A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD
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| ClinicalTrials.gov Identifier: NCT03537014 |
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Recruitment Status :
Recruiting
First Posted : May 25, 2018
Last Update Posted : January 16, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Posttraumatic Stress Disorder | Behavioral: Psychotherapy Drug: MDMA Drug: Placebo | Phase 3 |
PTSD is a serious debilitating disorder that negatively impacts a person's daily life. PTSD is a stress-related psychiatric condition that may occur following a traumatic event such as war, disaster, sexual abuse, violence, terrorism, and accidents. PTSD negatively impacts a person's daily life, resulting in relationship difficulties, difficulty in finding and maintaining a job, reduced cognitive and psychosocial functioning, substance abuse, high-cost healthcare use, and increased depression and suicide risk. Available PTSD treatments, including medications and therapy, effectively treat only a fraction of people who try them for adequate dose and duration. People with PTSD can be treated with psychotherapies and pharmacotherapies. In the past decade, there has been a growing amount of research into medications and other methods that may augment the effectiveness of psychotherapy for PTSD
3,4-methylenedioxymethamphetamine (MDMA) is a drug that releases serotonin, norepinephrine and dopamine in the brain and indirectly increases levels of the neurohormones oxytocin, arginine vasopressin and cortisol. The combined neurobiological effects of MDMA increase compassion, reduce defenses and fear of emotional injury, and enhance communication and introspection. MDMA produces anxiolytic and prosocial effects, which counteract avoidance and hyperarousal in the context of therapy. A combined treatment of MDMA and psychotherapy may be especially useful for treating PTSD.
This multi-site, double-blind, randomized Phase 3 study assesses the efficacy and safety of MDMA-assisted psychotherapy versus psychotherapy with placebo control in participants diagnosed with at least severe posttraumatic stress disorder (PTSD). The study will be conducted in N ≈ 100 participants. Participants will be enrolled in one of two groups at a 1:1 ratio. A flexible dose of MDMA or placebo, followed by a supplemental half-dose unless contraindicated, is administered during the Treatment Period with manualized psychotherapy in three monthly Experimental Sessions. This ~12-week Treatment Period is preceded by three Preparatory Sessions. During the Treatment Period, each Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy. The Primary Outcome measure is change in Clinician Administered PTSD Scale for DSM 5 (CAPS-5) from Baseline. Exploratory measures will address specific symptoms, or behavior that is sometimes related to PTSD. Drug safety will be assessed by measuring blood pressure, heart rate and body temperature during experimental sessions, collecting adverse events and measuring suicidal thoughts or behaviors with the Columbia Suicide Severity Rating Scale (CSSRS). This study will compare the effects of three manualized Experimental Sessions of psychotherapy supported by assisted by flexible doses of MDMA versus placebo. Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with mannitol and magnesium stearate or placebo alone (mannitol and magnesium stearate), followed 1.5 to 2 hours later by a supplemental half-dose (40 or 60 mg). Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized, double-blind between group comparison of change in PTSD symptoms |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Masking Description: | Use of separate databases for outcome measures and safety data. Assessment made by pool of independent raters. Randomization will be managed via an Interactive Web Randomization System (IWRS) based on a centralized randomization schedule developed by an independent third-party vendor to maintain blinding. |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder |
| Actual Study Start Date : | November 5, 2018 |
| Estimated Primary Completion Date : | November 5, 2019 |
| Estimated Study Completion Date : | December 18, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: MDMA
Administration of 80 or 120 mg MDMA in combination with psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg MDMA respectively.
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Behavioral: Psychotherapy
Standardized non-directive psychotherapy performed by therapist team
Other Name: Manualized MDMA-assisted psychotherapy Drug: MDMA Administration of 80 to 120 mg MDMA during three sessions of MDMA-assisted psychotherapy followed by a supplemental dose of 40 or 60 mg MDMA offered 1.5/2 hrs after the initial dose, respectively.
Other Name: 3,4-methylenedioxymethamphetamine |
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Placebo Comparator: Placebo
Administration of inactive placebo in combination with psychotherapy
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Behavioral: Psychotherapy
Standardized non-directive psychotherapy performed by therapist team
Other Name: Manualized MDMA-assisted psychotherapy Drug: Placebo Administration of placebo during three sessions of MDMA-assisted psychotherapy
Other Name: Inactive placebo |
- Change from Baseline in Clinician-Administered PTSD for DSM 5 [ Time Frame: 18 weeks post baseline post enrollment confirmation ]Global severity Scores on the CAPS-5, a measure of PTSD symptoms
- Change from Baseline in Beck Depression Inventory II (BDI-II) [ Time Frame: 18 weeks post enrollment confirmation ]Assesses self-reported depression symptoms
- Systolic Blood pressure (SBP) [ Time Frame: 4 weeks after enrollment ]Systolic blood pressure assessed 1.5 to 2 hours after initial MDMA/placebo dose during first of three experimental sessions
- Systolic Blood pressure (SBP) [ Time Frame: 8 weeks after enrollment ]Systolic blood pressure assessed 1.5 to 2 hours after initial MDMA/placebo dose during second of three experimental sessions
- Systolic Blood pressure (SBP) [ Time Frame: 12 weeks after enrollment ]Systolic blood pressure assessed 1.5 to 2 hours after initial MDMA/placebo dose during third of three experimental sessions
- Diastolic blood pressure (DBP) [ Time Frame: 4 weeks after enrollment ]Diastolic blood pressure assessed 1.5 to 2 hours after initial MDMA dose during first of three experimental sessions
- Diastolic blood pressure (DBP) [ Time Frame: 8 weeks after enrollment ]Diastolic blood pressure assessed 1.5 to 2 hours after initial MDMA/placebo dose during second of three experimental sessions
- Diastolic blood pressure (DBP) [ Time Frame: 12 weeks after enrollment ]Diastolic blood pressure assessed 1.5 to 2 hours after initial MDMA/placebo dose during third of three experimental sessions
- Pulse [ Time Frame: 4 weeks after enrollment ]Pulse assessed 1.5 to 2 hours after initial dose of MDMA or placebo during first of three experimental sessions
- Pulse [ Time Frame: 8 weeks after enrollment ]Pulse assessed 1.5 to 2 hours after initial dose of MDMA or placebo during second of three experimental sessions
- Pulse [ Time Frame: 12 weeks after enrollment ]Pulse assessed 1.5 to 2 hours after initial dose of MDMA or placebo during third of three experimental sessions
- Body temperature (BT) [ Time Frame: 4 weeks after enrollment ]BT assessed 1.5 to 2 hours after initial dose of MDMA or placebo during first of three experimental sessions.
- Body temperature (BT) [ Time Frame: 8 weeks after enrollment ]BT assessed 1.5 to 2 hours after initial dose of MDMA or placebo during second of three experimental sessions.
- Body temperature (BT) [ Time Frame: 12 weeks after enrollment ]BT assessed 1.5 to 2 hours after initial dose of MDMA or placebo during third of three experimental sessions.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Are at least 18 years old
- Are fluent in speaking and reading the predominantly used or recognized language of the study site
- Are able to swallow pills
- Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions
- Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
- Must agree to inform the investigators within 48 hours of any medical conditions and procedures
- If of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.
- Must not participate in any other interventional clinical trials during the duration of the study
- Must be willing to remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures
- At baseline, meet DSM-5 criteria for current severe PTSD
Exclusion Criteria:
- Are not able to give adequate informed consent
- Have uncontrolled hypertension
- Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] corrected by Bazett's formula)
- Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Have evidence or history of significant medical disorders
- Have symptomatic liver disease
- Have history of hyponatremia or hyperthermia
- Weigh less than 48 kilograms (kg)
- Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control
- Are abusing illegal drugs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537014
| United States, California | |
| New School Research LLT | Recruiting |
| North Hollywood, California, United States, 91601 | |
| Contact: Study coordinator 818-643-5234 info@newschoolresearch.com | |
| San Francisco Insight and Integration Center | Recruiting |
| San Francisco, California, United States, 94114 | |
| Contact: Study coordinator 415-400-5722 info@sfinsightcenter.com | |
| University of California San Francisco | Recruiting |
| San Francisco, California, United States, 94122 | |
| Contact: Study coordinator 510-985-3522 mdma.research@ucsf.edu | |
| United States, Colorado | |
| Aguazul-Blue Water Inc. | Recruiting |
| Boulder, Colorado, United States, 80302 | |
| Contact: Study coordinator 720-892-8395 info.boulderstudy@comcast.net | |
| Wholeness Center | Recruiting |
| Fort Collins, Colorado, United States, 80525 | |
| Contact: Study coordinator 970-825-6610 wcresearch@wholeness.com | |
| United States, Louisiana | |
| Ray Worthy Psychiatry LLC | Recruiting |
| New Orleans, Louisiana, United States, 70123 | |
| Contact: Study coordinator 504-689-6277 info.nolaresearch@gmail.com | |
| United States, Massachusetts | |
| Trauma Research Foundation | Recruiting |
| Boston, Massachusetts, United States, 02446 | |
| Contact: Study coordinator 617-651-2646 mdma.study.boston@gmail.com | |
| United States, New York | |
| New York University | Not yet recruiting |
| New York, New York, United States, 10016 | |
| Contact: Study coordinator | |
| Affective Care | Recruiting |
| New York, New York, United States, 10024 | |
| Contact: Study coordinator 917-830-4948 info@mdma.nyc | |
| Principal Investigator: Ingmar Gorman, PhD | |
| Principal Investigator: Casey Paleos, MD | |
| United States, South Carolina | |
| Zen Therapeutic Solutions, LLC | Recruiting |
| Mount Pleasant, South Carolina, United States, 29464 | |
| Contact: Study coordinator 843-882-5203 information.zts@gmail.com | |
| United States, Wisconsin | |
| University of Wisconsin at Madison | Not yet recruiting |
| Madison, Wisconsin, United States, 53705 | |
| Contact: Study coordinator | |
| Canada, British Columbia | |
| Providence Health Center | Not yet recruiting |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Contact: Study coordinator | |
| Israel | |
| Assaf Harofeh Research Fund | Not yet recruiting |
| Be'er Ya'aqov, Israel | |
| Contact: Study coordinator | |
| Sheba Fund for Health Services and Research | Not yet recruiting |
| Tel HaShomer, Israel | |
| Contact: Research coordinator | |
| Study Director: | Michael Mithoefer, MD | MAPS Public Benefit Corp. |
| Responsible Party: | Multidisciplinary Association for Psychedelic Studies |
| ClinicalTrials.gov Identifier: | NCT03537014 History of Changes |
| Other Study ID Numbers: |
MAPP1 |
| First Posted: | May 25, 2018 Key Record Dates |
| Last Update Posted: | January 16, 2019 |
| Last Verified: | January 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | We will share outcome data appearing in any published reports upon request. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
| Time Frame: | Data and study-related documents will be available when the database has been locked and data has been unblinded. |
| Access Criteria: | Interested persons should correspond with the central contact for the multisite study. |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
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Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders N-Methyl-3,4-methylenedioxyamphetamine Hallucinogens Physiological Effects of Drugs Psychotropic Drugs |
Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Adrenergic Agents |