Opioid DependencyPhase 2/3NCT00269607
Naltrexone Implants as Relapse Prevention
A Phase 2/3 study testing Implantation of naltrexone implants in people with Opioid Dependency, run by University of Oslo.
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
- Opioid Dependency
- What is being tested?
- Implantation of naltrexone implants
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Dec 2006
- 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
About this study
Official title: Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction.
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 in the naltrexone experimental group are prematched in a pairwise fashion with other patients who do not want a naltrexone implant during the first six months after ending inpatient treatment, but who reiceive treatment as usual (TAU) from the Norwegian healthcare system.
The hypotheses are that quality of life, depression, opioid use, will be significantly better in the naltrexone group compared to the non at 6-, 12-, and 18-month follow-up.
We also hypothesize that the implants can prevent death from opioid overdose up to 6 months after commenced treatment.
- Conditions
- Opioid Dependency
- Being tested
- Implantation of naltrexone implants
- Keywords
- Substance abuse, Treatment, Relapse prevention, opioid antagonist
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of naltrexone implantsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcomes: drug use at 6(12/18)months by self report, hair analysis; days in work or education, number of drug-free friends at 6 (12/18)months by self report
Secondary outcomes (1)
Secondary Outcomes: depression at 6(12/18)months by BDI and Hopkins SCL-25; quality of life at 6(12/18)months by EuropASI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startMay 2005
- Primary completionDec 2006
- Study completionDec 2006
Why it stopped: Recruitment difficulties. Reframed as pilot study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid DependencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Investigators
- Helge Waal, professor, Study director, Unit for addiction medicine, Institute of psychiatry, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269607
- Sponsor's protocol ID
- 11899
- Status last verified
- Dec 2005
- First submitted
- 22 Dec 2005
- Last updated
- 11 Dec 2013
- Results posted
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction.
- ClinicalTrials.gov ID
- NCT00269607
- Acronym / sponsor ID
- 11899
- Conditions
- Opioid Dependency
- Keywords
- Substance abuse, Treatment, Relapse prevention, opioid antagonist
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties. Reframed as pilot study
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 23 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 in the naltrexone experimental group are prematched in a pairwise fashion with other patients who do not want a naltrexone implant during the first six months after ending inpatient treatment, but who reiceive treatment as usual (TAU) from the Norwegian healthcare system.
The hypotheses are that quality of life, depression, opioid use, will be significantly better in the naltrexone group compared to the non at 6-, 12-, and 18-month follow-up.
We also hypothesize that the implants can prevent death from opioid overdose up to 6 months after commenced treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- soon to complete inpatient treatment for opioid addiction
- living in southern Norway
Key exclusion criteria (4 listed)
- psychosis / major depression, currently not treated
- pregnancy
- liver enzymes: ASAT or ALAT > threefold above upper boundary
- maintenance treatment with methadone or buprenorphine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of naltrexone implants | Drug | – |
Primary outcome
Primary Outcomes: drug use at 6(12/18)months by self report, hair analysis; days in work or education, number of drug-free friends at 6 (12/18)months by self report
1 secondary outcome
Secondary Outcomes: depression at 6(12/18)months by BDI and Hopkins SCL-25; quality of life at 6(12/18)months by EuropASI
Results and safety
The study was stopped early (reason given: Recruitment difficulties. Reframed as pilot study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Derived from this study: PubMed 20707781Kunoe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helge Waal, professor study director
Unit for addiction medicine, Institute of psychiatry, University of Oslo
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Implantation of naltrexone implants in people with Opioid Dependency, run by University of Oslo.
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: stopped early, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Recruitment difficulties. Reframed as pilot study). Results are not available in the source record.
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?
Primary Outcomes: drug use at 6(12/18)months by self report, hair analysis; days in work or education, number of drug-free friends at 6 (12/18)months by self report. 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 NCT00269607, which also lists 1 linked publication.
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 Dec 2013.