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Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway

Information source: University of Oslo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opioid Dependence

Intervention: Naltrexone intramuscular suspension (Drug); Buprenorphine-naloxone (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Oslo

Official(s) and/or principal investigator(s):
Lars Tanum, MD, PhD, Principal Investigator, Affiliation: University of Oslo, Norway

Overall contact:
Lars Tanum, MD, PhD, Email: lars.tanum@medisin.uio.no

Summary

Persons dependent on opioids like heroin, morphine, or codeine have a high risk of 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. In addition to the randomized groups, persons who fulfill inclusion criteria but decline medical treatment for opioid dependence will be asked to participate in an unrandomized control group without study medication and with less frequent data collection. 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of biological samples negative/positive for opioid agonists

Retention

Mortality

Secondary outcome:

Use of other substances of abuse

Mental health

Somatic health

Psychosocial problems

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Lars Tanum, MD, PhD, Email: lars.tanum@medisin.uio.no

Oslo University Hospital, Avdeling for Rus og Avhengighet, Oslo 0407, Norway; Recruiting
Kristin K Solli, MPhil, Email: k.k.solli@medisin.uio.no
Peter Krajci, MD, Principal Investigator
Kristin K Solli, MPhil, Sub-Investigator

Akershus University Hospital, Oslo, Akershus, Norway; Recruiting
Lars Tanum, MD, PhD, DmSci, Email: lars.tanum@ahus.no
Lars Tanum, MD, PhD, DmSci, Principal Investigator
Zill-e-Huma Latif, MD, Sub-Investigator

Haukeland University Hospital, Bergen, Hordaland, Norway; Recruiting
Arild Opheim, Email: arild.opheim@helse-bergen.no
Ola Jøsendal, MD, PhD, Principal Investigator

Stavanger University Hospital, Stavanger, Rogaland, Norway; Recruiting
Sverre Nesvåg, PhD, Email: ness@sus.no
Kristian Larsen, MD, Principal Investigator

Vestfold Hospital Trust, Tonsberg, Vestfold, Norway; Recruiting
Kamni Sharma, MD, Email: kamsha@siv.no
Kamni Sharma, MD, Principal Investigator

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

Starting date: October 2012
Last updated: April 7, 2015

Page last updated: August 23, 2015

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