Lofexidine Combined With Buprenorphine for Reducing Symptoms of PTSD and OU Relapse in Veterans

Last updated on July 2021

Recruitment

Recruitment Status: Recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Opioid Use Disorder
Post Traumatic Stress Disorder

Type

Interventional

Phase

Phase 2

Design

Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a Phase 2 randomized, double-blind, placebo-controlled, single-site, parallel groups, 12-week treatment studyMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: To minimize bias, all participants will be screened for assurance that they meet study eligibility criteria. A placebo drug will be employed as the comparison group to active study drug and the study will be conducted in a double-blinded fashion in that both the participants and the site investigators and staff interacting with participants and assessing study outcomes will be blinded to treatment assignment. The only individuals at the site with assess to treatment assignment information will be the research pharmacists.Primary Purpose: Treatment

Participation Requirements

Age: Between 18 years and 65 years
Gender: Both males and females

Description

The aim of this clinical trial is to evaluate the efficacy of Lucemyra™ (lofexidine; LFX), an alpha-2-adrenergic receptor (?2-AR) agonist, as a medication for the prevention of opiate relapse and the alleviation of post-traumatic stress disorder (PTSD) symptoms in opiate-dependent veterans. Primary Endpoints : For OUD: Drug-Taking Behavior (% abstinent from illicit opioid use from Week 5 to Week 12 of the active treatment phase) is the primary efficacy endpoint for monitoring the effects of treatment on OUD, which is measured by both urine drug screen (UDS; opioids are detectable for 1-4 days) and timeline follow-back (TLFB) interviews of drug/alcohol use. For PTSD: The primary efficacy endpoint for monitoring the effects of treatment on PTSD symptoms is mean change scores on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5), which is recommended by the Department of Veterans Affairs and the Department of Defense (VA/DoD) Clinical Practice Guideline as a quantitative measure of a patient's PTSD symptoms and response to treatment over time. Secondary Endpoints: For OUD: Drug-Taking Behavior (? 80% abstinent between Week 5 to Week 12), treatment duration (days in treatment), and scores on the Subjective Opiate Withdrawal Scale (SOWS), the Clinical Opiate Withdrawal Scale (COWS), and the Opioid Craving Visual Analog Scale (OC-VAS) are secondary efficacy endpoints for monitoring the effects of treatment on symptoms on OUD. For PTSD: The secondary efficacy endpoints for monitoring the effects of treatment on core symptoms of PTSD are CAPS-5 change score (between screening and Week 12). Population: 120 veteran participants will be recruited from within the MEDVAMC. The study population will consist of veterans diagnosed with OUD and potential or provisional PTSD who are seeking treatment. Phase: This is a Phase 2 randomized, double-blind, placebo-controlled, single-site, parallel groups, 12-week treatment study Duration: Enrollment period of 24 months. Participant duration is 18 weeks (consisting of 4 weeks screening, a 12-week treatment period, and a 2-week follow-up).

Tracking Information

NCT #

NCT04360681

Collaborators

United States Department of Defense
RTI International
Michael Debakey Veterans Affairs Medical Center
US WorldMeds LLC

Investigators

Principal Investigator: Christopher D. Verrico, PhD Baylor College of Medicine Principal Investigator: Thomas R Kosten, MD Baylor College of Medicine