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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Research Council of Norway
The Royal Norwegian Ministry of Health
Norwegian Institute of Public Health
Oslo University Hospital
University Hospital, Akershus
Haukeland University Hospital
Helse Stavanger HF
The Hospital of Vestfold
Ostfold Hospital Trust
Information provided by (Responsible Party):
Lars Tanum, University of Oslo
ClinicalTrials.gov Identifier:
NCT01717963
First received: October 28, 2012
Last updated: March 22, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Opioid Dependence
Drug: Naltrexone intramuscular suspension
Drug: Buprenorphine-naloxone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimal Prevention of Overdose Deaths and Opioid Relapse Following Discharge: A Multi-Center RCT of Naltrexone Versus Buprenorphine in Norway

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Number of biological samples negative/positive for opioid agonists [ Time Frame: Week 1-12 post discharge ] [ Designated as safety issue: No ]
  • Retention [ Time Frame: Week 1-12 post discharge ] [ Designated as safety issue: Yes ]
  • Days of use or abstinence from opioids [ Time Frame: Week 1-12 post discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Use of other substances of abuse [ Time Frame: Week 1-48 ] [ Designated as safety issue: No ]
  • Mental health [ Time Frame: Week 1-12 or 1-48 ] [ Designated as safety issue: No ]
    Self-reported mental health

  • Somatic health [ Time Frame: Week 1-12 or 1-48 post discharge ] [ Designated as safety issue: No ]
    Self-reported and/or assessed by study personnel

  • Psychosocial problems [ Time Frame: Week 1-12, Week 1-48, & Wk 49-100 ] [ Designated as safety issue: No ]
    Psychosocial problems like recidivism, employment, family problems. Self-reported or registry-based.


Enrollment: 166
Study Start Date: October 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Long-acting naltrexone
  • Extended-release naltrexone
  • XR-NTX
  • Vivitrol
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 Name: Suboxone

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717963

Locations
Norway
Akershus University Hospital
Oslo, Akershus, Norway
Haukeland University Hospital
Bergen, Hordaland, Norway
Stavanger University Hospital
Stavanger, Rogaland, Norway
Vestfold Hospital Trust
Tonsberg, Vestfold, Norway
Oslo University Hospital, Avdeling for Rus og Avhengighet
Oslo, Norway, 0407
Sponsors and Collaborators
University of Oslo
The Research Council of Norway
The Royal Norwegian Ministry of Health
Norwegian Institute of Public Health
Oslo University Hospital
University Hospital, Akershus
Haukeland University Hospital
Helse Stavanger HF
The Hospital of Vestfold
Ostfold Hospital Trust
Investigators
Principal Investigator: Lars Tanum, MD, PhD University of Oslo
  More Information

Additional Information:
Responsible Party: Lars Tanum, National Coordinating Investigator (PI), University of Oslo
ClinicalTrials.gov Identifier: NCT01717963     History of Changes
Other Study ID Numbers: 2011-002858-31  204725-1 
Study First Received: October 28, 2012
Last Updated: March 22, 2016
Health Authority: Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naltrexone
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists

ClinicalTrials.gov processed this record on August 28, 2016