Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway (NTX-SBX)
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| ClinicalTrials.gov Identifier: NCT01717963 |
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Recruitment Status : Unknown
Verified March 2016 by Lars Tanum, University of Oslo.
Recruitment status was: Active, not recruiting
First Posted : October 31, 2012
Last Update Posted : March 23, 2016
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Sponsor:
University of Oslo
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
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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 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Opioid addiction
| 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 |
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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 |
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
Information from the National Library of Medicine
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
| 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 |
Additional Information:
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 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: | March 23, 2016 |
| Last Verified: | March 2016 |
Additional relevant MeSH terms:
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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 |