The effects of MDMA-assisted therapy on alcohol and substance use in a phase 3 trial for treatment of severe PTSD.
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 (PlaceboTherapy). Adult participants with severe PTSD (n 90) were randomized to three blinded trauma-focused therapy sessions with either MDMA-AT or PlaceboTherapy. 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. There were no treatment group differences in AUDIT or DUDIT scores at baseline. Compared to Placebotherapy, 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 Hedges g .45). Changes in DUDIT scores were not significantly different between treatment groups. 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.