Opiate AddictionPhase 2NCT00204243
Naltrexone Implants vs. MMT Among Inmates in the Norwegian Correctional Services
A Phase 2 study testing Naltrexone and Methadone in people with Opiate Addiction, run by University of Oslo at 1 site in Norway.
Trial summary
The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants as a relapse prevention for opiate addicted inmates about to be released from prison. The experimental group is compared with a control group that commences methadone maintenance treatment before release. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opiate Addiction
- What is being tested?
- Naltrexone and Methadone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteNorway
- Study dates
- May 2005to Dec 2008
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- opiate addiction
- living in greater Oslo area
Who cannot join
- psychosis / major depression, currently not treated
- pregnancy
- liver enzymes: ASAT or ALAT > threefold above upper boundary
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Naltrexone Implants Compared to Methadone Maintenance Treatment (MMT) Among Inmates About to be Released From Prison - a Randomized Controlled Trial
The purpose of this clinical trial is to study the efficacy and safety of naltrexone implants as a relapse prevention for opiate addicted inmates about to be released from prison. The experimental group is compared with a control group that commences methadone maintenance treatment before release.
The hypothesises are that quality of life and criminal behaviour improve significantly in both groups compared to the month before incarceration. The experimental group is going to have significant less days with opioid use compared to the MMT group.
We hypothesize furthermore that the implants can prevent death related to opiate overdose up to 6 months after commenced treatment.
Read the detailed description
The probability of quick relapse to criminal activity and substance abuse after prison release is high among incarcerated opiate addicts.
We attempt to prevent relapse to opiate abuse by two different means:
Methadone Maintenance Treatment (MMT) versus Naltrexone implants, randomly allocated to two groups by sealed envelopes.
All participants may choose in which group to continue after 6 (and again after 12) months, when the implants supposedly stop releasing naltrexone.
The total treatment period is 18 months, continuation with MMT is optional after study termination.
- Conditions
- Opiate Addiction
- Being tested
- Naltrexone, Methadone
- Keywords
- naltrexone implant, methadone, inmates, randomized controlled trial
- 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.
NaltrexoneDrug
surgically implanted naltrexone releasing during 5 to 6 months
MethadoneDrug
Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day)
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone implant | Experimental | Naltrexone implant (GoMedical Inc. 6 months implant) Receives: Drug: Naltrexone |
| Methadone | Active comparator | Methadone Maintenance Treatment Receives: Drug: Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug use: self reported, urin / hair analysis
Use of heroin and other illicit drugs, self reported and in hair analyses
Measured: 6, 12 and 18 months
Secondary outcomes (2)
Distress / depression: BDI and Hopkins SCL-25
Measured: 6, 12 and 18 months
Quality of life, temporary satisfaction with life scale & self report as of ASI
Measured: 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionFeb 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Opiate AddictionStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Investigators
- Philipp Lobmaier, cand. med., Principal investigator, Unit for Addiction MedicineHelge Waal, professor, Study director, Unit for Addiction Medicine, University of OsloMichael Abdelnoor, PhD, Study chair, Ullevål University Hospital, Centre for clinical researchJørg Mørland, professor, Study chair, Division of Forensic Toxicology and Drug AbuseAsbjørg S Christophersen, MD, Study chair, Division of Forensic Toxicology and Drug Abuse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204243
- Sponsor's protocol ID
- Project B: 160115
- Status last verified
- May 2011
- First submitted
- 13 Sep 2005
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hulse GK, Arnold-Reed DE, O'Neil G, Chan CT, Hansson RC. Achieving long-term continuous blood naltrexone and 6-beta-naltrexol coverage following sequential naltrexone implants. Addict Biol. 2004 Mar;9(1):67-72. doi: 10.1080/13556210410001674112.
PubMed 15203441Hulse GK, Arnold-Reed DE, O'Neil G, Chan CT, Hansson R, O'Neil P. Blood naltrexone and 6-beta-naltrexol levels following naltrexone implant: comparing two naltrexone implants. Addict Biol. 2004 Mar;9(1):59-65. doi: 10.1080/13556210410001674103.
PubMed 15203440Hulse GK, Tait RJ, Comer SD, Sullivan MA, Jacobs IG, Arnold-Reed D. Reducing hospital presentations for opioid overdose in patients treated with sustained release naltrexone implants. Drug Alcohol Depend. 2005 Sep 1;79(3):351-7. doi: 10.1016/j.drugalcdep.2005.02.009.
PubMed 15899557Olsen L, Christophersen AS, Frogopsahl G, Waal H, Morland J. Plasma concentrations during naltrexone implant treatment of opiate-dependent patients. Br J Clin Pharmacol. 2004 Aug;58(2):219-22. doi: 10.1111/j.1365-2125.2004.02122.x.
PubMed 15255807Bachs L, Waal H. [Naltrexone in the treatment of addiction]. Tidsskr Nor Laegeforen. 2003 Jun 12;123(12):1665-7. Norwegian.
PubMed 12821984Waal H, Christophersen AS, Frogopsahl G, Olsen LH, Morland J. [Naltrexone implants--a pilot project]. Tidsskr Nor Laegeforen. 2003 Jun 12;123(12):1660-1. Norwegian.
PubMed 12821982Kornor 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 40342086Kunoe 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 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naltrexone Implants Compared to Methadone Maintenance Treatment (MMT) Among Inmates About to be Released From Prison - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00204243
- Acronym / sponsor ID
- Project B: 160115
- Conditions
- Opiate Addiction
- Keywords
- naltrexone implant, methadone, inmates, randomized controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- May 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Sep 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 a relapse prevention for opiate addicted inmates about to be released from prison. The experimental group is compared with a control group that commences methadone maintenance treatment before release.
The hypothesises are that quality of life and criminal behaviour improve significantly in both groups compared to the month before incarceration. The experimental group is going to have significant less days with opioid use compared to the MMT group.
We hypothesize furthermore that the implants can prevent death related to opiate overdose up to 6 months after commenced treatment.
Detailed description
The probability of quick relapse to criminal activity and substance abuse after prison release is high among incarcerated opiate addicts.
We attempt to prevent relapse to opiate abuse by two different means:
Methadone Maintenance Treatment (MMT) versus Naltrexone implants, randomly allocated to two groups by sealed envelopes.
All participants may choose in which group to continue after 6 (and again after 12) months, when the implants supposedly stop releasing naltrexone.
The total treatment period is 18 months, continuation with MMT is optional after study termination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone implant | Experimental | Drug: NaltrexoneNaltrexone implant (GoMedical Inc. 6 months implant) |
| Methadone | Active comparator | Drug: MethadoneMethadone Maintenance Treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- opiate addiction
- living in greater Oslo area
Key exclusion criteria (3 listed)
- psychosis / major depression, currently not treated
- pregnancy
- liver enzymes: ASAT or ALAT > threefold above upper boundary
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 |
|---|---|---|
| Naltrexonesurgically implanted naltrexone releasing during 5 to 6 months | Drug | Naltrexone implant |
| MethadoneMethadone maintenance treatment, flexible high dose (80 to 120 mg / Day) | Drug | Methadone |
Primary outcome
Drug use: self reported, urin / hair analysis
Time frame: 6, 12 and 18 months
Use of heroin and other illicit drugs, self reported and in hair analyses
2 secondary outcomes
Distress / depression: BDI and Hopkins SCL-25
Time frame: 6, 12 and 18 months
Quality of life, temporary satisfaction with life scale & self report as of ASI
Time frame: 6, 12 and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- Background: PubMed 15203441Hulse GK, Arnold-Reed DE, O'Neil G, Chan CT, Hansson RC. Achieving long-term continuous blood naltrexone and 6-beta-naltrexol coverage following sequential naltrexone implants. Addict Biol. 2004 Mar;9(1):67-72. doi: 10.1080/13556210410001674112.
- Background: PubMed 15203440Hulse GK, Arnold-Reed DE, O'Neil G, Chan CT, Hansson R, O'Neil P. Blood naltrexone and 6-beta-naltrexol levels following naltrexone implant: comparing two naltrexone implants. Addict Biol. 2004 Mar;9(1):59-65. doi: 10.1080/13556210410001674103.
- Background: PubMed 15899557Hulse GK, Tait RJ, Comer SD, Sullivan MA, Jacobs IG, Arnold-Reed D. Reducing hospital presentations for opioid overdose in patients treated with sustained release naltrexone implants. Drug Alcohol Depend. 2005 Sep 1;79(3):351-7. doi: 10.1016/j.drugalcdep.2005.02.009.
- Background: PubMed 15255807Olsen L, Christophersen AS, Frogopsahl G, Waal H, Morland J. Plasma concentrations during naltrexone implant treatment of opiate-dependent patients. Br J Clin Pharmacol. 2004 Aug;58(2):219-22. doi: 10.1111/j.1365-2125.2004.02122.x.
- Background: PubMed 12821984Bachs L, Waal H. [Naltrexone in the treatment of addiction]. Tidsskr Nor Laegeforen. 2003 Jun 12;123(12):1665-7. Norwegian.
- Background: PubMed 12821982Waal H, Christophersen AS, Frogopsahl G, Olsen LH, Morland J. [Naltrexone implants--a pilot project]. Tidsskr Nor Laegeforen. 2003 Jun 12;123(12):1660-1. Norwegian.
- Derived from this study: PubMed 40342086Kornor 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.
- 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.
Philipp Lobmaier, cand. med. principal investigator
Unit for Addiction Medicine
Helge Waal, professor study director
Unit for Addiction Medicine, University of Oslo
Michael Abdelnoor, PhD study chair
Ullevål University Hospital, Centre for clinical research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone and Methadone in people with Opiate Addiction, 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 3 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 19 May 2011. 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 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.
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: self reported, urin / hair analysis (time frame: 6, 12 and 18 months). 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 NCT00204243, which also lists 8 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 19 May 2011.