AS170014-A6 Lofexidine Study

Protocol Title: Lofexidine Combined with Buprenorphine for Reducing Symptoms of Post-Traumatic Stress Disorder and Opioid Use Relapse in Veterans

Objective: The primary objective is to determine if, as an adjunct to buprenorphine, treatment with lofexidine, an alpha-2-adrenergic receptor agonist, improves symptoms of both opioid use disorder (OUD) and Post-Traumatic Stress Disorder (PTSD). Other study objectives are to compare the safety, tolerability, and efficacy of BUP treatment alone, to BUP treatment with adjunct LFX, on measures of OUD and PTSD in Veterans with both disorders.

Primary Inclusion Criteria: Demonstrate willingness and ability to provide informed consent for study participation. Be a Veteran. Have or meet DSM criteria for PTSD and OUD. Be currently receiving buprenorphine as a treatment for OUD.  **

Subject Completion Target: n = 120

Study Protocol: This is a 12-week, phase II, randomized, double-blind, placebo controlled, single-site, parallel groups study to determine the potential efficacy of lofexidine for reducing opioid use relapse and symptoms of PTSD in veterans.