Opioid Dependence Clinical Trial
Official title:
Optimal Prevention of Overdose Deaths and Opioid Relapse Following Discharge: A Multi-Center RCT of Naltrexone Versus Buprenorphine in Norway
Persons dependent on opioids like heroin, morphine, or codeine have a high risk of relapse, overdose and overdose death. This risk is elevated even further following discharge from treatment or correctional institutions where patients have been detoxified. At the moment, state-of-the-art treatment is based on maintaining the dependence on opioids by daily intake of opioid medications like methadone or buprenorphine. Recently, a medication containing the blocking agent naltrexone was approved in the US; this does not maintain dependence but instead blocks heroin and other opioids for 28 days after intramuscular administration. This study will conduct a 12-week randomized comparison of naltrexone intramuscular suspension (XL-NTX) with daily buprenorphine-naloxone in OMT. Medication will start preceding discharge from a treatment or correctional facility to participating catchment regions in Norway. The main hypotheses are that XL-NTX will do equally well as - or better than - OMT on the proportion of biological samples negative for opioids, retention, self-reported use of alcohol and illicit drugs. Following the 12-week randomized period, there will be a 36-week period where participants can receive the study medication of their choice. After the end of the study, data from national registry databases can be collected for a further 12 months on outcomes such as recidivism, mortality and morbidity.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03675386 -
Reducing Opioid Use for Chronic Pain Patients Following Surgery
|
N/A | |
| Completed |
NCT02593474 -
Medication-Assisted Treatment for Youth With Substance Use Disorders
|
Phase 1 | |
| Completed |
NCT02282306 -
Phone Interview to Prevent Recurring Opioid Overdoses
|
N/A | |
| Completed |
NCT02294253 -
Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone
|
Phase 2/Phase 3 | |
| Completed |
NCT01592461 -
Starting Treatment With Agonist Replacement Therapies Follow-up Study
|
N/A | |
| Terminated |
NCT00768482 -
A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence
|
Phase 3 | |
| Completed |
NCT01741350 -
Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users
|
N/A | |
| Terminated |
NCT04121546 -
Collaborative Care for Opioid Dependence And Pain Pilot Study
|
N/A | |
| Withdrawn |
NCT03368794 -
Naloxone to TReatment Entry in the Emergency Setting
|
N/A | |
| Completed |
NCT03447743 -
Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder
|
Early Phase 1 | |
| Completed |
NCT04464421 -
SMART Effectiveness Trial
|
N/A | |
| Recruiting |
NCT04189523 -
Does Early Administration of Ultrasound Guided Regional Anesthesia for Long Bone Fractures Effect Long Term Patient Opioid Usage
|
N/A | |
| Completed |
NCT03305666 -
Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures
|
Phase 4 | |
| Recruiting |
NCT04003948 -
Preliminary Efficacy and Safety of Ibogaine in the Treatment of Methadone Detoxification
|
Phase 2 | |
| Not yet recruiting |
NCT03813095 -
Exploratory Dose Ranging Study Assessing APH-1501 for the Treatment of Opioid Addiction
|
Phase 2 | |
| Terminated |
NCT02935101 -
Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants
|
Phase 2 | |
| Completed |
NCT01895270 -
Improving Buprenorphine Detoxification Outcomes With Isradipine
|
Phase 1/Phase 2 | |
| Completed |
NCT02324725 -
Biomarkers of Injectable Extended Release Naltrexone Treatment
|
Phase 4 | |
| Completed |
NCT01425060 -
Improving Effective Contraceptive Use Among Opioid-maintained Women
|
Phase 1 | |
| Completed |
NCT01188421 -
Medications Development for Drug Abuse Disorders
|
Phase 1/Phase 2 |