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

• Sponsor: University of Oslo (Other)
• Overall Status: Completed
• CT.gov ID: NCT01717963
• Collaborator: The Research Council of Norway (Other), The Royal Norwegian Ministry of Health (Other), Norwegian Institute of Public Health (Other), Oslo University Hospital (Other), University Hospital, Akershus (Other), Haukeland University Hospital (Other), Helse Stavanger HF (Other), The Hospital of Vestfold (Other), Ostfold Hospital Trust (Other)
• Enrollment: 166
• Locations: 5
• Arms: 2
• Duration (Months): 66.9
• Patients Per Site: 33.2
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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

• Study Type: Interventional
• 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: Oct 1, 2012
• Actual Primary Completion Date: Aug 31, 2016
• Actual Study Completion Date: Apr 30, 2018

Arms and Interventions

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 Names: Suboxone

Outcome Measures

Primary Outcome Measures

1. Number of biological samples negative/positive for opioid agonists [Week 1-12 post discharge]

2. Retention [Week 1-12 post discharge]

3. Days of use or abstinence from opioids [Week 1-12 post discharge]

Secondary Outcome Measures

1. Use of other substances of abuse [Week 1-48]

2. Mental health [Week 1-12 or 1-48]

   Self-reported mental health

3. Somatic health [Week 1-12 or 1-48 post discharge]

   Self-reported and/or assessed by study personnel

4. Psychosocial problems [Week 1-12, Week 1-48, & Wk 49-100]

   Psychosocial problems like recidivism, employment, family problems. Self-reported or registry-based.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Akershus University Hospital	Oslo	Akershus	Norway
2	Haukeland University Hospital	Bergen	Hordaland	Norway
3	Stavanger University Hospital	Stavanger	Rogaland	Norway
4	Vestfold Hospital Trust	Tonsberg	Vestfold	Norway
5	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

Study Documents (Full-Text)

None provided.

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

None provided.

• Responsible Party: Lars Tanum, National Coordinating Investigator (PI), University of Oslo
• ClinicalTrials.gov Identifier: NCT01717963
• Other Study ID Numbers: 2011-002858-31; 204725-1
• First Posted: Oct 31, 2012
• Last Update Posted: Oct 11, 2018
• Last Verified: Oct 1, 2018

• Additional relevant MeSH terms: Opioid-Related Disorders; Naltrexone; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Study Results

No Results Posted as of Oct 11, 2018