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Opioid Dependence | Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway

Opioid Dependence research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Opioid dependence (DSM-IV TR) - Age 18 or above - Applied 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Opioid Dependence

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Naltrexone intramuscular suspensionA standard dosage of 380 mg / month of naltrexone intramuscular suspension will be administered

Drug:Buprenorphine-naloxoneBuprenorphine-naloxone is administered daily and provided in accordance with existing guidelines for OMT in Norway (treatment-as-usual).

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Naltrexone intramuscular suspensionExtended release naltrexone injections 380mg

Buprenorphine-naloxoneFlexible oral dose 4-24 mg daily

Study Status

Completed

Start Date: October 2012

Completed Date: April 30, 2018

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Number of biological samples negative/positive for opioid agonists

Secondary Outcome: Use of other substances of abuse

Study sponsors, principal investigator, and references

Principal Investigator: Lars Tanum, MD, PhD

Lead Sponsor: University of Oslo

Collaborator: The Research Council of Norway

More information:https://clinicaltrials.gov/show/NCT01717963

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