CompletedPhase 1

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

United States107 participantsStarted 2011-04-09

Plain-language 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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 re…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Profile of Mood States (POMS)

Timeframe: Experimental session approximately six hours after drug administration

Profile of Mood States (POMS)

Timeframe: Day prior to each experimental session

Profile of Mood States (POMS)

Timeframe: Day after each experimental session

Trial details

NCT IDNCT01404754

SponsorResilient Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-05

View on ClinicalTrials.gov More Psychological Effects of Study Drug trials

Plain-language summary

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.