THE EFFECTS OF MDMA-ASSISTED THERAPY ON ALCOHOL AND SUBSTANCE USE IN A PHASE 3 TRIAL FOR TREATMENT OF SEVERE PTSD
Christopher R. Nicholas, Julie B. Wang, Allison R. Coker, Jennifer Mitchell, Sukhpreet Klaire, B. Yazar-Klosinski, A. Emerson, Randy Brown, R. Doblin
Drug and Alcohol Dependence February 1, 2022 DOI: 10.1016/j.drugalcdep.2022.109356 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Placebo-controlled Peer reviewed |
|---|---|
| Sample size | 90 |
| Population | Adults with severe PTSD and mild to moderate alcohol or cannabis use disorder |
| Interventions | MDMA-assisted therapy placebo plus therapy |
| Topics | MDMA PTSD |
| Citations | 67 |
| Key findings | MDMA-assisted therapy led to a significantly greater reduction in hazardous alcohol use compared to placebo plus therapy, with no increase in illicit drug use. |
Abstract
Background: Post-traumatic stress disorder (PTSD) is commonly associated with alcohol and substance use disorders (ASUD). A randomized, placebo-controlled, phase 3 trial demonstrated the safety and efficacy of MDMA-assisted therapy (MDMA-AT) for the treatment of severe PTSD. This analysis explores patterns of alcohol and substance use in patients receiving MDMA-AT compared to placebo plus therapy (Placebo+Therapy).
Methods: Adult participants with severe PTSD (n = 90) were randomized to three blinded trauma-focused therapy sessions with either MDMA-AT or Placebo+Therapy. Eligible participants met DSM-5 criteria for severe PTSD and could meet criteria for mild (current) or moderate (early remission) alcohol or cannabis use disorder; other SUDs were excluded. The current analyses examined outcomes on standardized measures of hazardous alcohol (i.e., Alcohol Use Disorder Identification Test; AUDIT) and drug (i.e., Drug Use Disorder Identification Test; DUDIT) use at baseline prior to randomization and at study termination.
Results: There were no treatment group differences in AUDIT or DUDIT scores at baseline. Compared to Placebo+therapy, MDMA-AT was associated with a significantly greater reduction in mean (SD) AUDIT change scores (Δ = −1.02 (3.52) as compared to placebo (Δ = 0.40 (2.70), F (80, 1) = 4.20, p = 0.0436; Hedge’s g= .45). Changes in DUDIT scores were not significantly different between treatment groups.
Conclusions: MDMA-AT for severe PTSD may also lead to subclinical improvements in alcohol use. MDMA-AT does not appear to increase risk of illicit drug use. These data provide preliminary evidence to support the development of MDMA-AT as an integrated treatment for co-occurring PTSD and ASUD.
Comparable studies
Other randomized controlled trials on MDMA for PTSD, most cited first.