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

NCT01404754 | Completed Phase 1 FDA Drug

• 1 other identifier: MT-1
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 3

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.

Conditions

Psychological Effects of Study Drug

Keywords

MDMA; mood; subjective effects; interpersonal closeness

Outcome Measures

Primary Outcomes (3)

• Profile of Mood States (POMS)

  Assesses current mood state

  Experimental session approximately six hours after drug administration

• Profile of Mood States (POMS)

  Assesses current mood state

  Day prior to each experimental session

• Profile of Mood States (POMS)

  Assesses current mood state

  Day after each experimental session

Secondary Outcomes (19)

• Interpersonal closeness measure

  Day prior to experimental session

• Interpersonal closeness measure

  Day of experimental session approximately six hours post-drug administration

• Interpersonal closeness measure

  Day after each experimental session

• Brief Symptom Inventory (BSI)

  Day prior to each experimental session

• Brief Symptom Inventory (BSI)

  Day of experimental session prior to drug administration

Study Arms (2)

Lactose (Inactive Placebo)

PLACEBO COMPARATOR

Participant receives inactive placebo during day-long experimental session.

Drug: Lactose (inactive placebo)

3,4-methylenedioxymethamphetamine

ACTIVE COMPARATOR

Participant receives 120 mg midomafetamine HCl possibly followed by 40 mg midomafetamine HCl during a day-long experimental session.

Drug: midomafetamine HCl

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.

Also known as: placebo

Lactose (Inactive Placebo)

midomafetamine HCl DRUG

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.

Also known as: midomafetamine, MDMA, 3,4-methylenedioxymethamphetamine, MDMA HCl

3,4-methylenedioxymethamphetamine

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 medical or psychiatric history must not have any current or past diagnosis that would be considered a risk to participation in the study

Sponsors & Collaborators

• Lykos Therapeutics: lead

Study Sites (3)

Aguazul Bluewater, Inc.

Boulder, Colorado, 80304, United States

Location

Santa Fe MDMA Therapy Training, LLC

Santa Fe, New Mexico, 87508, United States

Location

Zen Therapeutic Solutions

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Interventions

Lactose; N-Methyl-3,4-methylenedioxyamphetamine

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Michael M Mithoefer, MD

  Lykos Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 28, 2011
• Study Start: April 9, 2011
• Primary Completion: August 5, 2022
• Study Completion: August 5, 2022
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

US (3)