15 completed, 1 terminated. 16 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 16 | Completed 15, Terminated 1 |
| Phase 2 | 3 | Completed 3 |
Follow Opiate Dependence: new trials by email Literature Review of Opiate Dependence trials Research Report on Opiate Dependence
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 |
|---|---|---|---|---|---|---|
| Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone extended release naltrexone - Opiate Dependence | Phase 2 / Phase 3 | Completed | University of Pennsylvania | 146 | 2016-01-01 | 2021-01-28 |
| Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence Buprenorphine/naloxone sublingual tablets, Buprenorphine - Opioid-Related Disorders, Opiate Dependence | Phase 3 | Completed | Orexo AB | 313 | 2013-06-01 | 2017-05-10 |
| Opioid Relapse & HIV Risk: 48 Versus 24 Weeks of Injectable Extended Release Naltrexone injectable naltrexone, placebo comparator - Opiate Dependence, Human Immunodeficiency Virus | Phase 2 / Phase 3 | Completed | University of Pennsylvania | 77 | 2013-06-01 | 2020-11-06 |
| Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia Vivitrol, Naltrexone (oral), BDRC - Opiate Dependence | Phase 3 | Completed | Yale University | 320 | 2011-09-01 | 2018-01-11 |
| Behavioral Drug and HIV Risk Reduction Counseling With MMT in China Behavioral Drug and HIV Risk Reduction Counseling, Educational Counseling, Treatment as Usual - Opiate Dependence | Phase 3 | Completed | Yale University | 300 | 2010-12-01 | 2020-03-06 |
| Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail Extended-Release Naltrexone, Motivational Enhancement Counseling - Opiate Dependence | Phase 3 | Completed | NYU Langone Health | 48 | 2010-05-01 | 2016-04-07 |
| Linking Hospitalized Injection Drug Users to Buprenorphine Linkage - Opiate Dependence | Phase 3 | Completed | Butler Hospital | 147 | 2009-09-01 | 2015-11-11 |
| ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals Medisorb naltrexone 380 mg - Opiate Dependence | Phase 3 | Completed | Alkermes, Inc. | 38 | 2009-03-01 | 2018-12-11 |
| ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence VIVITROL® 380 mg, Placebo - Opiate Dependence | Phase 3 | Completed | Alkermes, Inc. | 250 | 2008-06-01 | 2017-02-10 |
| Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone depot naltrexone, Oral Naltrexone - Opiate Dependence, Heroin Dependence | Phase 3 | Completed | New York State Psychiatric Institute | 60 | 2007-09-01 | 2017-08-25 |
| Behavioral Drug and HIV Risk Reduction Counseling in Methadone Patients in China Behavioral Drug and HIV Risk Reduction Counseling (BDRC), Drug counseling - Opiate Dependence, HIV Infections | Phase 3 | Completed | Yale University | 45 | 2007-09-01 | 2020-03-30 |
| SSRI and Buprenorphine escitalopram, placebo - Opiate Dependence, Depression | Phase 3 | Completed | Butler Hospital | 147 | 2006-12-01 | 2012-04-03 |
| Prescription Opioid Addiction Treatment Study (POATS) Standard Medical Management (SMM) of Prescription Opiate Abuse, Enhanced Medical Management (EMM) of Prescription Opiate Abuse - Opiate Dependence, Substance-related Disorders | Phase 3 | Completed | Mclean Hospital | 653 | 2006-05-01 | 2013-02-06 |
| HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a MMT Group. Ribavirin, Pegylated Interferon - Opiate Dependence, Hepatitis | Phase 3 | Completed | Sorlandet Hospital HF | 10 | 2006-03-01 | 2008-03-28 |
| Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction Go Medical Naltrexone implants - Opiate Dependence | Phase 2 / Phase 3 | Completed | University of Oslo | 56 | 2006-01-01 | 2009-05-05 |
| ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997]) Medisorb naltrexone 380 mg, Oral naltrexone to Medisorb naltrexone 380 mg - Alcoholism, Opiate Dependence | Phase 3 | Terminated | Alkermes, Inc. | 108 | 2004-08-01 | 2010-11-17 |
Opioid-Related Disorders (16) · Heroin Dependence (2) · Substance-Related Disorders (2) · Acquired Immunodeficiency Syndrome (1) · Alcoholism (1) · Behavior, Addictive (1) · Depression (1) · HIV Infections (1) · Hepatitis (1)
Chemically-Induced Disorders (16) · Mental Disorders (16) · Narcotic-Related Disorders (16) · Substance-Related Disorders (14) · Behavior (2) · Blood-Borne Infections (2) · Communicable Diseases (2) · Genital Diseases (2) · Immune System Diseases (2) · Immunologic Deficiency Syndromes (2) · Infections (2) · Lentivirus Infections (2) · RNA Virus Infections (2) · Retroviridae Infections (2) · Sexually Transmitted Diseases (2)
vivitrol (8) · Naltrexone (5) · Buprenorphine (1) · Buprenorphine, Naloxone Drug Combination (1) · Escitalopram (1) · Genetic Linkage (1) · Practice Management, Medical (1) · Ribavirin (1) · Therapeutics (1)
Alkermes, Inc. (3) · Yale University (3) · Butler Hospital (2) · University of Pennsylvania (2) · Mclean Hospital (1) · NYU Langone Health (1) · New York State Psychiatric Institute (1) · Orexo AB (1) · Sorlandet Hospital HF (1) · University of Oslo (1)
United States (9) · Russia (3) · China (2) · Norway (2)
George E Woody, MD (2) · Alexander Okhapkin, Prof. (1) · Alexander Sofronov, Prof. (1) · Alexey Egorov, Prof. (1) · Andrey Anipchenko, Dr. (1) · Bernard L. Silverman, MD (1) · Edvin Zvartau, Prof. (1) · Edward Nunes, M.D. (1) · Evgeny Krupitsky, Prof. (1) · Helge Waal, MD (1) · Helge Waal, Professor (1) · Joshua D Lee, MD MSc (1) · Lynn Webster (1) · Maria Sullivan, M.D. (1)
PMID 40342086, PMID 19721480, PMID 20598836, PMID 20707781, PMID 21491290, PMID 21529928, PMID 21924552, PMID 22065255, PMID 22864399, PMID 22945623, PMID 23036218, PMID 23701526, PMID 23891461, PMID 24045030, PMID 24219166, PMID 24521036, PMID 25090173, PMID 25189089, PMID 25562462, PMID 25703440, PMID 25901451, PMID 28358754, PMID 30920187, PMID 31715440, PMID 37231479, PMID 38616571, PMID 40833692
R01DA010746 (1), R01DA014718 (1), R01DA026797 (1), R01DA027405 (1), R01DA033670 (1)