Protocol Title: Kappa Opioid Receptor Antagonism for the Treatment of Alcohol Use Disorder (AUD) and Comorbid Post Traumatic Stress Disorder (PTSD)
Objective:
Evaluate the efficacy and physiological effects of buprenorphine combined with naltrexone in the treatment of comorbid AUD and PTSD.
Hypothesis:
Compared to the placebo group, a proportionally higher number of participants will respond to treatment with buprenorphine and naltrexone, with the primary efficacy endpoint being a reduction of both AUD and PTSD symptoms.
Primary Inclusion Criteria:
Treatment-seeking veterans, non-veterans, and active duty service members with both PTSD and AUD.
Subject Completion Target: n = 90 subjects
Study Synopsis:
This Phase II Randomized Controlled Trial (RCT), has a 24-month enrollment period, with a participant duration of 14 weeks (from the time of randomization).
The study visits are on weeks 1, 2, 4, 6, 8, 10, and 12. Primary and secondary efficacy endpoints are at week 8. At week 8, participants remain on the assigned drug or placebo for an additional 4 weeks to allow for a 12-week endpoint. Study medication is discontinued at week 12 and participants return at week 14 for evaluation of withdrawal side effects.