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

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ClinicalTrials.gov Identifier: NCT01717963
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : October 11, 2018
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

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Opioid Dependence Drug: Naltrexone intramuscular suspension Drug: Buprenorphine-naloxone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2012
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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:
  • 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


Outcome Measures
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Primary Outcome Measures :
  1. Number of biological samples negative/positive for opioid agonists [ Time Frame: Week 1-12 post discharge ]
  2. Retention [ Time Frame: Week 1-12 post discharge ]
  3. Days of use or abstinence from opioids [ Time Frame: Week 1-12 post discharge ]

Secondary Outcome Measures :
  1. Use of other substances of abuse [ Time Frame: Week 1-48 ]
  2. Mental health [ Time Frame: Week 1-12 or 1-48 ]
    Self-reported mental health

  3. Somatic health [ Time Frame: Week 1-12 or 1-48 post discharge ]
    Self-reported and/or assessed by study personnel

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717963


Locations
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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
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Principal Investigator: Lars Tanum, MD, PhD University of Oslo
More Information
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Additional Information:
Website for the Univ of Oslo Naltrexone study group (in Norwegian)  This link exits the ClinicalTrials.gov site Webpage of the study Sponsor: The Norwegian Centre for Addiction Research, Univ of Oslo  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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 ( Other Grant/Funding Number: Norwegian Research Council )
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Alcohol Deterrents