RecruitingPhase 2NCT04360681

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


Sponsor

Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

Enrollment

120 participants

Start Date

Mar 9, 2021

Study Type

INTERVENTIONAL

Conditions

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 .


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called lofexidine to buprenorphine (a medication used to treat opioid use disorder) can help veterans reduce symptoms of PTSD and lower the risk of relapse. Lofexidine is an FDA-approved medication that calms the nervous system and may help with both opioid cravings and PTSD anxiety. **You may be eligible if:** - You are 18 to 70 years old - You can read and understand English - You are currently on a stable dose of buprenorphine (for opioid use disorder) for at least 7 days - You have not been imprisoned, are not a minor, and do not have dementia or a terminal illness **You may NOT be eligible if:** - You are not currently on a stable buprenorphine dose (you may be referred to a program to get stabilized first) - You have conditions that make lofexidine unsafe for you (your doctor will assess this) - You are unable to give informed consent independently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLofexidine

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

DRUGPlacebo oral tablet

Placebo


Locations(2)

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, United States

South Texas Veterans Health Care System

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04360681


Related Trials