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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Oslo
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
Vestfold Hospital Trust
Ostfold Hospital Trust
Information provided by (Responsible Party):
Lars Tanum, University of Oslo
ClinicalTrials.gov Identifier:
NCT01717963
First received: October 28, 2012
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

Persons dependent on opioids like heroin, morphine, or codeine have a high risk of 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. In addition to the randomized groups, persons who fulfill inclusion criteria but decline medical treatment for opioid dependence will be asked to participate in an unrandomized control group without study medication and with less frequent data collection. 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: Factorial 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: First 12 weeks post discharge ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: Week 1-48 ] [ Designated as safety issue: No ]
    A mortality comparison is made between medicated groups (pooled together) and the non-medicated group


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.


Estimated Enrollment: 220
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naltrexone intramuscular suspension 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 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
No Intervention: Voluntarily unmedicated
Participants in this group are opioid dependent but express no interest in medical treatment at time of inclusion. They consent to a limited collection of data in the study and are not randomized to a study medication.

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Contacts
Contact: Lars Tanum, MD, PhD lars.tanum@medisin.uio.no
Contact: Nikolaj Kunøe, PhD nikolaj.kunoe@medisin.uio.no

Locations
Norway
Akershus University Hospital Recruiting
Oslo, Akershus, Norway
Contact: Lars Tanum, MD, PhD, DmSci       lars.tanum@ahus.no   
Principal Investigator: Lars Tanum, MD, PhD, DmSci         
Sub-Investigator: Zill-e-Huma Latif, MD         
Haukeland University Hospital Recruiting
Bergen, Hordaland, Norway
Contact: Arild Opheim       arild.opheim@helse-bergen.no   
Principal Investigator: Ola Jøsendal, MD, PhD         
Stavanger University Hospital Recruiting
Stavanger, Rogaland, Norway
Contact: Sverre Nesvåg, PhD       ness@sus.no   
Principal Investigator: Kristian Larsen, MD         
Vestfold Hospital Trust Recruiting
Tonsberg, Vestfold, Norway
Contact: Kamni Sharma, MD       kamsha@siv.no   
Principal Investigator: Kamni Sharma, MD         
Oslo University Hospital, Avdeling for Rus og Avhengighet Recruiting
Oslo, Norway, 0407
Contact: Live Sanderud, MD       l.s.stavseth@medisin.uio.no   
Principal Investigator: Peter Krajci, MD         
Sub-Investigator: Live S Stavseth, MD         
Østfold Hospital Trust Recruiting
Fredrikstad, Østfold, Norway
Contact: Merete Møller, RN       merete.moller@so-hf.no   
Principal Investigator: Arild Schillinger, MD         
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
Vestfold Hospital Trust
Ostfold Hospital Trust
Investigators
Principal Investigator: Lars Tanum, MD, PhD University of Oslo, Norway
  More Information

Additional Information:
No publications provided

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: June 3, 2013
Health Authority: Norway: Norwegian Medicines Agency

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

ClinicalTrials.gov processed this record on October 16, 2014