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

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Opioid Dependency Drug: Implantation of naltrexone implants Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction.
Study Start Date : May 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00269607

Sponsors and Collaborators
University of Oslo
Study Director: Helge Waal, professor Unit for addiction medicine, Institute of psychiatry, University of Oslo

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Oslo, Institute of Psychiatry, Professor Edvard Hauff, Institute of Psychiatry, University of Oslo Identifier: NCT00269607     History of Changes
Other Study ID Numbers: 11899
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2005

Keywords provided by University of Oslo:
Substance abuse
Relapse prevention
opioid antagonist

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents