Suvorexant 3 - PE-PC

Summary

The goal of this clinical trial is to learn if combining suvorexant (a sleep medication) with a shorter form of prolonged exposure therapy called PE-PC works to treat PTSD symptoms and improve sleep in Veterans and military personnel with PTSD and insomnia, with and without mild-to-moderate traumatic brain injury (TBI). The main questions it aims to answer are: Does suvorexant, when combined with PE-PC therapy, reduce PTSD symptoms more than PE-PC with a placebo (a look-alike substance that contains no drug)? Does suvorexant, when combined with PE-PC therapy, improve psychosocial and physical functioning more than PE-PC with a placebo? Researchers will compare PE-PC combined with suvorexant to PE-PC combined with a placebo to see if adding suvorexant improves PTSD symptoms, sleep, and overall functioning in Veterans. Participants will: Receive weekly PE-PC therapy sessions for 8 weeks Take suvorexant (10-20 mg) or a placebo each night during the 8-week treatment period. Complete repeated assessments of PTSD symptoms, sleep, and psychosocial and physical functioning throughout the study.

Timeline

Start

2026-09-01

Primary completion

2029-03-01

Completion

2029-08-30

Publications

• Background Herring WJ, Connor KM, Ivgy-May N, Snyder E, Liu K, Snavely DB, Krystal AD, Walsh JK, Benca RM, Rosenberg R, Sangal RB, Budd K, Hutzelmann J, Leibensperger H, Froman S, Lines C, Roth T, Michelson D. Suvorexant in Patients With Insomnia: Results From Two 3-Month Randomized Controlled Clinical Trials. Biol Psychiatry. 2016 Jan 15;79(2):136-48. doi: 10.1016/j.biopsych.2014.10.003. Epub 2014 Oct 23.
• Background Kobayashi I, Mellman TA, Cannon A, Brown I, Boadi L, Howell MK, Lavela P, Sandhu I. Blocking the orexin system following therapeutic exposure promoted between session habituation, but not PTSD symptom reduction. J Psychiatr Res. 2022 Jan;145:222-229. doi: 10.1016/j.jpsychires.2021.12.027. Epub 2021 Dec 14.
• Background Rauch SAM, Kim HM, Acierno R, Ragin C, Wangelin B, Blitch K, Muzzy W, Hart S, Zivin K. Improving function through primary care treatment of posttraumatic stress disorder study outcomes: A randomized controlled trial of prolonged exposure for primary care in veterans. Fam Syst Health. 2023 Dec;41(4):502-513. doi: 10.1037/fsh0000823. Epub 2023 Aug 31.
• Background Gilbert KS, Kark SM, Gehrman P, Bogdanova Y. Sleep disturbances, TBI and PTSD: Implications for treatment and recovery. Clin Psychol Rev. 2015 Aug;40:195-212. doi: 10.1016/j.cpr.2015.05.008. Epub 2015 Jun 3.
• Background Wisco BE, Nomamiukor FO, Marx BP, Krystal JH, Southwick SM, Pietrzak RH. Posttraumatic Stress Disorder in US Military Veterans: Results From the 2019-2020 National Health and Resilience in Veterans Study. J Clin Psychiatry. 2022 Feb 22;83(2):20m14029. doi: 10.4088/JCP.20m14029.
• Background Neylan TC, Marmar CR, Metzler TJ, Weiss DS, Zatzick DF, Delucchi KL, Wu RM, Schoenfeld FB. Sleep disturbances in the Vietnam generation: findings from a nationally representative sample of male Vietnam veterans. Am J Psychiatry. 1998 Jul;155(7):929-33. doi: 10.1176/ajp.155.7.929.

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Indications