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Showing 1–24 of 38 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Lofexidine HCl Clear all
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 5, 2026, 11:24 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 25, 2017 · Synced Sep 5, 2026, 11:24 AM EDT
Completed Phase 2Phase 3 Interventional Accepts healthy volunteers Results available

An Innovative Intervention for OUD Treatment

NCT04325659
View directory record Official record
Conditions
Opioid-Related Disorders, Opioid Dependence, Opioid Addiction, Opioid Withdrawal
Interventions
Bridge Device, Lofexidine, Placebo, Sham Bridge Device
Device · Drug
Lead sponsor
Johns Hopkins University
Other
Eligibility
18 Years to 65 Years
Enrollment
36 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2025
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Jun 8, 2026 · Synced Sep 5, 2026, 11:24 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 21, 2022 · Synced Sep 5, 2026, 11:24 AM 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 5, 2026, 11:24 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 11, 2017 · Synced Sep 5, 2026, 11:24 AM EDT
Completed Phase 1 Interventional

Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 3

NCT00000354
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
Timeline
1996 – 1997
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jan 11, 2017 · Synced Sep 5, 2026, 11:24 AM EDT
Completed Phase 1 Interventional

Evaluation of Lofexidine for Treatment of Opiate Withdrawal - 10

NCT00000345
View directory record Official record
Conditions
Opioid-Related Disorders
Interventions
Lofexidine
Drug
Lead sponsor
National Institute on Drug Abuse (NIDA)
NIH
Eligibility
21 Years to 50 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 1996
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Jan 11, 2017 · Synced Sep 5, 2026, 11:24 AM 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 5, 2026, 11:24 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 19, 2009 · Synced Sep 5, 2026, 11:24 AM EDT
Completed Phase 2 Interventional Results available

Effectiveness of Lofexidine to Prevent Stress-Related Opiate Relapse During Naltrexone Treatment - 1

NCT00142909
View directory record Official record
Conditions
Opioid-Related Disorders
Interventions
Lofexidine, Placebo
Drug
Lead sponsor
Yale University
Other
Eligibility
18 Years and older
Enrollment
86 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2009
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Jul 29, 2015 · Synced Sep 5, 2026, 11:24 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 3, 2025 · Synced Sep 5, 2026, 11:24 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Combined Pharmacotherapy for Cannabis Dependency

NCT01020019
View directory record Official record
Conditions
Cannabis Dependence, Marijuana Dependence
Interventions
Dronabinol, Placebo, Lofexidine
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 60 Years
Enrollment
156 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2014
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Apr 23, 2019 · Synced Sep 5, 2026, 11:24 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 11, 2017 · Synced Sep 5, 2026, 11:24 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 6, 2025 · Synced Sep 5, 2026, 11:24 AM 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 5, 2026, 11:24 AM EDT
Completed Phase 1 Interventional

Effectiveness of Naltrexone and Lofexidine in Treating Detoxified Heroin Addicts - 1

NCT00218530
View directory record Official record
Conditions
Heroin Dependence
Interventions
Lofexidine
Drug
Lead sponsor
National Institute on Drug Abuse (NIDA)
NIH
Eligibility
18 Years to 100 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2004
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Jan 11, 2017 · Synced Sep 5, 2026, 11:24 AM 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 5, 2026, 11:24 AM 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 5, 2026, 11:24 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 22, 2018 · Synced Sep 5, 2026, 11:24 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 14, 2022 · Synced Sep 5, 2026, 11:24 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 23, 2026 · Synced Sep 5, 2026, 11:24 AM EDT
Active, not recruiting Phase 2 Interventional

Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids

NCT06047834
View directory record Official record
Conditions
Opioid Withdrawal (Disorder)
Interventions
Standard of Care with Lofexidine, Standard of Care without Lofexidine
Drug · Other
Lead sponsor
BioCorRx Pharmaceuticals Inc
Other
Eligibility
0 Hours to 6 Days
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
1
States / cities
Huntington, West Virginia
Source: ClinicalTrials.gov public record
Updated Sep 30, 2025 · Synced Sep 5, 2026, 11:24 AM EDT
Recruiting Phase 2 Interventional

Assessing a Clinically-meaningful Opioid Withdrawal Phenotype

NCT05027919
View directory record Official record
Conditions
Opioid Withdrawal, Opioid Use Disorder, Opioid Craving
Interventions
Hydromorphone, Naloxone + lofexidine pretreatment, Naloxone + placebo pretreatment, Lofexidine
Drug
Lead sponsor
University of Maryland, Baltimore
Other
Eligibility
18 Years to 65 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Sep 11, 2025 · Synced Sep 5, 2026, 11:24 AM EDT