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

A Phase 1 Placebo-Controlled, Double-Blind Crossover Study to Assess Psychological Effects of MDMA When Administered to Healthy Volunteers

The goal of this clinical trial is to study MDMA-assisted therapy in healthy volunteers. The main question it aims to answer is:

Do two sessions of MDMA-assisted therapy result in changes in mood, emotional closeness to self and others, and other psychological symptoms?

Researchers will compare MDMA-assisted therapy to placebo with therapy.

Participants will have a non-drug preparatory session prior to each experimental session and an integrative session after each experimental session. Participants who received MDMA will crossover to receive placebo and placebo participants will crossover to receive MDMA.

Study Overview

• Status: Completed
• Conditions: Psychological Effects of Study Drug
• Intervention / Treatment: Drug: Lactose (inactive placebo); Drug: midomafetamine HCl

Detailed Description

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
• Enrollment (Actual): 107
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Aguazul Bluewater, Inc.
  • New Mexico
    • Santa Fe, New Mexico, United States, 87508
      • Santa Fe MDMA Therapy Training, LLC
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Zen Therapeutic Solutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Engaged in 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
• Meet DSM-V criteria for substance abuse or dependence for any substance
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Lactose (Inactive Placebo); Participant receives inactive placebo during day-long experimental session.	Drug: Lactose (inactive placebo); Placebo in an equivalent weight to midomafetamine HCl will be administered in identical appearing capsules during one of two experimental sessions. An equivalent to the initial and supplemental dose will exist.; Other Names: placebo
Active Comparator: 3,4-methylenedioxymethamphetamine; Participant receives 120 mg midomafetamine HCl possibly followed by 40 mg midomafetamine HCl during a day-long experimental session.	Drug: midomafetamine HCl; 120 mg midomafetamine HCl will be administered in opaque capsules at the outside of one of two experimental sessions, and upon mutual agreement between the investigator and participant, 40 mg may be administered 1.5 to 2.5 hours later.; Other Names: MDMA; 3,4-methylenedioxymethamphetamine; midomafetamine; MDMA HCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Profile of Mood States (POMS)	Assesses current mood state	Experimental session approximately six hours after drug administration
Profile of Mood States (POMS)	Assesses current mood state	Day prior to each experimental session
Profile of Mood States (POMS)	Assesses current mood state	Day after each experimental session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interpersonal closeness measure	Visual analog scale assessing emotional closeness to self and four other targets	Day prior to experimental session
Interpersonal closeness measure	Visual analog scale assessing emotional closeness to self and four other targets	Day of experimental session approximately six hours post-drug administration
Interpersonal closeness measure	Visual analog scale assessing emotional closeness to self and four other targets	Day after each experimental session
Brief Symptom Inventory (BSI)	Self-report measure assessing psychiatric symptoms	Day prior to each experimental session
Brief Symptom Inventory (BSI)	Self-report measure assessing psychiatric symptoms	Day of experimental session prior to drug administration
Brief Symptom Inventory (BSI)	Self-report measure assessing psychiatric symptoms	Day of experimental session approximately five to six hours after drug administration
Brief Symptom Inventory (BSI)	Self-report measure assessing psychiatric symptoms	Day after each experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)	Clinician-administered measure of suicide risk	Day prior to each experimental session
Neuroticism Extroversion Openness Personality Inventory	Self-report measure of five personality factors; Neuroticism, extroversion, openness to experience, conscientiousness and agreeableness	At baseline
Neuroticism Extroversion Openness Personality Inventory	Self-report measure of five personality factors; Neuroticism, extroversion, openness to experience, conscientiousness and agreeableness	Two months after the second experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)	Clinician-administered measure of suicide risk	Day after each experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)	Clinician-administered measure of suicide risk	One month after the second experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)	Clinician-administered measure of suicide risk	Two months after the second experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)	Clinician-administered measure of suicide risk	Day six and 12 of telephone contact after second experimental session
Columbia Suicide Severity Rating Scale (adapted C-SSRS)	Clinician-administered measure of suicide risk	Day of each experimental session prior to drug administration
Columbia Suicide Severity Rating Scale (adapted C-SSRS)	Clinician-administered measure of suicide risk	Day of each experimental session approximately five to six hours after drug administration
Blood pressure (SBP/DBP)	Periodic assessment of participant blood pressure during both experimental sessions.	Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours
Heart rate (pulse)	Periodic assessment of participant pulse during both experimental sessions.	Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours
Body temperature	Periodic assessment of participant body temperature during both experimental sessions.	Approximately every 60 minutes for each experimental session

Collaborators and Investigators

• Sponsor: Lykos Therapeutics
• Investigators: Study Director: Michael M Mithoefer, MD, Lykos Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2011
• Primary Completion (Actual): August 5, 2022
• Study Completion (Actual): August 5, 2022

Study Registration Dates

• First Submitted: July 19, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (Estimated): July 28, 2011

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: MDMA; mood; subjective effects; interpersonal closeness
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Membrane Transport Modulators; Psychotropic Drugs; Adrenergic Agents; Neurotransmitter Uptake Inhibitors; Adrenergic Uptake Inhibitors; Serotonin Agents; Hallucinogens; N-Methyl-3,4-methylenedioxyamphetamine
• Other Study ID Numbers: MT-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No