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Opiate DependencePhase 2/3NCT00521157

Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction

A Phase 2/3 study testing Go Medical Naltrexone implants in people with Opiate Dependence, run by University of Oslo at 1 site 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

The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants as relapse prevention for patients that are completing treatment for opiate addiction in inpatient (or similarly controlled) settings. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Opiate Dependence
What is being tested?
Go Medical Naltrexone implants
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteNorway
Study dates
Jan 2006to Dec 2008
Phase
Phase 2/3
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • soon to complete inpatient treatment for opioid addiction
  • living in southern Norway

Who cannot join

  • psychosis/major depression, currently not treated
  • pregnancy
  • liver enzymes: ASAT or ALAT > threefold above upper boundary
  • maintenance treatment with methadone or buprenorphine

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Unit for Addiction Medicine, University of Oslo

    Oslo, N-0407

Other trials in Norway

About this study

Official title: Naltrexone Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction - a Randomised Study

The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants as relapse prevention for patients that are completing treatment for opiate addiction in inpatient (or similarly controlled) settings. Participants volunteer for the study before being released from inpatient treatment, and are randomized to a naltrexone implant group or a waiting-list control for the duration of the first six months following completion of inpatient treatment. Both groups are free to receive treatment as usual (TAU) from the Norwegian healthcare system. After six months, both groups will be offered to have naltrexone implanted for the remaining six months of the study.

The hypotheses are that quality of life, depression, opioid use, will be significantly better in the naltrexone group compared to the non at 6-month follow-up. For the last six months of the trial, the investigators hypothesise that choice of naltrexone implant will mainly strengthen positive tendencies or reverse negative trends on the aforementioned variables.

The investigators also hypothesize that the implants can prevent death from opioid overdose up to 6 months after commenced treatment.

Being tested
Go Medical Naltrexone implants
Keywords
Substance abuse, Opiate dependency, Treatment, Relapse prevention
Medical subject headings
Opioid-Related Disorders, Substance-Related Disorders

What participants receive

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

  • Go Medical Naltrexone implantsDrug

    Also called Go Medical naltrexone implant

    Naltrexone implants 3.2 g (double of 1,6 g)

Study groups in NCT00521157
Study groupRoleWhat they receive
interventionExperimentalExperimental group randomised after abstinence oriented treatment
Receives: Drug: Go Medical Naltrexone implants
2No interventionwaiting list control

What is being measured

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

  1. Drug use at 6 (12) months by self report and hair analysis

    Measured: 6 and 12 months

  2. Days in work or education

    Measured: 6 and 12 months

  3. Number of drug-free friends at 6 (12) months by self report

    Measured: 6 and 12 months

Secondary outcomes (2)

  1. Depression at 6 (12) months by BDI and Hopkins SCL-25

    Measured: 6 and 12 months

  2. Quality of life at 6 (12) months by EuropASI

    Measured: 6 and 12 months

Timeline

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

  1. First posted27 Aug 2007 (estimated)
  2. Study startJan 2006
  3. Primary completionJun 2008
  4. Study completionDec 2008

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00521157
Sponsor's protocol ID
11899 revised
Status last verified
May 2009
First submitted
24 Aug 2007
Last updated
5 May 2009
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

  • Kunoe N, Lobmaier P, Vederhus JK, Hjerkinn B, Gossop M, Hegstad S, Kristensen O, Waal H. Challenges to antagonist blockade during sustained-release naltrexone treatment. Addiction. 2010 Sep;105(9):1633-9. doi: 10.1111/j.1360-0443.2010.03031.x.

    PubMed 20707781

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Go Medical Naltrexone implants in people with Opiate Dependence, run by University of Oslo at 1 site 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 2 inclusion and 4 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 5 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Drug use at 6 (12) months by self report and hair analysis (time frame: 6 and 12 months). 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 NCT00521157, which also lists 2 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 5 May 2009.

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