Naltrexone Implants as Relapse Prevention

Opioid Dependency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00269607
• Other study ID #: 11899
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: December 22, 2005
• Last updated: December 10, 2013
• Start date: May 2005
• Est. completion date: December 2006

Study information

• Verified date: December 2005
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid Dependency

Intervention

Drug:
• Implantation of naltrexone implants

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcomes: drug use at 6(12/18)months by self report, hair analysis; days in work or education, number of drug-free friends at 6 (12/18)months by self report
Secondary	Secondary Outcomes: depression at 6(12/18)months by BDI and Hopkins SCL-25; quality of life at 6(12/18)months by EuropASI