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ClinicalTrials.gov public records Last synced Oct 21, 2026, 5:59 AM EDT

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Showing 1–24 of 38 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Lofexidine HCl Clear all
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 9, 2021 · Synced Oct 21, 2026, 5:59 AM 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 23, 2018 · Synced Oct 21, 2026, 5:59 AM 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 26, 2017 · Synced Oct 21, 2026, 5:59 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Lofexidine Mass Balance in Volunteers

NCT01629446
View directory record Official record
Conditions
Normal Healthy Volunteers
Interventions
Lofexidine hydrochloride
Drug
Lead sponsor
USWM, LLC (dba US WorldMeds)
Industry
Eligibility
18 Years to 50 Years · Male only
Enrollment
6 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Oct 26, 2017 · Synced Oct 21, 2026, 5:59 AM EDT
Recruiting Phase 2 Interventional

Evaluating Buspirone to Treat Opioid Withdrawal

NCT05511909
View directory record Official record
Conditions
Opioid Use Disorder, Opioid Withdrawal, Opioid Craving, Anxiety
Interventions
Buspirone, Lofexidine, Placebo
Drug
Lead sponsor
University of Maryland, Baltimore
Other
Eligibility
18 Years to 75 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Aug 24, 2026 · Synced Oct 21, 2026, 5:59 AM 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 8, 2026 · Synced Oct 21, 2026, 5:59 AM EDT
Completed Phase 1 Interventional

Study to Evaluate the Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction

NCT02801357
View directory record Official record
Conditions
Substance Withdrawal Syndrome, Opiate Addiction, Opiate Dependence
Interventions
lofexidine administration in subjects seeking buprenorphine dose reduction
Drug
Lead sponsor
USWM, LLC (dba US WorldMeds)
Industry
Eligibility
18 Years to 64 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Oct 26, 2017 · Synced Oct 21, 2026, 5:59 AM 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 15, 2022 · Synced Oct 21, 2026, 5:59 AM EDT
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 22, 2022 · Synced Oct 21, 2026, 5:59 AM EDT
Terminated Phase 1 Interventional

Interactions Between Intravenous (IV) Cocaine and Lofexidine

NCT01148992
View directory record Official record
Conditions
Cocaine Related Disorders
Interventions
Lofexidine, Placebo
Drug
Lead sponsor
National Institute on Drug Abuse (NIDA)
NIH
Eligibility
18 Years to 50 Years
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
2
States / cities
San Francisco, California • Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jan 11, 2017 · Synced Oct 21, 2026, 5:59 AM EDT
Completed Phase 3 Interventional

Lofexidine for Opiate Withdrawal - 1

NCT00032942
View directory record Official record
Conditions
Opioid-Related Disorders
Interventions
Lofexidine
Drug
Lead sponsor
National Institute on Drug Abuse (NIDA)
NIH
Eligibility
18 Years to 99 Years
Enrollment
66 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2001
U.S. locations
3
States / cities
Los Angeles, California • New York, New York • Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jan 12, 2017 · Synced Oct 21, 2026, 5:59 AM 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 4, 2025 · Synced Oct 21, 2026, 5:59 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers

Effect of Lofexidine and Oral THC on Marijuana Withdrawal and Relapse

NCT00373503
View directory record Official record
Conditions
Marijuana Dependence
Interventions
Lofexidine, dronabinol, Marijuana
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
21 Years to 45 Years
Enrollment
8 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2005 – 2008
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Feb 5, 2013 · Synced Oct 21, 2026, 5:59 AM EDT
Active, not recruiting Phase 1Phase 2 Interventional

Sublingual Dexmedetomidine for Treating Opioid Withdrawal

NCT05712707
View directory record Official record
Conditions
Opioid Use Disorder, Opioid Withdrawal
Interventions
BXCL501 (180 micrograms), BXCL501 (240 micrograms), Placebo, Lofexidine (Positive Control)
Drug · Other
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 60 Years
Enrollment
160 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
4
States / cities
New Haven, Connecticut • Eatontown, New Jersey • Marlton, New Jersey + 1 more
Source: ClinicalTrials.gov public record
Updated Apr 14, 2026 · Synced Oct 21, 2026, 5:59 AM 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 22, 2022 · Synced Oct 21, 2026, 5:59 AM 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 21, 2024 · Synced Oct 21, 2026, 5:59 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Single-dose Pharmacokinetics and Safety of Oral Lofexidine in Renally-Impaired Subjects

NCT02313103
View directory record Official record
Conditions
Renally Impaired Subjects
Interventions
lofexidine HCl
Drug
Lead sponsor
USWM, LLC (dba US WorldMeds)
Industry
Eligibility
18 Years to 75 Years
Enrollment
16 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014 – 2015
U.S. locations
1
States / cities
Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Oct 26, 2017 · Synced Oct 21, 2026, 5:59 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Lofexidine ADME & Mass Balance in Volunteers

NCT01310296
View directory record Official record
Conditions
Normal Healthy Volunteers Will be Treated With Lofexidine to Understand the Absolute Bioavailability and Mass Balance Recovery of the Product
Interventions
Lofexidine hydrochloride
Drug
Lead sponsor
USWM, LLC (dba US WorldMeds)
Industry
Eligibility
18 Years to 50 Years
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Oct 26, 2017 · Synced Oct 21, 2026, 5:59 AM EDT
Completed Phase 2 Interventional Results available

Impact of Lofexidine on Stress, Craving and Opioid Use

NCT03718065
View directory record Official record
Conditions
Opioid-use Disorder, Opiate Dependence
Interventions
Lofexidine, Placebo
Drug
Lead sponsor
Medical University of South Carolina
Other
Eligibility
18 Years to 60 Years
Enrollment
112 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
1
States / cities
Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated Feb 7, 2025 · Synced Oct 21, 2026, 5:59 AM 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 26, 2017 · Synced Oct 21, 2026, 5:59 AM 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 23, 2018 · Synced Oct 21, 2026, 5:59 AM EDT
Completed Phase 3 Interventional

Lofexidine for Inpatient Opiate Detox

NCT00235729
View directory record Official record
Conditions
Opiate Addiction
Interventions
Lofexidine, Placebo
Drug
Lead sponsor
US Department of Veterans Affairs
Federal
Eligibility
18 Years and older
Enrollment
264 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2007
U.S. locations
16
States / cities
Cerritos, California • Washington D.C., District of Columbia • Atlanta, Georgia + 13 more
Source: ClinicalTrials.gov public record
Updated Mar 20, 2009 · Synced Oct 21, 2026, 5:59 AM EDT
Completed Phase 1 Interventional

Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 7

NCT00000358
View directory record Official record
Conditions
Opioid-Related Disorders, Substance-Related Disorders
Interventions
Lofexidine
Drug
Lead sponsor
National Institute on Drug Abuse (NIDA)
NIH
Eligibility
21 Years to 59 Years
Healthy volunteers
Healthy volunteers not accepted
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jan 12, 2017 · Synced Oct 21, 2026, 5:59 AM 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 19, 2024 · Synced Oct 21, 2026, 5:59 AM EDT