Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway (NTX-SBX)

October 10, 2018 updated by: Lars Tanum, University of Oslo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Oslo University Hospital, Avdeling for Rus og Avhengighet
    • Akershus
      • Oslo, Akershus, Norway
        • Akershus University Hospital
    • Hordaland
      • Bergen, Hordaland, Norway
        • Haukeland University Hospital
    • Rogaland
      • Stavanger, Rogaland, Norway
        • Stavanger University Hospital
    • Vestfold
      • Tonsberg, Vestfold, Norway
        • Vestfold Hospital Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Naltrexone intramuscular suspension
Extended release naltrexone injections 380mg
Drug: Naltrexone intramuscular suspension
A standard dosage of 380 mg / month of naltrexone intramuscular suspension will be administered
Other Names:
  • Vivitrol
  • XR-NTX
  • Long-acting naltrexone
  • Extended-release naltrexone
Active Comparator: Buprenorphine-naloxone
Flexible oral dose 4-24 mg daily
Drug: Buprenorphine-naloxone
Buprenorphine-naloxone is administered daily and provided in accordance with existing guidelines for OMT in Norway (treatment-as-usual).
Other Names:
  • Suboxone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of other substances of abuse
Time Frame: Week 1-48
Week 1-48
Mental health
Time Frame: Week 1-12 or 1-48
Self-reported mental health
Week 1-12 or 1-48
Somatic health
Time Frame: Week 1-12 or 1-48 post discharge
Self-reported and/or assessed by study personnel
Week 1-12 or 1-48 post discharge
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.
Week 1-12, Week 1-48, & Wk 49-100

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Collaborators

Norwegian Institute of Public Health
Oslo University Hospital
The Research Council of Norway
Ostfold Hospital Trust
Helse Stavanger HF
Haukeland University Hospital
The Hospital of Vestfold
University Hospital, Akershus
The Royal Norwegian Ministry of Health

Investigators

  • Principal Investigator: Lars Tanum, MD, PhD, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

August 31, 2016

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

October 28, 2012

First Submitted That Met QC Criteria

October 28, 2012

First Posted (Estimate)

October 31, 2012

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-002858-31
  • 204725-1 (Other Grant/Funding Number: Norwegian Research Council)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Opioid Dependence

Clinical Trials on Naltrexone intramuscular suspension

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe