NCT00521157

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: University of Oslo · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opiate Dependence

Interventions

Type	Name	Description
DRUG	Go Medical Naltrexone implants	Naltrexone implants 3.2 g (double of 1,6 g)

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-06-01
• Completion: 2008-12-01
• First posted: 2007-08-27
• Last updated: 2009-05-05

Locations

1 site across 1 country: Norway