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

NCT ID: NCT02427568

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-14
• Study Completion Date: 2018-05-17

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.

Detailed Description

This Phase 2 pilot study is a randomized, double-blind, placebo-controlled study in 18 participants comparing the effects of MDMA-assisted therapy vs. placebo with therapy. Thirteen participants were randomized to the active dose condition of 125 mg of MDMA HCl (plus an optional supplemental dose of 62.5 mg MDMA HCl) with therapy and five participants were randomized to the placebo with therapy condition. The study consisted of two blinded experimental sessions of MDMA-assisted therapy or placebo with therapy, each session lasting six to eight hours and scheduled two to four weeks apart. Each participant was unblinded one month after their second experimental session in Stage 1. After unblinding, participants receiving MDMA were to complete a third open-label experimental session of MDMA-assisted therapy and participants who originally received placebo had the opportunity to cross over to open-label Stage 2 and receive active MDMA-assisted therapy in 3 sessions.

The primary objective of the study is to assess changes in trait anxiety in subjects receiving active dose MDMA compared to those receiving placebo as measured by State-Trait Anxiety Index (STAI) Trait scores from Baseline to the Primary Endpoint (one month after the second experimental session).

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo with therapy

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Therapy

Intervention Type: BEHAVIORAL

Manualized therapy

MDMA-assisted therapy (125 mg)

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.

Group Type: EXPERIMENTAL

Midomafetamine HCl

Intervention Type: DRUG

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

Therapy

Intervention Type: BEHAVIORAL

Manualized therapy

Interventions

Midomafetamine HCl

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Therapy

Manualized therapy

Intervention Type: BEHAVIORAL

Other Intervention Names

3,4-methylenedioxymethamphetamine; Midomafetamine; MDMA; Inactive placebo

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 past, 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
• Have used "Ecstasy" (material represented as containing MDMA) at least once within twelve months of enrollment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lykos Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Wolfson, MD

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Locations

Offices of Philip Wolfson MD

San Anselmo, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 33235285 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

MDA-1

Identifier Type: -

Identifier Source: org_study_id