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 agonistsRetention Mortality
Secondary outcome: Use of other substances of abuseMental 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
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