Clinical trial NCT02427568: MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety
Keywords: Anxiety
MDMA
Life-threatening illness
Therapy
midomafetamine
Lead sponsor: Lykos Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-04-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change in State Trait Anxiety Inventory (STAI) Trait Score From Baseline to Primary Endpoint
timeFrame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)
measure: Primary Endpoint STAI Trait Score
timeFrame: One month post-2nd experimental session
Secondary outcomes:
measure: Change in STAI State Score From Baseline to Primary Endpoint
timeFrame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)
measure: Change in Beck Depression Inventory-II (BDI-II) Score From Baseline to Primary Endpoint
timeFrame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)
measure: Change in Global Assessment of Functioning (GAF) Score From Baseline to Primary Endpoint
timeFrame: Baseline (3 months from enrollment) to Primary Endpoint (one month post 2nd experimental session)
measure: Change in MADRS Score From Baseline to Primary Endpoint
timeFrame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)
measure: Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Primary Endpoint
timeFrame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)
measure: Change in Posttraumatic Growth Inventory (PTGI) From Baseline to Primary Endpoint
timeFrame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)
measure: Change in Functional Assessment of Chronic Illness Therapy Scale (FACIT) From Baseline to Primary Endpoint
timeFrame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)
measure: Change in Death Attitudes Profile (DAP) From Baseline to Primary Endpoint
timeFrame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)
measure: Change in Self-Compassion Scale (SCS) From Baseline to Primary Endpoint
timeFrame: Baseline (3 months from enrollment) to Primary Endpoint (one month post-2nd experimental session)
Other outcomes:
Locations:
city: San Anselmo
country: United States
facility: Offices of Philip Wolfson MD
state: California
Study officials:
affiliation: Private Practice
name: Philip Wolfson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.