Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers

Lykos Therapeutics107 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Interventions

Lactose (inactive placebo)DRUG

Placebo in an equivalent weight to midomafetamine HCl will be administered in identical appearing capsules during one of two experimental sessions. An equivalent to the initial and supplemental dose will exist.

midomafetamine HClDRUG

120 mg midomafetamine HCl will be administered in opaque capsules at the outside of one of two experimental sessions, and upon mutual agreement between the investigator and participant, 40 mg may be administered 1.5 to 2.5 hours later.

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Profile of Mood States (POMS)

Assesses current mood state

Time frame: Experimental session approximately six hours after drug administration

Profile of Mood States (POMS)

Assesses current mood state

Time frame: Day prior to each experimental session

Profile of Mood States (POMS)

Assesses current mood state

Time frame: Day after each experimental session

Secondary Outcomes

Interpersonal closeness measure

Visual analog scale assessing emotional closeness to self and four other targets

Time frame: Day prior to experimental session

Interpersonal closeness measure

Visual analog scale assessing emotional closeness to self and four other targets

Time frame: Day of experimental session approximately six hours post-drug administration

Interpersonal closeness measure

Visual analog scale assessing emotional closeness to self and four other targets

Time frame: Day after each experimental session

Brief Symptom Inventory (BSI)

Self-report measure assessing psychiatric symptoms

Time frame: Day prior to each experimental session

Brief Symptom Inventory (BSI)

Self-report measure assessing psychiatric symptoms

Time frame: Day of experimental session prior to drug administration

Brief Symptom Inventory (BSI)

Self-report measure assessing psychiatric symptoms

Time frame: Day of experimental session approximately five to six hours after drug administration

Brief Symptom Inventory (BSI)

Self-report measure assessing psychiatric symptoms

Time frame: Day after each experimental session

Columbia Suicide Severity Rating Scale (adapted C-SSRS)

Clinician-administered measure of suicide risk

Time frame: Day prior to each experimental session

Neuroticism Extroversion Openness Personality Inventory

Self-report measure of five personality factors; Neuroticism, extroversion, openness to experience, conscientiousness and agreeableness

Time frame: At baseline

Neuroticism Extroversion Openness Personality Inventory

Self-report measure of five personality factors; Neuroticism, extroversion, openness to experience, conscientiousness and agreeableness

Time frame: Two months after the second experimental session

Columbia Suicide Severity Rating Scale (adapted C-SSRS)

Clinician-administered measure of suicide risk

Time frame: Day after each experimental session

Columbia Suicide Severity Rating Scale (adapted C-SSRS)

Clinician-administered measure of suicide risk

Time frame: One month after the second experimental session

Columbia Suicide Severity Rating Scale (adapted C-SSRS)

Clinician-administered measure of suicide risk

Time frame: Two months after the second experimental session

Columbia Suicide Severity Rating Scale (adapted C-SSRS)

Clinician-administered measure of suicide risk

Time frame: Day six and 12 of telephone contact after second experimental session

Columbia Suicide Severity Rating Scale (adapted C-SSRS)

Clinician-administered measure of suicide risk

Time frame: Day of each experimental session prior to drug administration

Columbia Suicide Severity Rating Scale (adapted C-SSRS)

Clinician-administered measure of suicide risk

Time frame: Day of each experimental session approximately five to six hours after drug administration

Blood pressure (SBP/DBP)

Periodic assessment of participant blood pressure during both experimental sessions.

Time frame: Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours

Heart rate (pulse)

Periodic assessment of participant pulse during both experimental sessions.

Time frame: Throughout each experimental session, every 15 minutes for 6 hours, then every 30 minutes for 2 hours

Body temperature

Periodic assessment of participant body temperature during both experimental sessions.

Time frame: Approximately every 60 minutes for each experimental session

Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes