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

NCT ID: NCT01404754

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-09
• Study Completion Date: 2022-08-05

Brief Summary

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.

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.

Conditions

Psychological Effects of Study Drug

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Lactose (Inactive Placebo)

Participant receives inactive placebo during day-long experimental session.

Group Type: PLACEBO_COMPARATOR

Lactose (inactive placebo)

Intervention Type: DRUG

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.

3,4-methylenedioxymethamphetamine

Participant receives 120 mg midomafetamine HCl possibly followed by 40 mg midomafetamine HCl during a day-long experimental session.

Group Type: ACTIVE_COMPARATOR

midomafetamine HCl

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

placebo; midomafetamine; MDMA; 3,4-methylenedioxymethamphetamine; MDMA HCl

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lykos Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael M Mithoefer, MD

Role: STUDY_DIRECTOR

Lykos Therapeutics

Locations

Aguazul Bluewater, Inc.

Boulder, Colorado, United States

Santa Fe MDMA Therapy Training, LLC

Santa Fe, New Mexico, United States

Zen Therapeutic Solutions

Mt. Pleasant, South Carolina, United States

Countries

United States

Other Identifiers

MT-1

Identifier Type: -

Identifier Source: org_study_id