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Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction

This study has been completed.
Sponsor:
Information provided by:
University of Oslo
ClinicalTrials.gov Identifier:
NCT00521157
First received: August 24, 2007
Last updated: May 4, 2009
Last verified: May 2009
History of Changes
  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 volunteer for the study before being released from inpatient treatment, and are randomized to a naltrexone implant group or a waiting-list control for the duration of the first six months following completion of inpatient treatment. Both groups are free to receive treatment as usual (TAU) from the Norwegian healthcare system. After six months, both groups will be offered to have naltrexone implanted for the remaining six months of the study.

The hypotheses are that quality of life, depression, opioid use, will be significantly better in the naltrexone group compared to the non at 6-month follow-up. For the last six months of the trial, the investigators hypothesise that choice of naltrexone implant will mainly strengthen positive tendencies or reverse negative trends on the aforementioned variables.

The investigators also hypothesize that the implants can prevent death from opioid overdose up to 6 months after commenced treatment.


Condition Intervention Phase
Opiate Dependence
 Drug: Go Medical Naltrexone implants
 Phase 2
Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Drug use at 6 (12) months by self report and hair analysis [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Days in work or education [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Number of drug-free friends at 6 (12) months by self report [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression at 6 (12) months by BDI and Hopkins SCL-25 [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Quality of life at 6 (12) months by EuropASI [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: January 2006
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intervention
Experimental group randomised after abstinence oriented treatment
 Drug: Go Medical Naltrexone implants
Naltrexone implants 3.2 g (double of 1,6 g)
Other Name: Go Medical naltrexone implant
No Intervention: 2
waiting list control

  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: NCT00521157

Locations
Norway
Unit for Addiction Medicine, University of Oslo
Oslo, Norway, N-0407
Sponsors and Collaborators
University of Oslo
Investigators
Study Director: Helge Waal, Professor Unit for addiction medicine, Institute of psychiatry, University of Oslo
Study Director: Helge Waal, MD Norwegian Medical Association
  More Information

No publications provided by University of Oslo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Helge Waal, MD, Professor, Head of Center for Addiction Research, University of Oslo, Institute of Psychiatry, University of Oslo
ClinicalTrials.gov Identifier: NCT00521157     History of Changes
Other Study ID Numbers: 11899 revised
Study First Received: August 24, 2007
Last Updated: May 4, 2009
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by University of Oslo:
Substance abuse
Opiate dependency
Treatment
Relapse prevention

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Analgesics, Opioid
Narcotic Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on June 17, 2013