NCT01471145

Depot Naltrexone Mechanism of Action in Heroin Dependent Patients Using fMRI and SPECT

Feasibility, Mechanism of Action and Potential Side Effects of Extended Release Depot Naltrexone in Opioid Dependent Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The aim of this project is to study brain functions of 20 heroin addicts (compared to brain functions of 20 healthy controls) just before and during a three month extended release naltrexone treatment using functional MRI and dopamine transporter SPECT. The following hypotheses are tested: * XRNT modulates the fMRI response to drug cues in predetermined brain regions. * The expression of striatal transporters (assessed with SPECT) will decrease after a three-month course of extended release naltrexone

Detailed description

Heroin dependence is a quintessential international health problem, with a significant prevalence. Drug free treatments, including pharmacologically supported interventions using oral naltrexone, have not been very successful, mainly due to low compliance. The recent introduction of Vivitrol®, consisting of monthly injections, may create new opportunities. Vivitrol® is an innovative treatment delivery method that blocks the rewarding effects of heroin.

Conditions

• Opioid-Related Disorders
• Heroin Dependence

Interventions

Type	Name	Description
DRUG	Naltrexone	naltrexone for extended-release injectable suspension, 380 mg/vial, every 4 weeks or once a month

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2011-11-15
• Last updated: 2014-10-13

Locations

1 site across 1 country: Netherlands