MDMA-assisted Psychotherapy for Anxiety Associated With a Life-threatening Illness
This Phase II pilot study is a randomized, double-blind, placebo-controlled study in 18 participants comparing the effects of MDMA-assisted therapy vs. placebo with therapy.
Detailed Description
The trial tests whether MDMA-assisted therapy reduces anxiety associated with life-threatening illness compared with placebo plus manualised therapy.
Eighteen participants were randomised (13 active, 5 placebo) to two blinded experimental sessions of MDMA (125 mg with optional 62.5 mg supplemental) or inactive placebo, each session lasting six to eight hours and scheduled two to four weeks apart.
Three preparatory non-drug therapy sessions precede the first experimental session; each medication session is followed by three integrative therapy sessions. After unblinding, active participants received a third open-label MDMA session and placebo participants could cross over to active treatment.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
MDMA-assisted therapy
experimentalTwo blinded MDMA-assisted therapy sessions (125 mg, optional 62.5 mg supplemental) with manualised therapy; open-label third session after unblinding for active participants.
Interventions
- MDMA125 - 187.5 mgvia Oral• two sessions• 2 doses total
Optional supplemental dose 62.5 mg given 1.5–2.5 h after initial; open-label third session offered after unblinding.
- Placebovia Oral• two sessions• 2 doses total
Inactive placebo; optional supplemental inactive placebo 1.5–2.5 h after initial.
Placebo with therapy
inactiveManualised therapy with inactive placebo administered on two blinded experimental sessions; option to cross over to open-label MDMA sessions.
Interventions
- Placebovia Oral• two sessions• 2 doses total
Inactive placebo; optional supplemental inactive placebo 1.5–2.5 h after initial.
Participants
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.
Study Details
- StatusCompleted
- PhasePhase II
- Typeinterventional
- DesignRandomizedquadruple Blind
- Target Enrollment18 participants
- TimelineStart: 2015-01-04End: 2018-01-07
- Compounds
- Topic