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

Opiate Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00521157
• Other study ID #: 11899 revised
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 24, 2007
• Last updated: May 4, 2009
• Start date: January 2006
• Est. completion date: December 2008

Study information

• Verified date: May 2009
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• 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: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opiate Dependence

Intervention

Drug:
• Go Medical Naltrexone implants
Naltrexone implants 3.2 g (double of 1,6 g)

Locations

Country	Name	City	State
Norway	Unit for Addiction Medicine, University of Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug use at 6 (12) months by self report and hair analysis		6 and 12 months	No
Primary	Days in work or education		6 and 12 months	No
Primary	Number of drug-free friends at 6 (12) months by self report		6 and 12 months	No
Secondary	Depression at 6 (12) months by BDI and Hopkins SCL-25		6 and 12 months	No
Secondary	Quality of life at 6 (12) months by EuropASI		6 and 12 months	No