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

RECRUITING Phase 2

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

NCT04360681 · View on ClinicalTrials.gov ↗

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 .

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

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04360681 reports 2 study locations spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04360681?

The interventions under investigation include: Placebo oral tablet (DRUG), Lofexidine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04360681?

This trial is sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial