Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers
Completed · Phase 1 · Has a placebo group
Conditions studied: Psychological Effects of Study Drug
In brief
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.
Key facts
- Study ID
- NCT01404754
- Run by
- Resilient Pharmaceuticals
- People needed
- 107
- Starts
- 2011-04-09
- Expected to finish
- 2022-08-05
- Last updated by the study team
- 2024-10-31
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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