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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier:
NCT01404754
First received: July 19, 2011
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Psychological Effects of Study Drug
Drug: Lactose (inactive placebo)
Drug: 3,4-methylenedioxymethamphetamine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Profile of Mood States (POMS) [ Time Frame: Experimental session approximately six hours after drug administration ] [ Designated as safety issue: No ]
    Assesses current mood state

  • Profile of Mood States (POMS) [ Time Frame: Day prior to each experimental session ] [ Designated as safety issue: No ]
    Assesses current mood state

  • Profile of Mood States (POMS) [ Time Frame: Day after each experimental session ] [ Designated as safety issue: No ]
    Assesses current mood state


Secondary Outcome Measures:
  • Interpersonal closeness measure [ Time Frame: Day prior to experimental session ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Visual analog scale assessing emotional closeness to self and four other targets

  • Interpersonal closeness measure [ Time Frame: Day after each experimental session ] [ Designated as safety issue: No ]
    Visual analog scale assessing emotional closeness to self and four other targets

  • Brief Symptom Inventory (BSI) [ Time Frame: Day prior to each experimental session ] [ Designated as safety issue: Yes ]
    Self-report measure assessing psychiatric symptoms

  • Brief Symptom Inventory (BSI) [ Time Frame: Day of experimental session prior to drug administraiton ] [ Designated as safety issue: Yes ]
    Self-report measure assessing psychiatric symptoms

  • Brief Symptom Inventory (BSI) [ Time Frame: Day of experimental session approximately five to six hours after drug administraiton ] [ Designated as safety issue: Yes ]
    Self-report measure assessing psychiatric symptoms

  • Brief Symptom Inventory (BSI) [ Time Frame: Day after each experimental session ] [ Designated as safety issue: Yes ]
    Self-report measure assessing psychiatric symptoms

  • Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Day prior to each experimental session ] [ Designated as safety issue: Yes ]
    Clinician-administered measure of suicide risk

  • Neuroticism Extroversion Openness Personality Inventory [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Self-report measure of five personality factors; Neuroticism, extroversion, openness to experience, conscientiousness and agreeableness

  • Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Day after each experimental session ] [ Designated as safety issue: Yes ]
    Clinician-administered measure of suicide risk

  • Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: One month after the second experimental session ] [ Designated as safety issue: Yes ]
    Clinician-administered measure of suicide risk

  • Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Two months after the second experimental session ] [ Designated as safety issue: Yes ]
    Clinician-administered measure of suicide risk

  • Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Day six and 12 of telephone contact after second experimental session ] [ Designated as safety issue: Yes ]
    Clinician-administered measure of suicide risk

  • Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Day of each experimental session prior to drug administration ] [ Designated as safety issue: Yes ]
    Clinician-administered measure of suicide risk

  • Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Day of each experimental session approximately five to six hours after drug administration ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Periodic assessment of participant pulse during both experimental sessions.

  • Body temperature [ Time Frame: Approximately every 60 minutes for each experimental session ] [ Designated as safety issue: Yes ]
    Periodic assessment of participant body temperature during both experimental sessions.


Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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: MDMA
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.

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 twenty 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 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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;
  • history of or current primary psychotic disorder, bipolar affective disorder type 1 or, dissociative identity disorder
  • current psychiatric diagnosis other than adjustment 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 standard criteria;
  • have a history of hyponatremia or hyperthermia;
  • 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;
  • Substance abuse or dependence for any substance save caffeine or nicotine in the past 60 days;
  • 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: NCT01404754

Locations
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

No publications provided

Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT01404754     History of Changes
Other Study ID Numbers: MT-1
Study First Received: July 19, 2011
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration

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
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 August 01, 2014