood pressure
time frame: One and two months after enrollment
Average peak heart rate
time frame: One and two months after enrollment
Average peak body temperature
time frame: One and two months after enrollment
Average pre-drug systolic blood pressure
time frame: One and two months after enrollment
Average pre-drug diastolic blood pressure
time frame: One and two months after enrollment
Average pre-drug heart rate
time frame: One and two months after enrollment
Average pre-drug body temperature
time frame: One and two months after enrollment
Average final post-drug systolic blood pressure
time frame: One and two months after enrollment
Average final post-drug diastolic blood pressure
time frame: One and two weeks after enrollment
Average final post-drug heart rate
time frame: One and two months after enrollment
Average final post-drug body temperature
time frame: One and two months after enrollment
Average peak Subjective Units of Distress (SUD)
time frame: One and two months after enrollment
Average pre-drug SUD
time frame: One and two months after enrollment
Average final post-drug SUD
time frame: One and two months after enrollment
Clinician Administered PTSD Scale
time frame: 5 months post-enrollment
Clinician Administered PTSD Scale
time frame: 15-18 months post-enrollment
Clinician Administered PTSD Scale
time frame: 5 months post-enrollment
Clinician Administered PTSD Scale
time frame: 7 months post-enrollment
Global Assessment of functioning
time frame: 0 months post-enrollment
Global Assessment of functioning
time frame: 3 months post-enrollment
Global Assessment of functioning
time frame: 15-18 months post-enrollment
Global Assessment of functioning
time frame: 5 months post-enrollment
Global Assessment of functioning
time frame: 5 months post-enrollment
Global Assessment of functioning
time frame: 7 months post-enrollment
Beck Depression Inventory II`
time frame: 0 months post-enrollment
Beck Depression Inventory II`
time frame: 3 months post-enrollment
Beck Depression Inventory II`
time frame: 5 months post-enrollment
Beck Depression Inventory II`
time frame: 15-18 months post-enrollment
Beck Depression Inventory II`
time frame: 5 months post-enrollment
Beck Depression Inventory II`
time frame: 7 months post-enrollment
Pittsburgh Sleep Quality Index (PSQI)
time frame: 0 months post-enrollment
Pittsburgh Sleep Quality Index (PSQI)
time frame: 3 months post-enrollment
Pittsburgh Sleep Quality Index (PSQI)
time frame: 15-18 months post-enrollment
Pittsburgh Sleep Quality Index (PSQI)
time frame: 5 months post-enrollment
Pittsburgh Sleep Quality Index (PSQI)
time frame: 5 months post-enrollment
Pittsburgh Sleep Quality Index (PSQI)
time frame: 7 months post-enrollment
Posttraumatic Diagnostic Scale (PDS)
time frame: 0 months post-enrollment
Posttraumatic Diagnostic Scale (PDS)
time frame: 3 months post-enrollment
Posttraumatic Diagnostic Scale (PDS)
time frame: 15-18 months post-enrollment
Posttraumatic Diagnostic Scale (PDS)
time frame: 5 months post-enrollment
Posttraumatic Diagnostic Scale (PDS)
time frame: 5 months post-enrollment
Posttraumatic Diagnostic Scale (PDS)
time frame: 1.5 months post-enrollment
Posttraumatic Diagnostic Scale (PDS)
time frame: 2.5 months post-enrollment
Posttraumatic Diagnostic Scale (PDS)
time frame: 3.5 months post-enrollment
Posttraumatic Diagnostic Scale (PDS)
time frame: 3.5 months post-enrollment
Posttraumatic Diagnostic Scale (PDS)
time frame: 4 months post-enrollment
Posttraumatic Diagnostic Scale (PDS)
time frame: 4.5 months post-enrollment
Posttraumatic Diagnostic Scale (PDS)
time frame: 7 months post-enrollment
States of Consciousness Questionnaire (SOCQ)
time frame: One month post enrollment
States of Consciousness Questionnaire (SOCQ)
time frame: Two months post enrollment
States of Consciousness Questionnaire (SOCQ)
time frame: 3 months post enrollment
States of Consciousness Questionnaire (SOCQ)
time frame: 3.5 months post enrollment
States of Consciousness Questionnaire (SOCQ)
time frame: 4.5 months post enrollment
States of Consciousness Questionnaire (SOCQ)
time frame: 4.5 months post enrollment
Columbia Suicide Severity Rating Scale
time frame: 0 months post-enrollment
Columbia Suicide Severity Rating Scale
time frame: Up to 0.75 month post-enrollment
Average Columbia Suicide Severity Rating Scale
time frame: 1 to 3 months post-enrollment
Peak Columbia Suicide Severity Rating Scale
time frame: 1 to 3 months post-enrollment
Average Columbia Suicide Severity Rating Scale
time frame: 3 to 6 months post-enrollment
Peak Columbia Suicide Severity Rating Scale
time frame: 3 to 6 months post-enrollment
Peak Columbia Suicide Severity Rating Scale
time frame: 15 to 18 months post-enrollment
Dissociative Experiences Scale II
time frame: 0 months post-enrollment
Dissociative Experiences Scale II
time frame: 3 months post-enrollment
Dissociative Experiences Scale II
time frame: 5 months post-enrollment
Dissociative Experiences Scale II
time frame: 15-18 months post-enrollment
Dissociative Experiences Scale II
time frame: 5 months post-enrollment
Dissociative Experiences Scale II
time frame: 7 months post-enrollment
Pain and tinnitus visual analog scales
time frame: 0 months after enrollment
Pain and tinnitus visual analog scales
time frame: 5 months after enrollment
Repeatable Battery for the Assessment of Neuropsychological Status Total score
time frame: 0 months post-enrollment
Repeatable Battery for the Assessment of Neuropsychological Status Total score
time frame: 3 months post study enrollment
Repeatable Battery for the Assessment of Neuropsychological Status Total score
time frame: 5 or 7 months post study enrollment
Paced Auditory Serial Addition Test Correct 3 seconds
time frame: 0 months post-enrollment
Paced Auditory Serial Addition Test Correct 3 seconds centile
time frame: 0 months post-enrollment
Paced Auditory Serial Addition Test Correct 2 seconds
time frame: 0 months post-enrollment
Paced Auditory Serial Addition Test Correct 2 seconds centile
time frame: 0 months post-enrollment
Paced Auditory Serial Addition Test Correct 3 seconds
time frame: 3 months post-enrollment
Paced Auditory Serial Addition Test Correct 3 seconds centile
time frame: 3 months post-enrollment
Paced Auditory Serial Addition Test Correct 2 seconds
time frame: 3 months post-enrollment
Paced Auditory Serial Addition Test Correct 2 seconds centile
time frame: 3 months post-enrollment
Paced Auditory Serial Addition Test Correct 3 seconds
time frame: 5 months or 7 months post-enrollment
Paced Auditory Serial Addition Test Correct 3 seconds centile
time frame: 5 months or 7 months post-enrollment
Paced Auditory Serial Addition Test Correct 2 seconds
time frame: 5 months or 7 months post-enrollment
Paced Auditory Serial Addition Test Correct 2 seconds centile
time frame: 5 months or 7 months post-enrollment
Posttraumatic Growth Inventory (PTGI)
time frame: 0 months post-enrollment
Posttraumatic Growth Inventory (PTGI)
time frame: 3 months post-enrollment
Posttraumatic Growth Inventory (PTGI)
time frame: 15-18 months post-enrollment
Posttraumatic Growth Inventory (PTGI)
time frame: 5 months post-enrollment
Posttraumatic Growth Inventory (PTGI)
time frame: 5 months post-enrollment
Posttraumatic Growth Inventory (PTGI)
time frame: 7 months post-enrollment

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosed with chronic PTSD for six months or longer - Have a CAPS score showing moderate to severe PTSD symptoms - 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 - Are willing to refrain from taking any psychiatric medications during the study period - Willing to follow restrictions and guidelines concerning consumption of food, beverages or nicotine the night before and just prior to each MDMA 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 subject becoming suicidal - Agree to let the investigators know within 48 hours of any planned medical interventions; - Are proficient in reading and speaking English - Agree to have all psychotherapy sessions recorded to audio/video - Agree not to participant in any other interventional clinical trials during the course of the study 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, Dose Response Phase 2 Pilot Study of Manualized MDMA-Assisted Psychotherapy in Subjects With Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)
Principal investigator Marcela d'Otalora, MA, LPC
Description Posttraumatic stress disorder (PTSD) is a debilitating disorder that can develop after people experience a traumatic event, such as a rape, car accident or other life threatening event. PTSD is a worldwide health problem. PTSD is treated with psychotherapy or drugs, but these treatments do not help everyone. 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy might be a potential treatment for PTSD. MDMA is the active ingredient in ecstasy. Before it was made illegal, some psychotherapists combined MDMA with psychotherapy to help treat people with psychological problems, including PTSD. This study is a randomized, double-blind dose-response study comparing comparator-dose MDMA with full-dose MDMA. The study drug will be given as an initial dose possibly followed 1.5 hours later by a second dose half the size of the first dose. This Phase 2 pilot study will examine the safety and efficacy of MDMA-assisted psychotherapy in 23 subjects with chronic, treatment-resistant PTSD of at least 6 months duration who were unable to recover despite having received prior treatment with either drug or psychotherapy, or who discontinued treatment due to lack of tolerance for the treatment. Seven subjects will be randomized to full-dose MDMA and five subjects will be randomized to comparator-dose MDMA. MDMA will be administered in two experimental sessions lasting up to 8 hours and scheduled three to five weeks apart. The study will last up to one and a half years, including approximately three to five months of psychotherapy, and a long-term follow up visit scheduled a year after the final experimental session. Study subjects will have a medical and psychiatric examination to make sure that they can take part in the study. Once in the study, they will see the same male and female psychotherapist for the entire study. The subject will learn more about MDMA-assisted psychotherapy and the investigators will learn more about the subject during three preparatory sessions occurring before the first experimental session. During experimental sessions, subjects will receive an initial dose of either full or comparator-dose MDMA along with psychotherapy, and one and a half to two and a half hours later, the subject may have a supplemental dose half the size of the initial dose of MDMA. Vital signs and psychological distress will be measured throughout the experimental session. There will be three integrative psychotherapy sessions after each experimental session, including one occurring the day after an experimental session. Subjects will express, understand, bring together and connect any of their thoughts or feelings about your symptoms and their causes, and they will discuss their experience during experimental sessions with the therapists. Subjects will learn whether they received the comparator or the full dose of MDMA one month after their second experimental session. Subjects who received full-dose MDMA will finish Stage 1 and have a third experimental session, while subjects who received comparator-dose may go on to Stage 2, an open-label stage that is nearly identical to stage 1, with one instead of three preparatory sessions, and with experimental sessions with one of two active doses of MDMA. Symptoms of PTSD and depression, sleep quality, general psychological well-being, dissociation and posttraumatic growth (potentially positive effects of experiencing a traumatic event) will be measured in all subjects at baseline, one month after the second experimental session and 12 months after their final experimental session. Cognitive function will be assessed in all subjects at baseline and one month after the second experimental session. Participant reporting pain or tinnitus will record their symptoms throughout the study via visual analog scale. Subjects who received either Active Dose 1 or Active Dose 2 and go on to the third experimental session will complete questionnaires and measures of their symptoms of PTSD and depression, general psychological well-being, dissociation, sleep quality and posttraumatic growth two months after the third experimental session. Depending upon condition assignment or continuation to Stage 2, cognitive function will be assessed two months after the third Stage 1 or Stage 2 session. Subjects assigned to comparator-dose MDMA will be tested one month after their second Stage 2 experimental session and two months after the third experimental session. People will also complete measures of their experience of the experimental session soon after each experimental session. This study will compare the effects of MDMA-assisted psychotherapy with comparator versus full-dose MDMA, and it will also assess the duration of any changes in symptoms a year after MDMA-assisted psychotherapy.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Multidisciplinary Association for Psychedelic Studies.