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
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Condition or disease | Intervention/treatment | Phase |
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Opioid Dependence | Drug: Naltrexone intramuscular suspension Drug: Buprenorphine-naloxone | Phase 3 |
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 |

Arm | Intervention/treatment |
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Experimental: Naltrexone intramuscular suspension
Extended release naltrexone injections 380mg
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Drug: Naltrexone intramuscular suspension
A standard dosage of 380 mg / month of naltrexone intramuscular suspension will be administered
Other Names:
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Active Comparator: Buprenorphine-naloxone
Flexible oral dose 4-24 mg daily
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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 |
- Number of biological samples negative/positive for opioid agonists [ Time Frame: Week 1-12 post discharge ]
- Retention [ Time Frame: Week 1-12 post discharge ]
- Days of use or abstinence from opioids [ Time Frame: Week 1-12 post discharge ]
- Use of other substances of abuse [ Time Frame: Week 1-48 ]
- Mental health [ Time Frame: Week 1-12 or 1-48 ]Self-reported mental health
- Somatic health [ Time Frame: Week 1-12 or 1-48 post discharge ]Self-reported and/or assessed by study personnel
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | Lars Tanum, MD, PhD | University of Oslo |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Lars Tanum, National Coordinating Investigator (PI), University of Oslo |
ClinicalTrials.gov Identifier: | NCT01717963 |
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 |
Opioid-Related Disorders Narcotic-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 |