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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Estimated Primary Completion Date :	May 2016
Estimated Study Completion Date :	August 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, Senior)
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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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Website for the Univ of Oslo Naltrexone study group (in Norwegian) 

Webpage of the study Sponsor: The Norwegian Centre for Addiction Research, Univ of Oslo 

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

Tanum L, Solli KK, Latif ZE, Benth JŠ, Opheim A, Sharma-Haase K, Krajci P, Kunøe N. Effectiveness of Injectable Extended-Release Naltrexone vs Daily Buprenorphine-Naloxone for Opioid Dependence: A Randomized Clinical Noninferiority Trial. JAMA Psychiatry. 2017 Dec 1;74(12):1197-1205. doi: 10.1001/jamapsychiatry.2017.3206.

Kunøe N, Opheim A, Solli KK, Gaulen Z, Sharma-Haase K, Latif ZE, Tanum L. Design of a randomized controlled trial of extended-release naltrexone versus daily buprenorphine-naloxone for opioid dependence in Norway (NTX-SBX). BMC Pharmacol Toxicol. 2016 Apr 28;17(1):18. doi: 10.1186/s40360-016-0061-1.

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
Last Update Posted:	March 23, 2016
Last Verified:	March 2016

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