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Showing 1–17 of 17 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: LUCEMYRA (lofexidine) tablets Clear all
Completed Phase 3 Interventional Results available

Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal

NCT01863186
View directory record Official record
Conditions
Opioid Dependence, Acute Opioid Withdrawal Syndrome
Interventions
Lofexidine HCl, Placebo, Open Label Lofexidine HCL
Drug
Lead sponsor
USWM, LLC (dba US WorldMeds)
Industry
Eligibility
18 Years and older
Enrollment
603 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
18
States / cities
Clovis, California • Escondido, California • San Diego, California + 15 more
Source: ClinicalTrials.gov public record
Updated Mar 21, 2022 · Synced Sep 27, 2026, 5:28 PM EDT
Terminated Phase 2 Interventional Results available

Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal

NCT04070157
View directory record Official record
Conditions
Opioid Withdrawal (Disorder)
Interventions
Lofexidine, Placebo
Drug
Lead sponsor
USWM, LLC (dba US WorldMeds)
Industry
Eligibility
18 Years and older
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019
U.S. locations
12
States / cities
Placentia, California • Rancho Mirage, California • Plantation, Florida + 9 more
Source: ClinicalTrials.gov public record
Updated Oct 20, 2024 · Synced Sep 27, 2026, 5:28 PM EDT
Recruiting Phase 2 Interventional Accepts healthy volunteers

Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal

NCT05995535
View directory record Official record
Conditions
Opiate Withdrawal Syndrome, Opioid Use
Interventions
LFX/PGB, LFX/PLA-PGB
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years and older
Enrollment
150 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2026
U.S. locations
2
States / cities
Baltimore, Maryland • Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Feb 12, 2026 · Synced Sep 27, 2026, 5:28 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

A Study Evaluating the Relative Bioavailability of Lofexidine Granules for Reconstitution Compared to LUCEMYRA (Lofexidine) Tablets and the Effect of Food on the Bioavailability of the Lofexidine Granules for Reconstitution

NCT04188730
View directory record Official record
Conditions
Normal Healthy Volunteers
Interventions
Lofexidine (granules for reconstitution), LUCEMYRA (lofexidine) tablets
Drug
Lead sponsor
USWM, LLC (dba US WorldMeds)
Industry
Eligibility
18 Years to 50 Years
Enrollment
16 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021
U.S. locations
1
States / cities
Las Vegas, Nevada
Source: ClinicalTrials.gov public record
Updated Jun 14, 2022 · Synced Sep 27, 2026, 5:28 PM EDT
Completed Phase 3 Interventional Results available

Open-Label, Safety Study of Lofexidine

NCT02363998
View directory record Official record
Conditions
Opioid Withdrawal
Interventions
Lofexidine
Drug
Lead sponsor
USWM, LLC (dba US WorldMeds)
Industry
Eligibility
18 Years and older
Enrollment
286 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015
U.S. locations
18
States / cities
Little Rock, Arkansas • Springdale, Arkansas • San Diego, California + 15 more
Source: ClinicalTrials.gov public record
Updated Mar 21, 2022 · Synced Sep 27, 2026, 5:28 PM EDT
Completed Phase 1 Interventional

Pharmacokinetic & Pharmacodynamic Interaction of Lofexidine and Buprenorphine in Buprenorphine Maintained Patients

NCT01820442
View directory record Official record
Conditions
Opioid Dependence, Buprenorphine Withdrawal Syndrome
Interventions
Lofexidine HCl, Lofexidine-matching sugar pill
Drug
Lead sponsor
USWM, LLC (dba US WorldMeds)
Industry
Eligibility
18 Years to 60 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Feb 22, 2018 · Synced Sep 27, 2026, 5:28 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Single-Dose Pharmacokinetics and Safety of Oral Lofexidine in Hepatically-Impaired Subjects

NCT02318836
View directory record Official record
Conditions
Liver Failure
Interventions
Lofexidine Hydrochloride (HCl) tablets
Drug
Lead sponsor
USWM, LLC (dba US WorldMeds)
Industry
Eligibility
18 Years to 65 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Feb 22, 2018 · Synced Sep 27, 2026, 5:28 PM EDT
Withdrawn Phase 1 Interventional

A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects

NCT06711640
View directory record Official record
Conditions
Opioid Withdrawal (Disorder), Opioid Use Disorder
Interventions
LUCEMYRA (lofexidine) tablets
Drug
Lead sponsor
USWM, LLC (dba US WorldMeds)
Industry
Eligibility
12 Years to 18 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Jul 31, 2025 · Synced Sep 27, 2026, 5:28 PM EDT
Completed Phase 2 Interventional Results available

Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment

NCT04056182
View directory record Official record
Conditions
Opioid-use Disorder
Interventions
Lofexidine 0.18 MG
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 60 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Dec 8, 2021 · Synced Sep 27, 2026, 5:28 PM EDT
Completed Phase 4 Interventional Results available

Lofexidine for Adults Undergoing Lumbar Spine Surgery

NCT04126083
View directory record Official record
Conditions
Opioid Withdrawal
Interventions
Lofexidine Oral Tablet
Drug
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years to 70 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Feb 22, 2022 · Synced Sep 27, 2026, 5:28 PM EDT
Completed Phase 2 Interventional Results available

Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal

NCT04218240
View directory record Official record
Conditions
Opioid Withdrawal
Interventions
Pregabalin 200 MG capsules, Placebo oral tablet, Lofexidine 0.18Mg Tab
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years to 70 Years
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
3
States / cities
Baltimore, Maryland • New York, New York • Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Sep 18, 2024 · Synced Sep 27, 2026, 5:28 PM EDT
Completed Not applicable Interventional

Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder

NCT05053503
View directory record Official record
Conditions
Opioid-use Disorder, Opioid Withdrawal
Interventions
Sparrow Ascent Therapy System, Lofexidine, Extended-release injectable naltrexone
Device · Drug
Lead sponsor
Spark Biomedical, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
108 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
4
States / cities
Rancho Mirage, California • Crownsville, Maryland • Center City, Minnesota + 1 more
Source: ClinicalTrials.gov public record
Updated Jul 3, 2025 · Synced Sep 27, 2026, 5:28 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Assessment of the Effect of Naltrexone on Lofexidine Single Dose Pharmacokinetics in Healthy Subjects

NCT02446002
View directory record Official record
Conditions
Healthy
Interventions
Lofexidine + Naltrexone
Drug
Lead sponsor
USWM, LLC (dba US WorldMeds)
Industry
Eligibility
18 Years to 60 Years
Enrollment
25 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Oct 25, 2017 · Synced Sep 27, 2026, 5:28 PM EDT
Completed Phase 1 Interventional

Main Study of Lofexidine and Methadone Pharmacodynamic Interaction in Methadone Maintained Patients

NCT01650649
View directory record Official record
Conditions
Opioid Dependence, Methadone Withdrawal Syndrome
Interventions
Lofexidine HCl, Lofexidine-matching sugar pill
Drug
Lead sponsor
USWM, LLC (dba US WorldMeds)
Industry
Eligibility
18 Years to 60 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Oct 25, 2017 · Synced Sep 27, 2026, 5:28 PM EDT
Completed Phase 1 Interventional

Pilot Study of Lofexidine and Methadone Pharmacodynamic Interaction in Methadone Maintained Patients

NCT01558934
View directory record Official record
Conditions
Opioid Dependence, Methadone Withdrawal Syndrome
Interventions
Lofexidine HCl
Drug
Lead sponsor
USWM, LLC (dba US WorldMeds)
Industry
Eligibility
18 Years to 60 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Feb 22, 2018 · Synced Sep 27, 2026, 5:28 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Lofexidine Food Effect Study in Healthy Volunteers

NCT01437306
View directory record Official record
Conditions
Healthy
Interventions
Lofexidine HCl
Drug
Lead sponsor
USWM, LLC (dba US WorldMeds)
Industry
Eligibility
18 Years to 50 Years
Enrollment
13 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Feb 22, 2018 · Synced Sep 27, 2026, 5:28 PM EDT
Completed Phase 2 Interventional

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

NCT04360681
View directory record Official record
Conditions
Post Traumatic Stress Disorder, Opioid-use Disorder
Interventions
Lofexidine, Placebo oral tablet
Drug
Lead sponsor
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
Other
Eligibility
18 Years to 70 Years
Enrollment
84 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
2
States / cities
Houston, Texas • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated May 7, 2026 · Synced Sep 27, 2026, 5:28 PM EDT