Contemporary clinical trials communications
December 1, 2019
Brittany O'Brien, Charles E Green, Rayan Al-Jurdi et al.
10 citations
Over eleven million U.S. Veterans are 65 or older, and nearly 20% of that group experiences clinically significant depression. Existing medications often work poorly for late-life depression, especially when it is treatment-resistant. Ketamine offers a potentially rapid-acting option, but few studies have tested it in older adults. This ongoing trial uses an adaptive randomization design to compare the safety, tolerability, efficacy, and durability of three different low doses of intravenous ketamine against a single dose of an active placebo (midazolam) in older depressed veterans. As the study proceeds, Bayesian adaptive randomization shifts the odds of assignment toward the more promising dose conditions.
Contemporary clinical trials communications
February 1, 2025
Jessica L Maples-Keller, Boadie W Dunlop, Barbara O Rothbaum
5 citations
An open-label pilot trial will test whether 100 mg of MDMA combined with massed exposure therapy—daily sessions for two weeks—is feasible for treating PTSD. The authors argue that combining MDMA with a gold-standard exposure treatment has translational support and strong dissemination potential. The study aims to enroll at least 15 adults with PTSD over two years to develop a treatment manual, which will later be tested in a randomized, placebo-controlled trial. This approach could improve the ability to treat PTSD.
Contemporary clinical trials communications
August 1, 2024
L A Morland, D Perivoliotis, T R Wachsman et al.
4 citations
PTSD harms both individuals and their intimate relationships, and veteran couples face extra strain from deployment and reintegration. Cognitive-Behavioral Conjoint Therapy (CBCT) and its brief version (bCBCT) consistently reduce PTSD symptoms but have variable effects on relationship functioning. This open-label pilot study tests whether adding MDMA-assisted therapy to bCBCT improves both PTSD and relationship outcomes. Eight veterans with PTSD and their partners (16 people total) will receive bCBCT plus two MDMA sessions and two couple emotion-focused integration sessions. This is the first trial of MDMA-assisted bCBCT in U.S. military veterans and partners, aiming to develop a scalable treatment model for the VA healthcare system.
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.
Contemporary clinical trials communications
June 1, 2025
Daniel Kriegman, Rachel Pelletier, Caroline Griggs et al.
A 4-week treatment protocol incorporating Orgasmic Meditation (OM), a structured attention training practice involving 15 minutes of gentle clitoral stroking, was tested for safety and efficacy in 28 participants (14 pairs) in Massachusetts, 23 of whom had PTSD symptoms (PCL-5 scores >31). Participants performed OM at least 12 times and attended weekly safety check-ins. PTSD scores improved by 47%, with the average score dropping from 60 to 28. Participants rated OM's safety 4.9 out of 5. The practice appears safe for traumatized populations and may reduce PTSD symptoms, warranting further research.