CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 target
Drug / intervention
Naltrexonedrug
Likely dose
Naltrexone 380 mgfrom 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/NCT01471145
NCT01471145Phase 4Completed
CompareCT.gov

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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·interventional·Posted Nov 15, 2011·Updated Oct 13, 2014

In Brief

A Phase 4 clinical trial evaluating Naltrexone for Opioid-Related Disorders and Heroin Dependence. Completed, enrolled 40 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-Related Disorders, Heroin Dependence
CountriesNetherlands
CollaboratorsZonMw: The Netherlands Organisation for Health Research and Development, Alkermes, Inc.

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 15, 2011
Enrollment StartJan 1, 2013
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.6 years ago

Interventions

Naltrexonedrug

naltrexone for extended-release injectable suspension, 380 mg/vial, every 4 weeks or once a month