31 completed, 3 recruiting, 2 active not recruiting, 2 terminated. 18 Phase 1, 14 Phase 2, 6 Phase 3, 3 Phase 4, 1 Not applicable.
Follow lofexidine: new trials by email Literature Review of lofexidine trials Research Report on lofexidine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects LUCEMYRA (lofexidine) tablets - Opioid Withdrawal (Disorder), Opioid Use Disorder | Phase 1 | Withdrawn | USWM, LLC (dba US WorldMeds) | 2025-06-01 | 2025-08-01 | |
| Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal LFX/PGB, LFX/PLA-PGB - Opiate Withdrawal Syndrome, Opioid Use | Phase 2 | Recruiting | University of Pennsylvania | 150 | 2024-01-01 | 2026-02-13 |
| Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids Standard of Care with Lofexidine, Standard of Care without Lofexidine - Opioid Withdrawal (Disorder) | Phase 2 | Active not recruiting | BioCorRx Pharmaceuticals Inc | 24 | 2023-10-02 | 2025-10-01 |
| Sublingual Dexmedetomidine for Treating Opioid Withdrawal BXCL501 (180 micrograms), BXCL501 (240 micrograms), Placebo - Opioid Use Disorder, Opioid Withdrawal | Phase 1 / Phase 2 | Active not recruiting | New York State Psychiatric Institute | 160 | 2023-02-28 | 2026-10-28 |
| Evaluating Buspirone to Treat Opioid Withdrawal Buspirone, Lofexidine, Placebo - Opioid Use Disorder, Opioid Withdrawal | Phase 2 | Recruiting | University of Maryland, Baltimore | 100 | 2022-12-15 | 2026-08-24 |
| Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder Sparrow Ascent Therapy System, Lofexidine, Extended-release injectable naltrexone - Opioid-use Disorder, Opioid Withdrawal | Not applicable | Completed | Spark Biomedical, Inc. | 108 | 2022-05-27 | 2025-07-04 |
| Assessing a Clinically-meaningful Opioid Withdrawal Phenotype Hydromorphone, Naloxone + lofexidine pretreatment, Naloxone + placebo pretreatment - Opioid Withdrawal, Opioid Use Disorder | Phase 2 | Recruiting | University of Maryland, Baltimore | 60 | 2021-12-01 | 2025-09-12 |
| Lofexidine Combined With Buprenorphine for Reducing Symptoms of PTSD and OU Relapse in Veterans Lofexidine, Placebo oral tablet - Post Traumatic Stress Disorder, Opioid-use Disorder | Phase 2 | Completed | Pharmacotherapies for Alcohol and Substance Use Disorders Alliance | 84 | 2021-03-09 | 2026-05-08 |
| 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 Lofexidine (granules for reconstitution), LUCEMYRA (lofexidine) tablets - Normal Healthy Volunteers | Phase 1 | Completed | USWM, LLC (dba US WorldMeds) | 16 | 2021-02-16 | 2022-06-15 |
| Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal Pregabalin 200 MG capsules, Placebo oral tablet, Lofexidine 0.18Mg Tab - Opioid Withdrawal | Phase 2 | Completed | University of Pennsylvania | 90 | 2020-12-17 | 2024-09-19 |
| An Innovative Intervention for OUD Treatment Bridge Device, Lofexidine, Placebo - Opioid-Related Disorders, Opioid Dependence | Phase 2 / Phase 3 | Completed | Johns Hopkins University | 36 | 2020-11-15 | 2026-06-09 |
| Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment Lofexidine 0.18 MG - Opioid-use Disorder | Phase 2 | Completed | New York State Psychiatric Institute | 20 | 2019-09-01 | 2021-12-09 |
| Lofexidine for Adults Undergoing Lumbar Spine Surgery Lofexidine Oral Tablet - Opioid Withdrawal | Phase 4 | Completed | Mayo Clinic | 6 | 2019-09-01 | 2022-02-23 |
| Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal Lofexidine, Placebo - Opioid Withdrawal (Disorder) | Phase 2 | Terminated | USWM, LLC (dba US WorldMeds) | 4 | 2019-08-02 | 2024-10-21 |
| Impact of Lofexidine on Stress, Craving and Opioid Use Lofexidine, Placebo - Opioid-use Disorder, Opiate Dependence | Phase 2 | Completed | Medical University of South Carolina | 112 | 2019-06-26 | 2025-02-07 |
| Treatment of Withdrawal Symptoms and Prevention of Relapse in Patients With Tramadol Abuse Venlafaxine, Lofexidine - Opiate Withdrawal Syndrome | Phase 4 | Completed | Zagazig University | 52 | 2019-01-01 | 2022-10-06 |
| Lofexidine Pharmacokinetics in the Presence of Paroxetine in Healthy Volunteers Lofexidine, Paroxetine - Healthy | Phase 1 | Completed | USWM, LLC (dba US WorldMeds) | 24 | 2016-01-01 | 2018-02-23 |
| Assessment of the Effect of Naltrexone on Lofexidine Single Dose Pharmacokinetics in Healthy Subjects Lofexidine + Naltrexone - Healthy | Phase 1 | Completed | USWM, LLC (dba US WorldMeds) | 25 | 2015-05-01 | 2017-10-26 |
| Open-Label, Safety Study of Lofexidine Lofexidine - Opioid Withdrawal | Phase 3 | Completed | USWM, LLC (dba US WorldMeds) | 286 | 2015-02-01 | 2022-03-22 |
| Single-dose Pharmacokinetics and Safety of Oral Lofexidine in Renally-Impaired Subjects lofexidine HCl - Renally Impaired Subjects | Phase 1 | Completed | USWM, LLC (dba US WorldMeds) | 16 | 2014-11-01 | 2017-10-26 |
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Opioid-Related Disorders (19) · Marijuana Abuse (2) · Substance Withdrawal Syndrome (2) · Substance-Related Disorders (2) · Anxiety Disorders (1) · Cocaine-Related Disorders (1) · Heroin Dependence (1) · Kidney Failure, Chronic (1) · Liver Failure (1) · Stress Disorders, Post-Traumatic (1)
USWM, LLC (dba US WorldMeds) (15) · National Institute on Drug Abuse (NIDA) (6) · New York State Psychiatric Institute (4) · University of Maryland, Baltimore (2) · University of Pennsylvania (2) · BioCorRx Pharmaceuticals Inc (1) · Institute of Mental Health, Singapore (1) · Johns Hopkins University (1) · Mayo Clinic (1) · Medical University of South Carolina (1) · Pharmacotherapies for Alcohol and Substance Use Disorders Alliance (1) · Spark Biomedical, Inc. (1) · US Department of Veterans Affairs (1) · Yale University (1) · Zagazig University (1)
United States (37) · Egypt (1) · Singapore (1)
Charles W Gorodetzky, MD, PhD (7) · James A Longstreth, PhD (6) · Charles O'Brien, M.D., Ph.D. (2) · James Longstreth, PhD (2) · Mark Leibowitz, MD (2) · Thomas Marbury, MD (2) · Ann Montgomery, R.N. (1) · Cecilia Bergeria, Ph.D. (1) · Charles Gorodetzky, MD (1) · Charles Gorodetzky, MD, PhD (1) · Charles W. Gorodetzky (1) · Charles W. Gorodetzky, MD, PhD (1) · Christopher D. Verrico, PhD (1) · Eric Strain (1)
PMID 32002194, PMID 29457671, PMID 29910009, PMID 30531234, PMID 31606589, PMID 34737091, PMID 37729663
U01DA030916 (3), U01DA033276 (3), 1UG3DA061620 (1), P50DA009236 (1), R01DA019239 (1), R01DA047690 (1), R01DA048761 (1), R01DA052937 (1), U54DA016511 (1), UG3DA056247-01 (1)