NCT01717963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

3.9 years

First QC Date

October 28, 2012

Last Update Submit

October 10, 2018

Conditions

Opioid Dependence

Outcome Measures

Primary Outcomes (3)

  • Number of biological samples negative/positive for opioid agonists

    Week 1-12 post discharge

  • Retention

    Week 1-12 post discharge

  • Days of use or abstinence from opioids

    Week 1-12 post discharge

Secondary Outcomes (4)

  • Use of other substances of abuse

    Week 1-48

  • Mental health

    Week 1-12 or 1-48

  • Somatic health

    Week 1-12 or 1-48 post discharge

  • Psychosocial problems

    Week 1-12, Week 1-48, & Wk 49-100

Study Arms (2)

Naltrexone intramuscular suspension

EXPERIMENTAL

Extended release naltrexone injections 380mg

Drug: Naltrexone intramuscular suspension

Buprenorphine-naloxone

ACTIVE COMPARATOR

Flexible oral dose 4-24 mg daily

Drug: Buprenorphine-naloxone

Interventions

Naltrexone intramuscular suspensionDRUG

A standard dosage of 380 mg / month of naltrexone intramuscular suspension will be administered

Also known as: Long-acting naltrexone, Extended-release naltrexone, XR-NTX, Vivitrol
Naltrexone intramuscular suspension
Buprenorphine-naloxoneDRUG

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

Also known as: Suboxone
Buprenorphine-naloxone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Opioid dependence (DSM-IV TR)
  • Age 18 or above
  • Applied \& Approved for Norway's national OMT program
  • Voluntarily seeking treatment for opioid dependence

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Akershus University Hospital

Oslo, Akershus, Norway

Location

Haukeland University Hospital

Bergen, Hordaland, Norway

Location

Stavanger University Hospital

Stavanger, Rogaland, Norway

Location

Vestfold Hospital Trust

Tønsberg, Vestfold, Norway

Location

Oslo University Hospital, Avdeling for Rus og Avhengighet

Oslo, 0407, Norway

Location

Related Publications (9)

  • Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.

    PMID: 40342086DERIVED

  • Solli KK, Benth JS, Digranes LCW, Holtan L, Kunoe N, Tanum L. Changes in mental health during long-term treatment with extended-release naltrexone: A 3-year clinical study of opioid dependent individuals. Contemp Clin Trials. 2025 May;152:107861. doi: 10.1016/j.cct.2025.107861. Epub 2025 Feb 21.

    PMID: 39987958DERIVED

  • Opheim A, Benth JS, Solli KK, Kloster PS, Fadnes LT, Kunoe N, Gaulen Z, Tanum L. Risk of relapse to non-opioid addictive substances among opioid dependent patients treated with an opioid receptor antagonist or a partial agonist: A randomized clinical trial. Contemp Clin Trials. 2023 Dec;135:107360. doi: 10.1016/j.cct.2023.107360. Epub 2023 Oct 19.

    PMID: 37865138DERIVED

  • Opheim A, Gaulen Z, Solli KK, Latif ZE, Fadnes LT, Benth JS, Kunoe N, Tanum L. Risk of Relapse Among Opioid-Dependent Patients Treated With Extended-Release Naltrexone or Buprenorphine-Naloxone: A Randomized Clinical Trial. Am J Addict. 2021 Sep;30(5):453-460. doi: 10.1111/ajad.13151.

    PMID: 34487395DERIVED

  • Latif ZE, Solli KK, Opheim A, Kunoe N, Benth JS, Krajci P, Sharma-Haase K, Tanum L. No increased pain among opioid-dependent individuals treated with extended-release naltrexone or buprenorphine-naloxone: A 3-month randomized study and 9-month open-treatment follow-up study. Am J Addict. 2019 Feb;28(2):77-85. doi: 10.1111/ajad.12859. Epub 2019 Jan 31.

    PMID: 30701613DERIVED

  • Latif ZE, Saltyte Benth J, Solli KK, Opheim A, Kunoe N, Krajci P, Sharma-Haase K, Tanum L. Anxiety, Depression, and Insomnia Among Adults With Opioid Dependence Treated With Extended-Release Naltrexone vs Buprenorphine-Naloxone: A Randomized Clinical Trial and Follow-up Study. JAMA Psychiatry. 2019 Feb 1;76(2):127-134. doi: 10.1001/jamapsychiatry.2018.3537.

    PMID: 30566177DERIVED

  • Solli KK, Latif ZE, Opheim A, Krajci P, Sharma-Haase K, Benth JS, Tanum L, Kunoe N. Effectiveness, safety and feasibility of extended-release naltrexone for opioid dependence: a 9-month follow-up to a 3-month randomized trial. Addiction. 2018 Oct;113(10):1840-1849. doi: 10.1111/add.14278. Epub 2018 Jun 22.

    PMID: 29806872DERIVED

  • Tanum L, Solli KK, Latif ZE, Benth JS, Opheim A, Sharma-Haase K, Krajci P, Kunoe N. Effectiveness of Injectable Extended-Release Naltrexone vs Daily Buprenorphine-Naloxone for Opioid Dependence: A Randomized Clinical Noninferiority Trial. JAMA Psychiatry. 2017 Dec 1;74(12):1197-1205. doi: 10.1001/jamapsychiatry.2017.3206.

    PMID: 29049469DERIVED

  • Kunoe N, Opheim A, Solli KK, Gaulen Z, Sharma-Haase K, Latif ZE, Tanum L. Design of a randomized controlled trial of extended-release naltrexone versus daily buprenorphine-naloxone for opioid dependence in Norway (NTX-SBX). BMC Pharmacol Toxicol. 2016 Apr 28;17(1):18. doi: 10.1186/s40360-016-0061-1.

    PMID: 27121539DERIVED

Related Links

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

vivitrolBuprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BuprenorphineMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsNaloxoneHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Lars Tanum, MD, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
National Coordinating Investigator (PI)

Study Record Dates

First Submitted

October 28, 2012

First Posted

October 31, 2012

Study Start

October 1, 2012

Primary Completion

August 31, 2016

Study Completion

April 30, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations

NO(5)