Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway

Overview

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.

Full Title of Study: “Optimal Prevention of Overdose Deaths and Opioid Relapse Following Discharge: A Multi-Center RCT of Naltrexone Versus Buprenorphine in Norway”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2016

Interventions

  • Drug: Naltrexone intramuscular suspension
    • A standard dosage of 380 mg / month of naltrexone intramuscular suspension will be administered
  • Drug: Buprenorphine-naloxone
    • Buprenorphine-naloxone is administered daily and provided in accordance with existing guidelines for OMT in Norway (treatment-as-usual).

Arms, Groups and Cohorts

  • Experimental: Naltrexone intramuscular suspension
    • Extended release naltrexone injections 380mg
  • Active Comparator: Buprenorphine-naloxone
    • Flexible oral dose 4-24 mg daily

Clinical Trial Outcome Measures

Primary Measures

  • Number of biological samples negative/positive for opioid agonists
    • Time Frame: Week 1-12 post discharge
  • Retention
    • Time Frame: Week 1-12 post discharge
  • Days of use or abstinence from opioids
    • Time Frame: Week 1-12 post discharge

Secondary Measures

  • Use of other substances of abuse
    • Time Frame: Week 1-48
  • Mental health
    • Time Frame: Week 1-12 or 1-48
    • Self-reported mental health
  • Somatic health
    • Time Frame: Week 1-12 or 1-48 post discharge
    • Self-reported and/or assessed by study personnel
  • Psychosocial problems
    • Time Frame: Week 1-12, Week 1-48, & Wk 49-100
    • Psychosocial problems like recidivism, employment, family problems. Self-reported or registry-based.

Participating in This Clinical Trial

Inclusion Criteria

  • Opioid dependence (DSM-IV TR) – Age 18 or above – Applied & Approved for Norway's national OMT program – Discharge within 30 days of inclusion from a controlled environment; e.g. inpatient treatment or correctional (prison) facility – Voluntarily seeking treatment for opioid dependence Exclusion Criteria:

  • Pregnant or breast-feeding – Acute or recurring severe psychiatric disorder, e.g. psychosis, suicidality – Serious debilitation of liver or renal function (e.g. Child-Pugh level C) – Use of excluded medication – Known intolerance to study drugs or their ingredients – Employment in firm manufacturing one of the study drugs or close relation to such person

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Oslo
  • Collaborator
    • The Research Council of Norway
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lars Tanum, National Coordinating Investigator (PI) – University of Oslo
  • Overall Official(s)
    • Lars Tanum, MD, PhD, Principal Investigator, University of Oslo

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