MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness

NCT02427568 | Completed Phase 2 Results

• 1 other identifier: MDA-1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with anxiety associated with a life-threatening illness. The main question it aims to answer is: Does anxiety decrease in people receiving two sessions of MDMA-assisted therapy? Researchers will compare people receiving placebo with therapy to people receiving MDMA-assisted therapy.

• Participants will undergo three non-drug preparatory therapy sessions before their first blinded session of MDMA or placebo with therapy.
• Each medication session will be followed by three non-drug integrative therapy sessions.
• After the second blinded medication session, participants receiving MDMA will complete a third open-label medication session.
• Participants who received placebo will be given the option to crossover and receive three sessions of assisted therapy.

Conditions

Anxiety

Keywords

Anxiety; MDMA; Life-threatening illness; Therapy; midomafetamine

Outcome Measures

Primary Outcomes (2)

• Change in State Trait Anxiety Inventory (STAI) Trait Score From Baseline to Primary Endpoint

  The State-Trait Anxiety Inventory (STAI) is a 20-item self-report measure of intensity of anxiety. Each item consists of a 4-point Likert rating scale ranging from 1 ('Not at all') to 4 ('Very Much So'), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80. The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure was intended to target those anxiety symptoms that are chronic and pervasive.

  Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)

• Primary Endpoint STAI Trait Score

  The State-Trait Anxiety Inventory (STAI) is a 20-item self-report measure of intensity of anxiety. Each item consists of a 4-point Likert rating scale ranging from 1 ('Not at all') to 4 ('Very Much So'), with higher scores indicating greater anxiety. Items were summed for a total score that ranged from 20 to 80. The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The use of the trait subscale as the primary outcome measure is intended to target those anxiety symptoms that are chronic and pervasive.

  One month post-2nd experimental session

Secondary Outcomes (9)

• Change in STAI State Score From Baseline to Primary Endpoint

  Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)

• Change in Beck Depression Inventory-II (BDI-II) Score From Baseline to Primary Endpoint

  Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)

• Change in Global Assessment of Functioning (GAF) Score From Baseline to Primary Endpoint

  Baseline (3 months from enrollment) to Primary Endpoint (one month post 2nd experimental session)

• Change in MADRS Score From Baseline to Primary Endpoint

  Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)

• Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Primary Endpoint

  Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)

Study Arms (2)

Placebo with therapy

PLACEBO COMPARATOR

Inactive placebo administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by (optional) inactive placebo supplemental dose.

Drug: Placebo; Behavioral: Therapy

MDMA-assisted therapy (125 mg)

EXPERIMENTAL

125 mg midomafetamine HCl administered on 2 blinded experimental sessions scheduled 2 to 4 weeks apart. Initial dose possibly followed 1.5 to 2.5 hours later by a (optional) supplemental dose of 62.5 mg.

Drug: Midomafetamine HCl; Behavioral: Therapy

Interventions

Midomafetamine HCl DRUG

Two sessions of MDMA-assisted therapy lasting six to eight hours, scheduled two to four weeks apart.

Also known as: 3,4-methylenedioxymethamphetamine, Midomafetamine, MDMA

MDMA-assisted therapy (125 mg)

Placebo DRUG

Two sessions of placebo with therapy lasting six to eight hours, scheduled two to four weeks apart.

Also known as: Inactive placebo

Placebo with therapy

Therapy BEHAVIORAL

Manualized therapy

MDMA-assisted therapy (125 mg); Placebo with therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with life-threatening cancer or non-dementing neurological illness, which can be ongoing or in remission, but with a possibility of recurrence
• Prognosis of at least nine months life expectancy from the time of screening
• Have anxiety as a result of facing their illness
• Are at least 18 years old
• Are willing to refrain from taking any psychiatric medications during the study period;
• Are willing to commit to medication dosing, experimental sessions, follow-up sessions, and to complete evaluation instruments
• Are willing to remain overnight at the study site after each experimental session until after the integrative session occurring the next morning
• Must sign a medical release for the investigators to communicate directly with their therapist and doctors;
• Are willing to select up to three observers who will complete observer measures of subject attitudes and behavior
• Negative pregnancy test if able to bear children and agree to use effective birth control
• Are proficient in speaking and reading English
• Agree to have all psychotherapy sessions recorded to audio/video.

You may not qualify if:

• Are pregnant or nursing, or if a woman who can have children, those who are not practicing an effective means of birth control;
• Weigh less than 48 kg
• Are abusing illegal drugs
• Are 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
• Have used "Ecstasy" (material represented as containing MDMA) at least once within twelve months of enrollment.

Sponsors & Collaborators

• Lykos Therapeutics: lead

Study Sites (1)

Offices of Philip Wolfson MD

San Anselmo, California, 94960, United States

Location

Related Publications (1)

• Wolfson PE, Andries J, Feduccia AA, Jerome L, Wang JB, Williams E, Carlin SC, Sola E, Hamilton S, Yazar-Klosinski B, Emerson A, Mithoefer MC, Doblin R. MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study. Sci Rep. 2020 Nov 24;10(1):20442. doi: 10.1038/s41598-020-75706-1.

  PMID: 33235285 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Lykos Therapeutics

trialdata@lykospbc.com

877-627-7722

Study Officials

• Philip Wolfson, MD

  Private Practice

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 28, 2015
• Study Start: May 14, 2015
• Primary Completion: April 25, 2017
• Study Completion: May 17, 2018
• Last Updated: June 5, 2025
• Results First Posted: August 2, 2021

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data and study-related documents will be available when all participants have completed the study, and when data has been quality checked and locked.
• Access Criteria: Interested persons should correspond with the central contact for the multisite study.

Locations

US (1)