Clinical trial NCT00204243: Naltrexone Implants vs. MMT Among Inmates in the Norwegian Correctional Services
Official title: Naltrexone Implants Compared to Methadone Maintenance Treatment (MMT) Among Inmates About to be Released From Prison - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opiate Addiction
Keywords: naltrexone implant
methadone
inmates
randomized controlled trial
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2005-09-20
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* opiate addiction
* living in greater Oslo area

Exclusion Criteria:

* psychosis / major depression, currently not treated
* pregnancy
* liver enzymes: ASAT or ALAT \> threefold above upper boundary

Primary outcomes:
measure: Drug use: self reported, urin / hair analysis
timeFrame: 6, 12 and 18 months
Secondary outcomes:
measure: Distress / depression: BDI and Hopkins SCL-25
timeFrame: 6, 12 and 18 months
measure: Quality of life, temporary satisfaction with life scale & self report as of ASI
timeFrame: 6, 12 and 18 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Unit for Addiction Medicine
Study officials:
affiliation: Unit for Addiction Medicine
name: Philipp Lobmaier, cand. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Unit for Addiction Medicine, University of Oslo
name: Helge Waal, professor
role: STUDY_DIRECTOR
affiliation: Ullevål University Hospital, Centre for clinical research
name: Michael Abdelnoor, PhD
role: STUDY_CHAIR
affiliation: Division of Forensic Toxicology and Drug Abuse
name: Jørg Mørland, professor
role: STUDY_CHAIR
affiliation: Division of Forensic Toxicology and Drug Abuse
name: Asbjørg S Christophersen, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Bachs L, Waal H. [Naltrexone in the treatment of addiction]. Tidsskr Nor Laegeforen. 2003 Jun 12;123(12):1665-7. Norwegian.
citation: 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.
citation: 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.