Psychopharmacology
June 1, 2024
Paul S Soliman, Dallece E Curley, Christy Capone et al.
22 citations
A systematic review of randomized placebo-controlled trials using psychedelics (MDMA, psilocybin, LSD, DMT/ayahuasca) with assisted therapy for psychiatric disorders found that traditional placebos are inadequate for controlling expectancy biases. Sixteen studies were reviewed. The authors suggest that active placebos and methods to limit personnel unblinding are important for future trial designs to improve internal validity and reduce response bias.
Journal of psychopharmacology (Oxford, England)
December 1, 2023
Brian J Gully, Erica Eaton, Christy Capone et al.
12 citations
PTSD and alcohol use disorder often co-occur in trauma-exposed patients, creating a cycle where PTSD symptoms drive heavy drinking and vice versa. No FDA-approved medications exist specifically for this comorbidity; patients receive treatments approved for each disorder separately or off-label, which have limited efficacy. Emerging research suggests the psychedelic drug MDMA, used with psychotherapy, may be effective. This review examines current pharmacotherapies and MDMA-integrative psychotherapy for PTSD and AUD both individually and together, and discusses future directions for psychedelic-integrative therapy in treating this comorbidity.
CNS drugs
July 10, 2025
Eric A Miller, Christy Capone, Erica Eaton et al.
4 citations
Psychedelics have been investigated as a treatment for alcohol use disorder since the 1950s, with over a dozen clinical trials of LSD and recent trials of psilocybin and ayahuasca. Observational studies consistently show promising results, but placebo-controlled trials have produced inconsistent outcomes and methodologies. This review characterizes foundational studies, emphasizing key design factors such as the presence of a placebo (e.g., ephedrine, dextroamphetamine, diphenhydramine, or low-dose LSD) and non-pharmacological factors like treatment setting and psychotherapy. It also examines candidate mechanisms of action through a biopsychosocial lens, spanning cellular neuroplasticity, cognitive neuroscience, subjective experience, and social connection, highlighting findings on efficacy and potential mechanisms to guide future research.
Contemporary clinical trials communications
October 1, 2024
Erica Eaton, Christy Capone, Brian J Gully et al.
2 citations
Posttraumatic stress disorder and alcohol use disorder frequently co-occur and lead to more severe symptoms, higher suicide risk, and poorer treatment outcomes. MDMA-assisted therapy shows promise; the FDA designated it a Breakthrough Therapy for PTSD based on six Phase 2 trials. This manuscript describes the design of the first open-label trial of MDMA-AT for military veterans with both PTSD and AUD, enrolling 12 participants. The study includes neuroimaging and biomarker measures to assess brain changes and neuroinflammation before and after treatment. The authors detail the complex clinical and regulatory processes involved in setting up the trial, aiming to establish standardized protocols and outcomes for future FDA approval.