7 completed, 3 recruiting, 1 active not recruiting, 1 not yet recruiting. 14 Phase 2, 6 Phase 1, 2 Phase 3.
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal Dexmedetomidine, Placebo - Opioid Withdrawal | Phase 1 / Phase 2 | Completed | BioXcel Therapeutics Inc | 225 | 2020-06-09 | 2026-08-11 |
| Medical Management of Sleep Disturbance During Opioid Tapering Placebo oral capsule, Low Dose Suvorexant, High Dose Suvorexant - Opioid Dependence, Opioid Withdrawal | Phase 2 | Completed | Johns Hopkins University | 90 | 2019-07-01 | 2022-08-08 |
| Oxytocin Treatment of Opioid Dependence Intranasal Oxytocin Spray, Placebo - Opioid Dependence, Opioid Withdrawal | Phase 1 / Phase 2 | Completed | University of North Carolina, Chapel Hill | 12 | 2016-02-01 | 2019-08-07 |
| Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals Buprenorphine - Opioid Dependence, Opioid Withdrawal | Phase 2 | Completed | University of Arkansas | 30 | 2010-10-01 | 2013-06-21 |
Opioid-Related Disorders (12) · Substance-Related Disorders (2) · Anxiety Disorders (1) · Behavior, Addictive (1) · Chronic Pain (1) · Marijuana Abuse (1) · Mental Disorders (1) · Morphine Dependence (1) · Parasomnias (1) · Psychomotor Agitation (1) · Recurrence (1) · Restless Legs Syndrome (1) · Sleep Wake Disorders (1)
Chemically-Induced Disorders (12) · Narcotic-Related Disorders (12) · Mental Disorders (11) · Substance-Related Disorders (10) · Pathological Conditions, Signs and Symptoms (4) · Nervous System Diseases (3) · Neurologic Manifestations (3) · Signs and Symptoms (3) · Behavior (2) · Aberrant Motor Behavior in Dementia (1) · Behavioral Symptoms (1) · Compulsive Behavior (1) · Disease Attributes (1) · Dyskinesias (1) · Dyssomnias (1)
lofexidine (5) · Buprenorphine (1) · Buprenorphine, Naloxone Drug Combination (1) · Buspirone (1) · Cannabidiol (1) · Dexmedetomidine (1) · Gabapentin (1) · Hydromorphone (1) · Naloxone (1) · Pramipexole (1) · Pregabalin (1) · Transcranial Magnetic Stimulation (1) · suvorexant (1)
Johns Hopkins University (3) · University of Maryland, Baltimore (2) · Aphios (1) · BioXcel Therapeutics Inc (1) · Clive Michelsen (1) · Massachusetts General Hospital (1) · Medical University of South Carolina (1) · New York State Psychiatric Institute (1) · University of Arkansas (1) · University of North Carolina, Chapel Hill (1) · University of Pennsylvania (1)
United States (13)
Alison Oliveto, Ph.D. (1) · Andrew S Huhn, PhD (1) · BioXcel MM, MD (1) · Cecilia Bergeria, Ph.D. (1) · Cecilia L Bergeria, PhD (1) · Cort A Pedersen, MD (1) · Eric Strain (1) · James C Garbutt, MD (1) · John W Winkelman, MD/PhD (1) · Kelly Barth (1) · Kelly E Dunn, Ph.D, M.B.A. (1) · Sandra Comer, Ph.D (1) · Stuart Watson (1)
R01DA010017 (1), R01DA048761 (1), R01DA052937 (1), R01DA058620 (1), R21DA052861 (1), UG3DA048734 (1), UG3DA056247-01 (1)