Clinical trial NCT01404754: Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers
Official title: A Phase 1 Placebo-Controlled, Double-Blind Crossover Study to Assess Psychological Effects of MDMA When Administered to Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psychological Effects of Study Drug
Keywords: MDMA
mood
subjective effects
interpersonal closeness
Lead sponsor: Lykos Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-07-28
Enrollment: 107
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Profile of Mood States (POMS)
timeFrame: Experimental session approximately six hours after drug administration
measure: Profile of Mood States (POMS)
timeFrame: Day prior to each experimental session
measure: Profile of Mood States (POMS)
timeFrame: Day after each experimental session
Secondary outcomes:
measure: Interpersonal closeness measure
timeFrame: Day prior to experimental session
measure: Interpersonal closeness measure
timeFrame: Day of experimental session approximately six hours post-drug administration
measure: Interpersonal closeness measure
timeFrame: Day after each experimental session
measure: Brief Symptom Inventory (BSI)
timeFrame: Day prior to each experimental session
measure: Brief Symptom Inventory (BSI)
timeFrame: Day of experimental session prior to drug administration
measure: Brief Symptom Inventory (BSI)
timeFrame: Day of experimental session approximately five to six hours after drug administration
measure: Brief Symptom Inventory (BSI)
timeFrame: Day after each experimental session
measure: Columbia Suicide Severity Rating Scale (adapted C-SSRS)
timeFrame: Day prior to each experimental session
measure: Neuroticism Extroversion Openness Personality Inventory
timeFrame: At baseline
measure: Neuroticism Extroversion Openness Personality Inventory
timeFrame: Two months after the second experimental session
measure: Columbia Suicide Severity Rating Scale (adapted C-SSRS)
timeFrame: Day after each experimental session
measure: Columbia Suicide Severity Rating Scale (adapted C-SSRS)
timeFrame: One month after the second experimental session
measure: Columbia Suicide Severity Rating Scale (adapted C-SSRS)
timeFrame: Two months after the second experimental session
measure: Columbia Suicide Severity Rating Scale (adapted C-SSRS)
timeFrame: Day six and 12 of telephone contact after second experimental session
measure: Columbia Suicide Severity Rating Scale (adapted C-SSRS)
timeFrame: Day of each experimental session prior to drug administration
measure: Columbia Suicide Severity Rating Scale (adapted C-SSRS)
timeFrame: Day of each experimental session approximately five to six hours after drug administration
measure: Blood pressure (SBP/DBP)
timeFrame: Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours
measure: Heart rate (pulse)
timeFrame: Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours
measure: Body temperature
timeFrame: Approximately every 60 minutes for each experimental session
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Aguazul Bluewater, Inc.
state: Colorado
city: Santa Fe
country: United States
facility: Santa Fe MDMA Therapy Training, LLC
state: New Mexico
city: Mount Pleasant
country: United States
facility: Zen Therapeutic Solutions
state: South Carolina
Study officials:
affiliation: Lykos Therapeutics
name: Michael M Mithoefer, MD
role: STUDY_DIRECTOR
References: