Study Comparing Three Doses of MDMA Along With Psychotherapy in Veterans With Posttraumatic Stress Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Multidisciplinary Association for Psychedelic Studies
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier:
NCT01211405
First received: August 6, 2010
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Posttraumatic Stress Disorder
Drug: Low dose 3,4-methylenedioxymethamphetamine
Drug: 3,4-methylenedioxymethamphetamine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Multidisciplinary Association for Psychedelic Studies:

Primary Outcome Measures:
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Clinician-administered and scored assessment of posttraumatic stress disorder (PTSD) following diagnostic criteria found in DSM IV.It produces a global score, a dichotomous diagnostic scale, and subscales

  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: One mo after Experimental Session 2 ] [ Designated as safety issue: No ]
    Clinician-administered and scored assessment of posttraumatic stress disorder (PTSD) following diagnostic criteria found in DSM IV.It produces a global score, a dichotomous diagnostic scale, and subscales

  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Two months after Experimental Session 3 ] [ Designated as safety issue: No ]
    Clinician-administered and scored assessment of posttraumatic stress disorder (PTSD) following diagnostic criteria found in DSM IV.It produces a global score, a dichotomous diagnostic scale, and subscales

  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 12 month follow up ] [ Designated as safety issue: No ]
    Clinician-administered and scored assessment of posttraumatic stress disorder (PTSD) following diagnostic criteria found in DSM IV.It produces a global score, a dichotomous diagnostic scale, and subscales


Secondary Outcome Measures:
  • Global Assessment of Function (GAF) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A single-item clinician-assessed measure of psychological function and well-being

  • BDI-II [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Self-report measure of depression symptoms

  • Posttraumatic Growth Inventory [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    A self-report measure assessing potential benefits or reframing of traumatic event or events

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Every face to face visit, two of 7 phone contact days, 12 month follow up ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Body temperature [ Time Frame: Every 60-90 minutes throughout first 8-h experimental sessionm ] [ Designated as safety issue: Yes ]
    Body temperature assessed via tympanic thermometer

  • Global Assessment of Function (GAF) [ Time Frame: One month after Experimetnal Session 2 ] [ Designated as safety issue: No ]
    A single-item clinician-assessed measure of psychological function and well-being

  • Global Assessment of Function (GAF) [ Time Frame: Two months after Experimental Session 3 ] [ Designated as safety issue: No ]
    A single-item clinician-assessed measure of psychological function and well-being

  • Global Assessment of Function (GAF) [ Time Frame: 12 month follow up ] [ Designated as safety issue: No ]
    A single-item clinician-assessed measure of psychological function and well-being

  • BDI-II [ Time Frame: One month after Experimental Session 2 ] [ Designated as safety issue: No ]
    Self-report measure of depression symptoms

  • BDI-II [ Time Frame: Two months after Experimental Session 3 ] [ Designated as safety issue: No ]
    Self-report measure of depression symptoms

  • BDI-II [ Time Frame: 12 month follow up ] [ Designated as safety issue: No ]
    Self-report measure of depression symptoms

  • Posttraumatic Growth Inventory [ Time Frame: One month after Experimental Session 2 ] [ Designated as safety issue: No ]
    A self-report measure assessing potential benefits or reframing of traumatic event or events

  • Posttraumatic Growth Inventory [ Time Frame: Two months after Experimental Session 3 ] [ Designated as safety issue: No ]
    A self-report measure assessing potential benefits or reframing of traumatic event or events

  • Posttraumatic Growth Inventory [ Time Frame: 12 month follow up ] [ Designated as safety issue: No ]
    A self-report measure assessing potential benefits or reframing of traumatic event or events

  • Peak Body temperature [ Time Frame: Peak value from measurements made every 60-90 minutes throughout second 8-h experimental sessionm ] [ Designated as safety issue: Yes ]
    Body temperature assessed via tympanic thermometer

  • Peak Body temperature [ Time Frame: Peak value from measurements made every 60-90 minutes throughout third 8-h experimental sessionm ] [ Designated as safety issue: Yes ]
    Body temperature assessed via tympanic thermometer

  • Peak blood pressure (systolic) [ Time Frame: Peak value from measuremades made every 15-30 min throughout first eight-hour experimental session ] [ Designated as safety issue: Yes ]
    Measuring systolic blood pressure

  • Peak blood pressure (systolic) [ Time Frame: Peak value from measurements made every 15-30 min throughout second eight-hour experimental session ] [ Designated as safety issue: Yes ]
    Measuring systolic blood pressure

  • Peak blood pressure (systolic) [ Time Frame: Peak value from measurements made every 15-30 min throughout third eight-hour experimental session ] [ Designated as safety issue: Yes ]
    Measuring systolic blood pressure

  • Peak Pulse [ Time Frame: Peak value from measurements made every 15-30 min throughout first eight-hour experimental session ] [ Designated as safety issue: Yes ]
    Assessing heart rate via pulse

  • Peak Pulse [ Time Frame: Peak value from measurement made every 15-30 min throughout second eight-hour experimental session ] [ Designated as safety issue: Yes ]
    Assessing heart rate via pulse

  • Peak Pulse [ Time Frame: Peak value from measurements made every 15-30 min throughout third eight-hour experimental session ] [ Designated as safety issue: Yes ]
    Assessing heart rate via pulse

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Session prior to first experimental session ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Twice during first experimental session ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Twice during second experimental session ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Twice during third experimental session ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 12 month follow up ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: First psychotherapy session after experimental session 1 ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Second psychotherapy session after experimental session 1 ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Third psychotherapy session after experimental session 1 ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: First psychotherapy session after experimental session 2 ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Second psychotherapy session after experimental session 2 ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Third psychotherapy session after experimental session 2 ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: First psychotherapy session after experimental session 3 ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Second psychotherapy session after experimental session 3 ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Third psychotherapy session after experimental session 3 ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Phone contact days 2 and 7 after experimental session 1 ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Phone contact days 2 and 7 after experimental session 2 ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Phone contact days 2 and 7 after experimental session 3 ] [ Designated as safety issue: Yes ]
    A clinician-administered and scored measure of suicidal ideation and behavior, consisting of series of questions and adaptive to responses to questions.

  • Peak Subjective Units of Distress [ Time Frame: Peak value from measurements made every sixty-ninety minutes during experimental session 1 ] [ Designated as safety issue: Yes ]
    Single item assesses self-reported psychological distress

  • Peak Subjective Units of Distress [ Time Frame: Peak value from measurements made every sixty-ninety minutes during experimental session 2 ] [ Designated as safety issue: Yes ]
    Single item assesses self-reported psychological distress

  • Peak Subjective Units of Distress [ Time Frame: Peak value from measurements made every sixty-ninety minutes during experimental session 3 ] [ Designated as safety issue: Yes ]
    Single item assesses self-reported psychological distress

  • Pittsburgh Sleep Quality Index [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Self-report measure of sleep quality

  • Pittsburgh Sleep Quality Index [ Time Frame: One month after Experimental Session 2 ] [ Designated as safety issue: No ]
    Self-report measure of sleep quality

  • Pittsburgh Sleep Quality Index [ Time Frame: Two months after Experimental Session 3 ] [ Designated as safety issue: No ]
    Self-report measure of sleep quality

  • States of Consciousness Questionnaire [ Time Frame: After experimental session 1 ] [ Designated as safety issue: No ]
    Assesses subjective effects and experience of alterations in consciousness

  • States of Consciousness Questionnaire [ Time Frame: After experimental session 2 ] [ Designated as safety issue: No ]
    Assesses subjective effects and experience of alterations in consciousness

  • States of Consciousness Questionnaire [ Time Frame: After experimental session 3 ] [ Designated as safety issue: No ]
    Assesses subjective effects and experience of alterations in consciousness

  • Neuroticism Extroversion Openness Inventory (NEO) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Self-report, Assesses five personality factors

  • Neuroticism Extroversion Openness Inventory (NEO) [ Time Frame: 1 months after Experimental Session 2 ] [ Designated as safety issue: No ]
    Self-report, Assesses five personality factors

  • Neuroticism Extroversion Openness Inventory (NEO) [ Time Frame: 12 months after Experimental Session 3 ] [ Designated as safety issue: No ]
    Self-report, Assesses five personality factors

  • Pre-drug body temperature [ Time Frame: Body temperature prior to drug administration during first experimental session ] [ Designated as safety issue: Yes ]
    Body temperature assessed via tympanic thermometer

  • Peak body temperature [ Time Frame: Peak value from measurements made every 60-90 nin during first experimental session ] [ Designated as safety issue: Yes ]
    Body temperature assessed via tympanic thermometer

  • Pre-drug body temperature [ Time Frame: Body temperature prior to drug administration during second experimental session ] [ Designated as safety issue: Yes ]
    Body temperature assessed via tympanic thermometer

  • Pre-drug body temperature [ Time Frame: Body temperature prior to drug administration during third experimental session ] [ Designated as safety issue: Yes ]
    Body temperature assessed via tympanic thermometer

  • Endpoint body temperature [ Time Frame: Body temperature 7 h +/-30 min post drug administration during first experimental session ] [ Designated as safety issue: Yes ]
    Body temperature assessed via tympanic thermometer

  • Endpoint body temperature [ Time Frame: Body temperature 7 h +/- 30 min post drug administration during second experimental session ] [ Designated as safety issue: Yes ]
    Body temperature assessed via tympanic thermometer

  • Endpoint body temperature [ Time Frame: Body temperature 7 h +/- 30 min post drug administration during third experimental session ] [ Designated as safety issue: Yes ]
    Body temperature assessed via tympanic thermometer

  • Pre-drug Pulse [ Time Frame: Pre-drug value at first eight-hour experimental session ] [ Designated as safety issue: Yes ]
    Assessing heart rate via pulse

  • Endpoint Pulse [ Time Frame: Pulse 7 h +/- 30 min post drug on first 8-hour experimental session ] [ Designated as safety issue: Yes ]
    Assessing heart rate via pulse

  • Pre-drug Pulse [ Time Frame: Pre-drug pulse on second eight-hour experimental session ] [ Designated as safety issue: Yes ]
    Assessing heart rate via pulse

  • Endpoint Pulse [ Time Frame: Pulse 7 h +/- 30 min post-drug on second eight-hour experimental session ] [ Designated as safety issue: Yes ]
    Assessing heart rate via pulse

  • Pre-drug Pulse [ Time Frame: Pre-drug pulse on the third eight-hour experimental session ] [ Designated as safety issue: Yes ]
    Assessing heart rate via pulse

  • Endpoint Pulse [ Time Frame: Pulse 7 h +/- 30 min post-drug on third eight-hour experimental session ] [ Designated as safety issue: Yes ]
    Assessing heart rate via pulse

  • Peak blood pressure (diastolic) [ Time Frame: Peak value from measuremades made every 15-30 min throughout first eight-hour experimental session ] [ Designated as safety issue: Yes ]
    Measuring diastolic blood pressure

  • Peak lood pressure (diastolic) [ Time Frame: Peak value from measurements made every 15-30 min throughout second eight-hour experimental session ] [ Designated as safety issue: Yes ]
    Measuring diastolic blood pressure

  • Peak blood pressure (diastolic) [ Time Frame: Peak value from measurements made every 15-30 min throughout third eight-hour experimental session ] [ Designated as safety issue: Yes ]
    Measuring diastolic blood pressure

  • Pre-drug blood pressure [ Time Frame: Prior to drug administration on first experimental session ] [ Designated as safety issue: Yes ]
    Measurement of blood pressure as systolic/diastolic

  • Endpoint blood pressure [ Time Frame: Value at 7 h +/- 30 min post-drug on first 8-hour experimental session ] [ Designated as safety issue: Yes ]
    Measurement of blood pressure as systolic/diastolic

  • Pre-drug blood pressure [ Time Frame: Value prior to drug administration on second experimental session ] [ Designated as safety issue: Yes ]
    Measurement as systolic/diastolic

  • Endpoint blood pressure [ Time Frame: Value 7 h +/- 30 min post-drug on second 8-hour ecxperimental session ] [ Designated as safety issue: Yes ]
    Measurement of blood pressure as systolic/diastolic

  • Pre-drug blood pressure [ Time Frame: Value prior to drug administration on third experimental session ] [ Designated as safety issue: Yes ]
    Measurement of blood pressure as systolic/diastolic

  • Endpoint blood pressure [ Time Frame: Value 7 h +/- 30 min post-drug on third 8-hour experimental session ] [ Designated as safety issue: Yes ]
    Measurement of blood pressure as systolic/diastolic


Estimated Enrollment: 24
Study Start Date: September 2010
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low dose MDMA
Participants will receive 30 mg MDMA during each of two blinded experimental sessions.
Drug: Low dose 3,4-methylenedioxymethamphetamine
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
Other Names:
  • MDMA; (
  • +/-)-3,4-methylenedioxymethamphetamine;
  • methylenedioxymethamphetamine
Active Comparator: Medium dose MDMA
Participants will receive 75 mg MDMA on each of two blinded experimental sessions
Drug: 3,4-methylenedioxymethamphetamine
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
Other Names:
  • MDMA;
  • (+/-)-3,4-methylenedioxymethamphetamine
  • methylenedioxymethamphetamine
Experimental: Full dose MDMA
Participants will receive 125 mg MDMA during each of two blinded experimental sessions, followed by a third open label session.
Drug: 3,4-methylenedioxymethamphetamine
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.
Other Names:
  • MDMA;
  • (+/-)-3,4-methylenedioxymethamphetamine
  • methylenedioxymethamphetamine

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with chronic PTSD, duration of 6 months or longer resulting from traumatic experience during military service;
  • have a CAPS score of 50 or higher, indicating moderate to severe PTSD symptoms;
  • at least one unsuccessful attempt at treatment for PTSD either with psychotherapy (talk therapy) or with drugs such as SSRIs or SNRIs, or discontinuing treatment because of inability to tolerate psychotherapy or drug therapy.
  • are at least 18 years old;
  • If in ongoing psychotherapy at the time they are recruited into the study, must sign a release for the investigators to communicate directly with their therapist, and may not change therapists, increase the frequency of therapy or commence any new type of therapy until after the evaluation session 2 months after the final experimental session. Subjects who do not live within reasonable driving distance of the study site must have a therapist in the area in which they live;
  • are willing to refrain from taking any psychiatric medications during the study period, with the exception of gabapentin when prescribed for pain control or stimulants for ADHD if discontinued five half-lives before and 10 days after each experimental session.
  • agree that, for one week preceding 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 MDMA session
  • are 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:

  • are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control;
  • have past or current psychotic disorder, bipolar affective disorder type 1 or, dissociative identity disorder;
  • have evidence or history of coronary artery disease or cerebral or peripheral vascular disease, hepatic disease with abnormal liver enzymes, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA administration;
  • have hypertension using the standard criteria unless it is successfully treated and well controlled with medication. In this case subjects with well-controlled hypertension may be enrolled if they pass additional screening to rule out underlying cardiovascular disease (see methods).
  • have liver disease with the exception of asymptomatic subjects with Hepatitis C who have undergone additional evaluation
  • have history of hyponatremia or hyperthermia;
  • weigh less than 48 kg;
  • would present a serious suicide risk, or who, in the judgment of the investigator, are likely to require hospitalization during the course of the study;
  • Would present a serious risk to others
  • have used "ecstasy" (material represented as containing MDMA) more than five times within the last 10 years or at least once within 6 months of the MDMA session;
  • require ongoing concomitant therapy with a psychotropic drug;
  • meet Diagnostic and Statistical Manual of Mental Disorders criteria for substance abuse or dependence for any substance save caffeine or nicotine in the past 60 days;
  • are unable to give adequate informed consent;
  • have any current problem or a history of substance abuse which, in the opinion of the investigator or medical monitor, might interfere with participation in the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01211405

Contacts
Contact: Ann Mithoefer, BSN 843-849-6899

Locations
United States, South Carolina
Offices of Michael Mithoefer Recruiting
Mount Pleasant, South Carolina, United States, 29464-4345
Sponsors and Collaborators
Multidisciplinary Association for Psychedelic Studies
Investigators
Principal Investigator: Michael C Mithoefer, MD Private practice
  More Information

No publications provided

Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT01211405     History of Changes
Other Study ID Numbers: MP-8
Study First Received: August 6, 2010
Last Updated: March 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Multidisciplinary Association for Psychedelic Studies:
MDMA
Psychotherapy
Veterans
Posttraumatic Stress Disorder

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
N-Methyl-3,4-methylenedioxyamphetamine
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014