20 completed, 7 recruiting, 3 withdrawn, 2 not yet recruiting. 14 Phase 2, 13 Not applicable, 6 Phase 1, 4 Phase 3, 3 Phase 4.
Follow Opioid Withdrawal: new trials by email Literature Review of Opioid Withdrawal trials Research Report on Opioid Withdrawal
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 |
|---|---|---|---|---|---|---|
| Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder Ibogaine Hydrochloride, Extended-release naltrexone injection, 380 mg, Matching Oral Placebo - Opioid Use Disorder, Opioid Withdrawal | Phase 1 / Phase 2 | Not yet recruiting | Clive Michelsen | 60 | 2027-07-01 | 2026-10-13 |
| Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome Recorded Parent/Caregiver Voice Playback - Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure | Not applicable | Not yet recruiting | University of Manitoba | 20 | 2026-11-01 | 2026-10-08 |
| Sparrow Link Neuromodulation Device for Opioid Withdrawal Management in Hospitalized Adults With Opioid Use Disorder Sparrow Link (Active tAN), Sparrow Link (Sham tAN) - Opioid Withdrawal, Opioid Use Disorder (OUD) | Not applicable | Recruiting | Payel Roy | 50 | 2026-05-27 | 2026-06-01 |
| CEDRN: Opioid Registry Opioid Use Disorder, Opioid Abuse or Dependence | Recruiting | University of British Columbia | 7200 | 2025-07-24 | 2026-03-12 | |
| Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder EmbracePlus Smartwatch, Corti Sensor - Opioid Withdrawal, Opioid Use Disorder | Recruiting | Spark Biomedical, Inc. | 20 | 2025-02-19 | 2026-09-28 | |
| ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain Buprenorphine Patch, Placebo, Transcranial Magnetic Stimulation (TMS) - Opioid Withdrawal, Chronic Pain | Phase 1 / Phase 2 | Recruiting | Medical University of South Carolina | 240 | 2024-08-12 | 2025-11-05 |
| Suboxone Dispenser for OUD Addinex - Opioid Use Disorder, Opioid Withdrawal | Not applicable | Withdrawn | Addinex Technologies, Inc. | 2024-01-15 | 2025-05-28 | |
| Exploratory Dose Ranging Study Assessing APH-1501 for the Treatment of Opioid Addiction APH-1501, Placebo - Addiction, Opioid Dependence | Phase 2 | Unknown | Aphios | 32 | 2023-10-01 | 2021-07-27 |
| Understanding the Effects of Transcutaneous Auricular Neurostimulation for Treatment of Chronic Pain transcutaneous Auricular neurostimulation - Active, transcutaneous auricular neurostimulation - Sham - Opioid Withdrawal, Analgesia | Not applicable | Recruiting | The University of Texas Medical Branch, Galveston | 60 | 2023-05-24 | 2026-08-10 |
| 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 |
| Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing Buprenorphine/naloxone - Opioid Use Disorder, Opioid Withdrawal | Unknown | United Health Services Hospitals, Inc. | 20 | 2022-07-01 | 2023-05-26 | |
| 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 |
| Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD Pramipexole, Placebo - Sleep Disorder, Restless Legs Syndrome | Phase 2 / Phase 3 | Terminated | Massachusetts General Hospital | 75 | 2022-01-24 | 2025-09-22 |
| Surviving Opioid Overdose With Naloxone Education and Resuscitation Trial (SOONER) SOONER Video & Kit, Standard of Care - Opioid Use, Opioid-Related Disorders | Not applicable | Withdrawn | Unity Health Toronto | 2021-12-01 | 2022-10-03 | |
| 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 |
| Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal Sparrow Therapy System - Opioid-use Disorder, Opioid Withdrawal | Not applicable | Completed | Spark Biomedical, Inc. | 6 | 2021-03-18 | 2021-08-19 |
| 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 |
| Oral Cannabidiol for Opioid Withdrawal Epidiolex, Placebo - Opioid Withdrawal, Opioid Craving | Phase 1 / Phase 2 | Completed | Johns Hopkins University | 3 | 2020-11-01 | 2023-08-29 |
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Opioid-Related Disorders (26) · Substance Withdrawal Syndrome (4) · Chronic Pain (3) · Substance-Related Disorders (3) · Anxiety Disorders (2) · Behavior, Addictive (2) · Neonatal Abstinence Syndrome (2) · Pain (2) · Acute Pain (1) · Agnosia (1) · Depression (1) · Drug Overdose (1) · Emergencies (1) · Marijuana Abuse (1) · Mental Disorders (1)
Chemically-Induced Disorders (29) · Mental Disorders (28) · Narcotic-Related Disorders (26) · Substance-Related Disorders (26) · Pathological Conditions, Signs and Symptoms (10) · Neurologic Manifestations (8) · Signs and Symptoms (8) · Behavior (5) · Nervous System Diseases (5) · Pain (3) · Pathologic Processes (3) · Behavioral Symptoms (2) · Compulsive Behavior (2) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (2) · Disease Attributes (2)
lofexidine (8) · Buprenorphine (3) · Buprenorphine, Naloxone Drug Combination (3) · Clonidine (2) · Morphine (2) · Naloxone (2) · Pregabalin (2) · Benzodiazepines (1) · Buspirone (1) · Cannabidiol (1) · Dexmedetomidine (1) · Drug Tapering (1) · Gabapentin (1) · Hydromorphone (1) · Inactivation, Metabolic (1)
Spark Biomedical, Inc. (4) · Johns Hopkins University (3) · University of Maryland, Baltimore (2) · Aarhus University Hospital (1) · Addinex Technologies, Inc. (1) · Aphios (1) · BioXcel Therapeutics Inc (1) · BrightView LLC (1) · Clive Michelsen (1) · Lund University Hospital (1) · Massachusetts General Hospital (1) · Mayo Clinic (1) · Medical University of South Carolina (1) · New York State Psychiatric Institute (1) · Payel Roy (1)
United States (29) · Canada (3) · Denmark (1) · Russia (1) · Sweden (1)
Navid Khodaparast, PhD (3) · Aaron Orkin, MD (1) · Alison Oliveto, Ph.D. (1) · Andrew S Huhn, PhD (1) · Anita Srivastava, MD (1) · BioXcel MM, MD (1) · Carlos Tirado, MD (1) · Carol Strike, PhD (1) · Cecilia Bergeria, Ph.D. (1) · Cecilia L Bergeria, PhD (1) · Charles W Gorodetzky, MD, PhD (1) · Corinne M Hohl, MD, MPH (1) · Cort A Pedersen, MD (1) · Eric Strain (1) · Frederick G Moeller, MD (1)
PMID 28378337, PMID 28514235, PMID 29278818, PMID 29535067, PMID 31088887, PMID 32157678, PMID 34321058, PMID 34433772, PMID 35187754, PMID 35978394, PMID 37125831, PMID 41102821, PMID 42113179
1RM1NS128787-01 (1), R01DA010017 (1), R01DA029078 (1), R01DA047867 (1), R01DA048761 (1), R01DA052937 (1), R01DA058620 (1), R21DA052861 (1), R43DA059448 (1), U01DA033276 (1), UG3DA048734 (1), UG3DA056247-01 (1)