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

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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 (plus an optional supplemental dose of 62.5 mg MDMA) with therapy and five participants were randomized to the placebo with therapy condition. The study will consist 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 will be unblinded one month after their second experimental session in Stage 1. After unblinding, participants receiving placebo will have the opportunity to cross over to open-label Stage 2 and receive active MDMA. Only subjects who receive active dose MDMA will complete an optional third open-label experimental session.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Multidisciplinary Association for Psychedelic Studies
• Treatments: N-Methyl-3,4-methylenedioxyamphetamine

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