CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 56 enrolled
Drug / intervention
Go Medical Naltrexone implantsdrug
Likely dose
Go Medical Naltrexone implants 3.2 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00521157
NCT00521157Phase 3Completed

Naltrexone Naltrexone Implants as an Aid in Preventing Relapse Following Inpatient Treatment for Opioid Addiction - a Randomised Study

University of Oslo·interventional·Posted Aug 27, 2007·Updated May 5, 2009

In Brief

A Phase 3 clinical trial evaluating Go Medical Naltrexone implants for Opiate Dependence. Completed, enrolled 56 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNorway
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 27, 2007
Enrollment StartJan 1, 2006
Primary CompletionJun 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 18.8 years ago

Interventions

Go Medical Naltrexone implantsdrug

Naltrexone implants 3.2 g (double of 1,6 g)