Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers
- Conditions
- Psychological Effects of Study Drug
- Interventions
- Registration Number
- NCT01404754
- Lead Sponsor
- Lykos Therapeutics
- 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, 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.
- 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 more effectively be used within a therapeutic context, as with people with PTSD. Participants will be healthy volunteers who have completed a program training them in conducting MDMA-assisted psychotherapy. In this randomized, double blind study, subjects will receive placebo and MDMA during two sessions scheduled at least two days apart in a psychotherapy setting. Mood, self-reported interpersonal closeness, psychological symptoms, blood pressure, heart rate and body temperature will be measured, and personality will be measured prior to the first therapy-like session and two months after the second session.
The study will follow a cross-over design, meaning that all participants will receive both MDMA and placebo, with order of session randomly assigned. Study participants will have a preparatory session prior to each experimental session and an integrative session after each session. The researchers will contact them via telephone one and two months after the second experimental session. By comparing changes in mood, feelings of emotional closeness to the self and others and psychological symptoms after placebo and after MDMA, the investigators hope to learn something about the effects of MDMA on mood, subjective experience and the way we think and feel about others.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Lactose (Inactive Placebo) Lactose (inactive placebo) Participant receives inactive placebo during day-long experimental session. 3,4-methylenedioxymethamphetamine midomafetamine HCl Participant receives 120 mg midomafetamine HCl possibly followed by 40 mg midomafetamine HCl during a day-long experimental session.
- Primary Outcome Measures
Name Time Method Profile of Mood States (POMS) Day after each experimental session Assesses current mood state
- Secondary Outcome Measures
Name Time Method Interpersonal closeness measure Day after each experimental session Visual analog scale assessing emotional closeness to self and four other targets
Blood pressure (SBP/DBP) Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours Periodic assessment of participant blood pressure during both experimental sessions.
Heart rate (pulse) Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours Periodic assessment of participant pulse during both experimental sessions.
Brief Symptom Inventory (BSI) Day after each experimental session Self-report measure assessing psychiatric symptoms
Columbia Suicide Severity Rating Scale (adapted C-SSRS) Day of each experimental session approximately five to six hours after drug administration Clinician-administered measure of suicide risk
Neuroticism Extroversion Openness Personality Inventory Two months after the second experimental session Self-report measure of five personality factors; Neuroticism, extroversion, openness to experience, conscientiousness and agreeableness
Body temperature Approximately every 60 minutes for each experimental session Periodic assessment of participant body temperature during both experimental sessions.
Trial Locations
- Locations (3)
Santa Fe MDMA Therapy Training, LLC
🇺🇸Santa Fe, New Mexico, United States
Aguazul Bluewater, Inc.
🇺🇸Boulder, Colorado, United States
Zen Therapeutic Solutions
🇺🇸Mount Pleasant, South Carolina, United States