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

NCT01404754 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2024-10-31

No results posted yet for this study

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.

Conditions

  • Psychological Effects of Study Drug

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Michael M Mithoefer, MD · Lykos Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-09
Primary Completion
2022-08-05
Completion
2022-08-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01404754 on ClinicalTrials.gov