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

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ClinicalTrials.gov Identifier: NCT00521157
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : May 5, 2009
Sponsor:
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 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 or disease Intervention/treatment Phase
Opiate Dependence Drug: Go Medical Naltrexone implants Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : January 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Drug use at 6 (12) months by self report and hair analysis [ Time Frame: 6 and 12 months ]
  2. Days in work or education [ Time Frame: 6 and 12 months ]
  3. Number of drug-free friends at 6 (12) months by self report [ Time Frame: 6 and 12 months ]

Secondary Outcome Measures :
  1. Depression at 6 (12) months by BDI and Hopkins SCL-25 [ Time Frame: 6 and 12 months ]
  2. Quality of life at 6 (12) months by EuropASI [ Time Frame: 6 and 12 months ]


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
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

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 ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 27, 2007    Key Record Dates
Last Update Posted: May 5, 2009
Last Verified: May 2009

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

Additional relevant MeSH terms:
Recurrence
Opioid-Related Disorders
Disease Attributes
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents