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.
Topic Anxiety
Palliative Care
Country United States of America
Visit trial
Status
Completed
Results Published
No
Start date
04 January 2015
End date
07 January 2018
Chance of happening
100%
Phase
Phase II
Design
Blinded
Type
Interventional
Generation
First
Participants
18
Sex
All
Age
18- 99
Therapy
Yes
Trial Details
Individuals facing, or who have faced, a life-threatening illness contend with more than just the physical symptoms of their condition and may experience anxiety, depression, anger, and despair that can exacerbate their distress. Research suggests that diagnosis of, and living with a life-threatening illness can result in symptoms similar to those seen in posttraumatic stress disorder (PTSD). 3,-4-methylenedioxymethamphetamine (MDMA) is a monoamine releaser with a unique pharmacological profile that include decreased feelings of fear, increased positive mood and increased interpersonal trust. Findings from clinical trials in people with PTSD and anecdotal reports suggest that MDMA-assisted psychotherapy may assist people who have anxiety related to having a life-threatening illness. 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 MDMA will complete a third open-label experimental session of MDMA-assisted therapy and participants who originally received placebo will have 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).NCT Number NCT02427568
Sponsors & Collaborators
MAPSMAPS stands for Multidisciplinary Association for Psychedelic Studies, it's the front runner in making psychedelics a legal way to use (and improve) in therapy.
Papers
Facing death, returning to life: A qualitative analysis of MDMA-assisted therapy for anxiety associated with life-threatening illnessThis qualitative interview study (n=6 out of 13) on MDMA-assisted therapy for end-of-life anxiety, conducted three months after dosing (3x 125mg), highlights the psychological processes participants went through. Treatment outcomes included better management of medical symptoms and relationship to illness, reduction in psychological symptoms, improved quality of life, being more present, and feeling more resourced.
Measures Used
State-Trait Anxiety InventoryThe State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. The STAI measures two types of anxiety – state anxiety, anxiety about an event, and trait anxiety, anxiety level as a personal characteristic.
Beck Depression Inventory
The Beck Depression Inventory (BDI) contains 21 self-report items, completed using a multiple-choice format. Scores range from 0-63 with higher scores associated with more severe depression.
Columbia-Suicide Severity Rating Scale
The Columbia-Suicide Severity Rating Scale (CSSRS) is a suicidal ideation and behaviour rating scale created by researchers at Columbia University, University of Pennsylvania, University of Pittsburgh and New York University to evaluate suicide risk
Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.