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| Name | Class |
|---|---|
| The Research Council of Norway | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone implant | Experimental | Naltrexone implant (GoMedical Inc. 6 months implant) |
|
| Methadone | Active Comparator | Methadone Maintenance Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone | Drug | surgically implanted naltrexone releasing during 5 to 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Drug use: self reported, urin / hair analysis | Use of heroin and other illicit drugs, self reported and in hair analyses | 6, 12 and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Distress / depression: BDI and Hopkins SCL-25 | 6, 12 and 18 months | |
| Quality of life, temporary satisfaction with life scale & self report as of ASI | 6, 12 and 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philipp Lobmaier, cand. med. | Unit for Addiction Medicine | Principal Investigator |
| Helge Waal, professor | Unit for Addiction Medicine, University of Oslo | Study Director |
| Michael Abdelnoor, PhD | Ullevål University Hospital, Centre for clinical research | Study Chair |
| Jørg Mørland, professor | Division of Forensic Toxicology and Drug Abuse | Study Chair |
| Asbjørg S Christophersen, MD | Division of Forensic Toxicology and Drug Abuse | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit for Addiction Medicine | Oslo | 0407 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15203441 | Background | 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. | |
| 15203440 | Background | Hulse 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. |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| D008691 | Methadone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Methadone |
| Drug |
Methadone maintenance treatment, flexible high dose (80 to 120 mg / Day) |
|
| 15899557 | Background | Hulse 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. |
| 15255807 | Background | Olsen 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. |
| 12821984 | Background | Bachs L, Waal H. [Naltrexone in the treatment of addiction]. Tidsskr Nor Laegeforen. 2003 Jun 12;123(12):1665-7. Norwegian. |
| 12821982 | Background | Waal 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. |
| 40342086 | Derived | 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. |
| 20707781 | Derived | 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. |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D007659 | Ketones |
| D009930 | Organic Chemicals |