CompletedPhase 1MDMA
Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers
Sponsored by Lykos Therapeutics
NCT ID
NCT01404754
Target Enrollment
107 participants
Start Date
2011-04-09
Est. Completion
2022-08-05
About This Study
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 Studied
Interventions
- •Lactose (inactive placebo)
- •midomafetamine HCl
Eligibility
Age:21 Years - N/A
Healthy Volunteers:Yes
View full 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
Study Locations (3)
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