drugset / Trial / NCT04360681
Lofexidine Combined With Buprenorphine for Reducing Symptoms of PTSD and OU Relapse in Veterans
Phase 2
Completed
84 enrolled
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Foundation for Advancing Veterans' Health Research · collabMichael E. DeBakey VA Medical Center · collabRTI International · collabUSWM, LLC (dba US WorldMeds) · collabUnited States Department of Defense · collab
RandomizedParallel-groupQuadruple-blindTreatment
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 .
Timeline
- Start
- 2021-03-09
- Primary completion
- 2025-12-15
- Completion
- 2026-01-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lofexidine | Small molecule | 1.2 mg | Oral |
| Subject | Lofexidine | Small molecule | 1.6 mg | Oral |