Status:
COMPLETED
Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers
Lead Sponsor:
Lykos Therapeutics
Conditions:
Psychological Effects of Study Drug
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief 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, em...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 9 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2022
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT01404754
Start Date
April 9 2011
End Date
August 5 2022
Last Update
October 31 2024
Active Locations (3)
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1
Aguazul Bluewater, Inc.
Boulder, Colorado, United States, 80304
2
Santa Fe MDMA Therapy Training, LLC
Santa Fe, New Mexico, United States, 87508
3
Zen Therapeutic Solutions
Mt. Pleasant, South Carolina, United States, 29464