Naltrexone Implants as Relapse Prevention

This study has been terminated.
(Recruitment difficulties. Reframed as pilot study)
Sponsor:
Information provided by:
University of Oslo
ClinicalTrials.gov Identifier:
NCT00269607
First received: December 22, 2005
Last updated: December 10, 2013
Last verified: December 2005
  Purpose

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 Intervention Phase
Opioid Dependency
Drug: Implantation of naltrexone implants
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction.

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • 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:
  • Secondary Outcomes: depression at 6(12/18)months by BDI and Hopkins SCL-25; quality of life at 6(12/18)months by EuropASI

Enrollment: 12
Study Start Date: May 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00269607

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

No publications provided by University of Oslo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Oslo, Institute of Psychiatry, Professor Edvard Hauff, Institute of Psychiatry, University of Oslo
ClinicalTrials.gov Identifier: NCT00269607     History of Changes
Other Study ID Numbers: 11899
Study First Received: December 22, 2005
Last Updated: December 10, 2013
Health Authority: Norway: Norwegian Medicines Agency

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

Additional relevant MeSH terms:
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014