NCT04360681

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

Lofexidine Combined With Buprenorphine for Reducing Symptoms of Post-Traumatic Stress Disorder (PTSD) and Opioid Use Relapse in Veterans

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Pharmacotherapies for Alcohol and Substance Use Disorders Alliance · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of the proposed study is to determine if lofexidine (LFX) as an adjunct to buprenorphine (BUP) treatment 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 symptoms in Veterans with both prognosis .

Detailed description

The aim of this clinical trial is to evaluate the efficacy of Lucemyra™ (lofexidine; LFX), an alpha-2-adrenergic receptor (α2-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).

Conditions

• Post Traumatic Stress Disorder
• Opioid-use Disorder

Interventions

Type	Name	Description
DRUG	Lofexidine	BID dosing, and a max daily dose of 1.6 mg/day
DRUG	Placebo oral tablet	Placebo

Timeline

• Start date: 2021-03-09
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2020-04-24
• Last updated: 2025-06-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study