Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-1)
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ClinicalTrials.gov Identifier: NCT01404754 |
Recruitment Status :
Completed
First Posted : July 28, 2011
Last Update Posted : October 13, 2022
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Condition or disease | Intervention/treatment | Phase |
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Psychological Effects of Study Drug | Drug: Lactose (inactive placebo) Drug: 3,4-methylenedioxymethamphetamine | Phase 1 |
3,4-methylenedioxymethamphetamine (MDMA) produces changes in feelings and thoughts. It appears to have a unique pharmacological profile distinct from psychostimulants and classical hallucinogenic (psychedelic) compounds. Its unique properties have led to interest in using it in combination with psychotherapy. So far, studies in healthy volunteers have examined the effects of MDMA in a laboratory setting rather than a psychotherapeutic setting.
This study is a Phase 1 study for up to a hundred people, The information gathered during this study may help us better understand the psychological effects produced by MDMA and how those effects can more effectively be used within a therapeutic context, as with people with PTSD. Participants will be healthy volunteers who have completed a program training them in conducting MDMA-assisted psychotherapy. In this randomized, double blind study, subjects will receive placebo and MDMA during two sessions scheduled at least two days apart in a psychotherapy setting. Mood, self-reported interpersonal closeness, psychological symptoms, blood pressure, heart rate and body temperature will be measured, and personality will be measured prior to the first therapy-like session and two months after the second session.
The study will follow a cross-over design, meaning that all participants will receive both MDMA and placebo, with order of session randomly assigned. Study participants will have a preparatory session prior to each experimental session and an integrative session after each session. The researchers will contact them via telephone one and two months after the second experimental session. By comparing changes in mood, feelings of emotional closeness to the self and others and psychological symptoms after placebo and after MDMA, the investigators hope to learn something about the effects of MDMA on mood, subjective experience and the way we think and feel about others.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 107 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | A Phase 1 Placebo-Controlled, Double-Blind Crossover Study to Assess Psychological Effects of MDMA When Administered to Healthy Volunteers |
Actual Study Start Date : | April 21, 2011 |
Actual Primary Completion Date : | August 5, 2022 |
Actual Study Completion Date : | September 13, 2022 |
Arm | Intervention/treatment |
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Placebo Comparator: Lactose (Inactive Placebo)
Participant receives inactive placebo during day-long experimental session. Mood, interpersonal closeness, psychological symptoms are measured before, during and after the session, and vital signs (blood pressure, heart rate, body temperature) are measured during the session.
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Drug: Lactose (inactive placebo)
Placebo in an equivalent weight to MDMA will be administered in identical appearing capsules during one of two experimental sessions. An equivalent to the initial and supplemental dose will exist. |
Active Comparator: 3,4-methylenedioxymethamphetamine
Participant receives 125 mg MDMA possibly followed by 62.5 mg MDMA during a day-long experimental session. Mood, interpersonal closeness, psychological symptoms are measured before, during and after the session, and vital signs (blood pressure, heart rate, body temperature) are measured during the session.
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Drug: 3,4-methylenedioxymethamphetamine
125 mg MDMA will be administered in opaque capsules at the outside of one of two experimental sessions, and upon mutual agreement between the investigator and participant, 62.5 mg may be administered 1.5 to 2.5 hours later. |
- Profile of Mood States (POMS) [ Time Frame: Experimental session approximately six hours after drug administration ]Assesses current mood state
- Profile of Mood States (POMS) [ Time Frame: Day prior to each experimental session ]Assesses current mood state
- Profile of Mood States (POMS) [ Time Frame: Day after each experimental session ]Assesses current mood state
- Interpersonal closeness measure [ Time Frame: Day prior to experimental session ]Visual analog scale assessing emotional closeness to self and four other targets
- Interpersonal closeness measure [ Time Frame: Day of experimental session approximately six hours post-drug administration ]Visual analog scale assessing emotional closeness to self and four other targets
- Interpersonal closeness measure [ Time Frame: Day after each experimental session ]Visual analog scale assessing emotional closeness to self and four other targets
- Brief Symptom Inventory (BSI) [ Time Frame: Day prior to each experimental session ]Self-report measure assessing psychiatric symptoms
- Brief Symptom Inventory (BSI) [ Time Frame: Day of experimental session prior to drug administration ]Self-report measure assessing psychiatric symptoms
- Brief Symptom Inventory (BSI) [ Time Frame: Day of experimental session approximately five to six hours after drug administration ]Self-report measure assessing psychiatric symptoms
- Brief Symptom Inventory (BSI) [ Time Frame: Day after each experimental session ]Self-report measure assessing psychiatric symptoms
- Columbia Suicide Severity Rating Scale (adapted C-SSRS) [ Time Frame: Day prior to each experimental session ]Clinician-administered measure of suicide risk
- Neuroticism Extroversion Openness Personality Inventory [ Time Frame: At baseline ]Self-report measure of five personality factors; Neuroticism, extroversion, openness to experience, conscientiousness and agreeableness
- Neuroticism Extroversion Openness Personality Inventory [ Time Frame: Two months after the second experimental session ]Self-report measure of five personality factors; Neuroticism, extroversion, openness to experience, conscientiousness and agreeableness
- Columbia Suicide Severity Rating Scale (adapted C-SSRS) [ Time Frame: Day after each experimental session ]Clinician-administered measure of suicide risk
- Columbia Suicide Severity Rating Scale (adapted C-SSRS) [ Time Frame: One month after the second experimental session ]Clinician-administered measure of suicide risk
- Columbia Suicide Severity Rating Scale (adapted C-SSRS) [ Time Frame: Two months after the second experimental session ]Clinician-administered measure of suicide risk
- Columbia Suicide Severity Rating Scale (adapted C-SSRS) [ Time Frame: Day six and 12 of telephone contact after second experimental session ]Clinician-administered measure of suicide risk
- Columbia Suicide Severity Rating Scale (adapted C-SSRS) [ Time Frame: Day of each experimental session prior to drug administration ]Clinician-administered measure of suicide risk
- Columbia Suicide Severity Rating Scale (adapted C-SSRS) [ Time Frame: Day of each experimental session approximately five to six hours after drug administration ]Clinician-administered measure of suicide risk
- Blood pressure (SBP/DBP) [ Time Frame: Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours ]Periodic assessment of participant blood pressure during both experimental sessions.
- Heart rate (pulse) [ Time Frame: Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours ]Periodic assessment of participant pulse during both experimental sessions.
- Body temperature [ Time Frame: Approximately every 60 minutes for each experimental session ]Periodic assessment of participant body temperature during both experimental sessions.

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- have successfully completed a sponsor-supported program for training therapists to perform MDMA-assisted psychotherapy research;
- are at least 21 years old;
- Are willing to follow all rules and restrictions related to study participation, including restrictions on medication use for a week prior to experimental sessions and restrictions on food and alcohol consumption on the day prior to each experimental session.
- are willing to remain overnight at the study site;
- agree to have transportation other than driving themselves after the integrative session on the day after each experimental session;
- are willing to be contacted via telephone for all necessary telephone contacts;
- if a woman of childbearing potential, must have a negative pregnancy test and agree to use an effective form of birth control;
- are proficient in speaking and reading English;
- agree to have all clinic visit sessions recorded to audio and video
Exclusion Criteria:
- are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control;
- weigh less than 48 kg;
- have used "ecstasy" (material represented as containing MDMA) within 6 months of the MDMA session;
- require ongoing therapy with a psychotropic drug;
- Are abusing illegal drugs
- 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.

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): NCT01404754
United States, Colorado | |
Aguazul Bluewater, Inc. | |
Boulder, Colorado, United States, 80304 | |
United States, New Mexico | |
Santa Fe MDMA Therapy Training, LLC | |
Santa Fe, New Mexico, United States, 87508 | |
United States, South Carolina | |
Zen Therapeutic Solutions | |
Mount Pleasant, South Carolina, United States, 29464 |
Study Director: | Michael M Mithoefer, MD | MAPS Public Benefit Corp. |
Responsible Party: | Multidisciplinary Association for Psychedelic Studies |
ClinicalTrials.gov Identifier: | NCT01404754 |
Other Study ID Numbers: |
MT-1 |
First Posted: | July 28, 2011 Key Record Dates |
Last Update Posted: | October 13, 2022 |
Last Verified: | January 2022 |
MDMA mood subjective effects interpersonal closeness |
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 |