Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-1)

Study Description

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Brief Summary:

This study will compare the effects of methylenedioxymethamphetamine (MDMA) and placebo on mood and psychological experience in people trained to practice MDMA-assistant psychotherapy in a therapy-like setting. Study participants will prepare for the experience with the investigators. After preparation, they will have two day-long sessions, one with placebo and one with MDMA, with the second session happening two days after the first. Order of session will be assigned randomly and the study will be double-blind. Subjects will complete measures and talk about the experience on the day after each session. Mood, psychological symptoms, and interpersonal closeness will be measured before and after each session. The investigators will speak with subjects again one and two months after the second experimental session, and subjects will complete a personality questionnaire two months after the second experimental session.

Condition or disease	Intervention/treatment	Phase
Psychological Effects of Study Drug	Drug: Lactose (inactive placebo); Drug: 3,4-methylenedioxymethamphetamine	Phase 1

Detailed Description:

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 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
Study Start Date :	October 2011
Estimated Primary Completion Date :	June 2018
Estimated Study Completion Date :	October 2018

Arms and Interventions

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Arm	Intervention/treatment
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.	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.	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.

Outcome Measures

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Primary Outcome Measures :

1. Profile of Mood States (POMS) [ Time Frame: Experimental session approximately six hours after drug administration ]
   Assesses current mood state
2. Profile of Mood States (POMS) [ Time Frame: Day prior to each experimental session ]
   Assesses current mood state
3. Profile of Mood States (POMS) [ Time Frame: Day after each experimental session ]
   Assesses current mood state

Secondary Outcome Measures :

1. Interpersonal closeness measure [ Time Frame: Day prior to experimental session ]
   Visual analog scale assessing emotional closeness to self and four other targets
2. 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
3. Interpersonal closeness measure [ Time Frame: Day after each experimental session ]
   Visual analog scale assessing emotional closeness to self and four other targets
4. Brief Symptom Inventory (BSI) [ Time Frame: Day prior to each experimental session ]
   Self-report measure assessing psychiatric symptoms
5. Brief Symptom Inventory (BSI) [ Time Frame: Day of experimental session prior to drug administration ]
   Self-report measure assessing psychiatric symptoms
6. Brief Symptom Inventory (BSI) [ Time Frame: Day of experimental session approximately five to six hours after drug administration ]
   Self-report measure assessing psychiatric symptoms
7. Brief Symptom Inventory (BSI) [ Time Frame: Day after each experimental session ]
   Self-report measure assessing psychiatric symptoms
8. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Day prior to each experimental session ]
   Clinician-administered measure of suicide risk
9. Neuroticism Extroversion Openness Personality Inventory [ Time Frame: At baseline ]
   Self-report measure of five personality factors; Neuroticism, extroversion, openness to experience, conscientiousness and agreeableness
10. 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
11. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Day after each experimental session ]
    Clinician-administered measure of suicide risk
12. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: One month after the second experimental session ]
    Clinician-administered measure of suicide risk
13. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Two months after the second experimental session ]
    Clinician-administered measure of suicide risk
14. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Day six and 12 of telephone contact after second experimental session ]
    Clinician-administered measure of suicide risk
15. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Day of each experimental session prior to drug administration ]
    Clinician-administered measure of suicide risk
16. Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Day of each experimental session approximately five to six hours after drug administration ]
    Clinician-administered measure of suicide risk
17. 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.
18. 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.
19. Body temperature [ Time Frame: Approximately every 60 minutes for each experimental session ]
    Periodic assessment of participant body temperature during both experimental sessions.

Eligibility Criteria

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Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Locations

United States, Colorado
Offices of Marcela d'Otalora
Boulder, Colorado, United States, 80304
United States, South Carolina
Offices of Michael Mithoefer
Mount Pleasant, South Carolina, United States, 29464

Sponsors and Collaborators

Multidisciplinary Association for Psychedelic Studies

Investigators

Principal Investigator:	Michael M Mithoefer, MD	Private practice

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier:	NCT01404754 History of Changes
Other Study ID Numbers:	MT-1
First Posted:	July 28, 2011
Last Update Posted:	November 6, 2017
Last Verified:	October 2017

Keywords provided by Multidisciplinary Association for Psychedelic Studies:

MDMA; mood; subjective effects; interpersonal closeness

Additional relevant MeSH terms:

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