Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway

Opioid Dependence Clinical Trial

— NTX-SBX  

Official title:

Optimal Prevention of Overdose Deaths and Opioid Relapse Following Discharge: A Multi-Center RCT of Naltrexone Versus Buprenorphine in Norway

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01717963
• Other study ID #: 2011-002858-31
• Secondary ID: 204725-1
• Status: Completed
• Phase: Phase 3
• Start date: October 2012
• Est. completion date: April 30, 2018

Study information

• Verified date: October 2018
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: April 30, 2018
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Naltrexone intramuscular suspension
A standard dosage of 380 mg / month of naltrexone intramuscular suspension will be administered
• Buprenorphine-naloxone
Buprenorphine-naloxone is administered daily and provided in accordance with existing guidelines for OMT in Norway (treatment-as-usual).

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	Hordaland
Norway	Akershus University Hospital	Oslo	Akershus
Norway	Oslo University Hospital, Avdeling for Rus og Avhengighet	Oslo
Norway	Stavanger University Hospital	Stavanger	Rogaland
Norway	Vestfold Hospital Trust	Tonsberg	Vestfold

Sponsors (10)

Lead Sponsor	Collaborator
University of Oslo	Haukeland University Hospital, Helse Stavanger HF, Norwegian Institute of Public Health, Oslo University Hospital, Ostfold Hospital Trust, The Hospital of Vestfold, The Research Council of Norway, The Royal Norwegian Ministry of Health, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of biological samples negative/positive for opioid agonists		Week 1-12 post discharge
Primary	Retention		Week 1-12 post discharge
Primary	Days of use or abstinence from opioids		Week 1-12 post discharge
Secondary	Use of other substances of abuse		Week 1-48
Secondary	Mental health	Self-reported mental health	Week 1-12 or 1-48
Secondary	Somatic health	Self-reported and/or assessed by study personnel	Week 1-12 or 1-48 post discharge
Secondary	Psychosocial problems	Psychosocial problems like recidivism, employment, family problems. Self-reported or registry-based.	Week 1-12, Week 1-48, & Wk 49-100

External Links

•   Webpage of the study Sponsor: The Norwegian Centre for Addiction Research, Univ of Oslo
•   Website for the Univ of Oslo Naltrexone study group (in Norwegian)