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Naltrexone Implants as Relapse Prevention

NCT00269607 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-12-11

No results posted yet for this study

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.

Conditions

  • Opioid Dependency

Interventions

DRUG

Implantation of naltrexone implants

Sponsors & Collaborators

  • University of Oslo

    lead OTHER

Principal Investigators

  • Helge Waal, professor · Unit for addiction medicine, Institute of psychiatry, University of Oslo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2006-12-31
Completion
2006-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00269607 on ClinicalTrials.gov