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NCT04360681 · ClinicalTrials.gov registry record · Phase 2
Lofexidine Combined With Buprenorphine for Reducing Symptoms of PTSD and OU Relapse in Veterans
A Phase 2 study of Post Traumatic Stress Disorder and Opioid Use Disorder, sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 2
- Study locations
NCT04360681: Recruiting Phase 2 study of Post Traumatic Stress Disorder and Opioid Use Disorder, sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance.
NCT04360681 is a Phase 2 study of Post Traumatic Stress Disorder and Opioid Use Disorder that is actively recruiting participants, run by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance. The registered enrollment target is 120 participants, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04360681, a Phase 2 study of Post Traumatic Stress Disorder and Opioid Use Disorder, is actively recruiting participants, sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 2
- Study locations
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 .
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo oral tablet
- DRUG Lofexidine
Study Locations (2)
Texas
- Michael E. DeBakey Veterans Affairs Medical Center - Houston
- South Texas Veterans Health Care System - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2021-03-09 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What NCT04360681 shows while recruiting
NCT04360681 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT04360681 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04360681 about?
NCT04360681 is a clinical study titled "Lofexidine Combined With Buprenorphine for Reducing Symptoms of PTSD and OU Relapse in Veterans". 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 o...
What is the current status of trial NCT04360681?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2021-03-09. Estimated completion is 2025-12-31.
What conditions does trial NCT04360681 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Opioid Use Disorder.
What interventions are being tested in trial NCT04360681?
The interventions under investigation include: Placebo oral tablet (DRUG), Lofexidine (DRUG).
Who is sponsoring clinical trial NCT04360681?
This trial is sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04360681 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Post Traumatic Stress Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04360681's enrollment target sits among peer trials
120 96th of 262 higher than 158 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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