Depot Naltrexone Mechanism of Action in Heroin Dependent Patients Using fMRI and SPECT (XRNT)
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 Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Feasibility, Mechanism of Action and Potential Side Effects of Extended Release Depot Naltrexone in Opioid Dependent Patients|
- Brain functions [ Time Frame: 3 months ] [ Designated as safety issue: No ]Brain functions of 20 heroin addicts just before and during a three month extended release naltrexone treatment using both functional MRI and dopamine transporter SPECT, compared to brain functions of 20 healthy controls.
- Feasibility and potential efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]The feasibility and potential efficacy of extended release naltrexone in a pilot sample of 20 Dutch heroin addicts in terms of (a) the percentage of patients that actually starts treatment when invited and (b) the percentage of 3 months retention.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
|Experimental: Depot Naltrexone||
naltrexone for extended-release injectable suspension, 380 mg/vial, every 4 weeks or once a month
Other Name: Vivitrol
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471145
|Academic Medical Center||Recruiting|
|Amsterdam, Netherlands, P.O. Box 22660|
|Contact: Wim van den Brink, MD PhD +31-20-89113634 firstname.lastname@example.org|
|Principal Investigator: Wim van den Brink, MD PhD|
|Sub-Investigator: Jan Booij, MD PhD|
|Sub-Investigator: Anneke E. Goudriaan, PhD|
|Sub-Investigator: Dick J. Veltman, MD PhD|
|Sub-Investigator: Eline R. Zaaijer, MD|
|Principal Investigator:||Wim van den Brink, MD PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|