Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 Opioid Use Disorder and Post Traumatic Stress 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 is a Phase 2 study of Opioid Use Disorder and Post Traumatic Stress 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 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04360681, a Phase 2 study of Opioid Use Disorder and Post Traumatic Stress 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 .

Conditions Studied

Opioid Use Disorder Post Traumatic Stress Disorder

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

FieldValue
Enrollment Target 120 participants
Start Date 2021-03-09
Est. Completion 2025-12-31
Phase Phase 2

Sponsor

Pharmacotherapies for Alcohol and Substance Use Disorders Alliance

5 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04360681

The ClinicalTrials.gov registry entry for NCT04360681 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (97% lower). The listed sponsor is Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral tablet is the first listed.

NCT04360681 reports 2 study locations spanning 1 distinct geographic area - top geographies include 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: Opioid Use Disorder, Post Traumatic Stress 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 Opioid Use 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.

Explore more on PlainTrial

Opioid Use Disorder

All registered trials for this condition

Post Traumatic Stress Disorder

All registered trials for this condition

Texas

All trials with a study site in Texas

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.