MedTrace Logo

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

NCT04360681 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-05-08

No results posted yet for this study

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 .

Conditions

  • Post Traumatic Stress Disorder
  • Opioid-use Disorder

Interventions

DRUG

Lofexidine

BID dosing, and a max daily dose of 1.6 mg/day

DRUG

Placebo oral tablet

Placebo

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • RTI International

    collaborator OTHER

  • Michael E. DeBakey VA Medical Center

    collaborator FED

  • USWM, LLC (dba US WorldMeds)

    collaborator INDUSTRY

  • Foundation for Advancing Veterans' Health Research

    collaborator OTHER

  • Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

    lead OTHER

Principal Investigators

  • Christopher D. Verrico, PhD · Baylor College of Medicine

  • Thomas R Kosten, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-09
Primary Completion
2025-12-15
Completion
2026-01-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04360681 on ClinicalTrials.gov