Naltrexone Implants as Relapse Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00269607
Recruitment Status : Terminated (Recruitment difficulties. Reframed as pilot study)
First Posted : December 23, 2005
Last Update Posted : December 11, 2013
Information provided by:
University of Oslo

December 22, 2005
December 23, 2005
December 11, 2013
May 2005
December 2006   (Final data collection date for 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
Same as current
Complete list of historical versions of study NCT00269607 on Archive Site
Secondary Outcomes: depression at 6(12/18)months by BDI and Hopkins SCL-25; quality of life at 6(12/18)months by EuropASI
Same as current
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Naltrexone Implants as Relapse Prevention
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.

Not Provided
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Opioid Dependency
Drug: Implantation of naltrexone implants
Not Provided
Kunøe N, Lobmaier P, Vederhus JK, Hjerkinn B, Gossop M, Hegstad S, Kristensen Ø, 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2006
December 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • psychosis / major depression, currently not treated
  • pregnancy
  • liver enzymes: ASAT or ALAT > threefold above upper boundary
  • maintenance treatment with methadone or buprenorphine
Sexes Eligible for Study: All
19 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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University of Oslo, Institute of Psychiatry, Professor Edvard Hauff, Institute of Psychiatry, University of Oslo
University of Oslo
Not Provided
Study Director: Helge Waal, professor Unit for addiction medicine, Institute of psychiatry, University of Oslo
University of Oslo
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP