Phase 2
Completed N=18
MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness
Source: ClinicalTrials.gov NCT02427568 ↗Enrolled (actual)
18
Serious AEs
5.6%
Results posted
Aug 2021
Primary outcomePrimary: Change in State Trait Anxiety Inventory (STAI) Trait Score From Baseline to Primary Endpoint — -8.8; -23.5 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in State Trait Anxiety Inventory (STAI) Trait Score From Baseline to Primary Endpoint |
-8.8; -23.5 | — |
| PRIMARY Primary Endpoint STAI Trait Score |
48.6; 38.9 | — |
| SECONDARY Change in STAI State Score From Baseline to Primary Endpoint |
-6.0; -22.1 | — |
| SECONDARY Change in Beck Depression Inventory-II (BDI-II) Score From Baseline to Primary Endpoint |
-14.6; -20.9 | — |
| SECONDARY Change in Global Assessment of Functioning (GAF) Score From Baseline to Primary Endpoint |
3.0; 6.6 | — |
| SECONDARY Change in MADRS Score From Baseline to Primary Endpoint |
-7.0; -10.5 | — |
| SECONDARY Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Primary Endpoint |
-0.2; -3.6 | — |
| SECONDARY Change in Posttraumatic Growth Inventory (PTGI) From Baseline to Primary Endpoint |
-2.6; 12.9 | — |
| SECONDARY Change in Functional Assessment of Chronic Illness Therapy Scale (FACIT) From Baseline to Primary Endpoint |
2.8; 1.4; -2.0; 0.8; 1.0; 1.6 | — |
| SECONDARY Change in Death Attitudes Profile (DAP) From Baseline to Primary Endpoint |
-0.6; -0.1; -1.1; 0; 0.2; 0.1 | — |
| SECONDARY Change in Self-Compassion Scale (SCS) From Baseline to Primary Endpoint |
-0.04; 0.4 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02427568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.