NCT01404754

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Lykos Therapeutics · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2011-04-09
• Primary completion: 2022-08-05
• Completion: 2022-08-05
• First posted: 2011-07-28
• Last updated: 2024-10-31

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study