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Opioid DependencePhase 3NTX-SBXNCT01717963

Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway

A Phase 3 study testing Naltrexone intramuscular suspension and Buprenorphine-naloxone in people with Opioid Dependence, run by University of Oslo at 5 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid Dependence
What is being tested?
Naltrexone intramuscular suspension and Buprenorphine-naloxone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
5 sitesNorway
Study dates
Oct 2012to 30 Apr 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Norway5 sites

  • Haukeland University Hospital

    Bergen, Hordaland

  • Akershus University Hospital

    Oslo, Akershus

  • Oslo University Hospital, Avdeling for Rus og Avhengighet

    Oslo, 0407

  • Stavanger University Hospital

    Stavanger, Rogaland

  • Vestfold Hospital Trust

    Tønsberg, Vestfold

Other trials in Norway

About this study

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

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.

Being tested
Naltrexone intramuscular suspension, Buprenorphine-naloxone
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Naltrexone intramuscular suspensionDrug

    Also called Long-acting naltrexone, Extended-release naltrexone, XR-NTX, Vivitrol

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

  • Buprenorphine-naloxoneDrug

    Also called Suboxone

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

Study groups in NCT01717963
Study groupRoleWhat they receive
Naltrexone intramuscular suspensionExperimentalExtended release naltrexone injections 380mg
Receives: Drug: Naltrexone intramuscular suspension
Buprenorphine-naloxoneActive comparatorFlexible oral dose 4-24 mg daily
Receives: Drug: Buprenorphine-naloxone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of biological samples negative/positive for opioid agonists

    Measured: Week 1-12 post discharge

  2. Retention

    Measured: Week 1-12 post discharge

  3. Days of use or abstinence from opioids

    Measured: Week 1-12 post discharge

Secondary outcomes (4)

  1. Use of other substances of abuse

    Measured: Week 1-48

  2. Mental health

    Self-reported mental health

    Measured: Week 1-12 or 1-48

  3. Somatic health

    Self-reported and/or assessed by study personnel

    Measured: Week 1-12 or 1-48 post discharge

  4. Psychosocial problems

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completion31 Aug 2016
  4. Study completion30 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01717963
Sponsor's protocol ID
2011-002858-31
Other IDs
204725-1
Acronym
NTX-SBX
Status last verified
Oct 2018
First submitted
28 Oct 2012
Last updated
11 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 40342086

  • 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.

    PubMed 39987958

  • 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.

    PubMed 37865138

  • 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.

    PubMed 34487395

  • 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.

    PubMed 30701613

  • 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.

    PubMed 30566177

  • 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.

    PubMed 29806872

  • 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.

    PubMed 29049469

  • 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.

    PubMed 27121539

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Naltrexone intramuscular suspension and Buprenorphine-naloxone in people with Opioid Dependence, run by University of Oslo at 5 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of biological samples negative/positive for opioid agonists (time frame: Week 1-12 post discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01717963, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.

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