Depot Naltrexone Mechanism of Action in Heroin Dependent Patients Using fMRI and SPECT (XRNT)
|ClinicalTrials.gov Identifier: NCT01471145|
Recruitment Status : Completed
First Posted : November 15, 2011
Last Update Posted : October 13, 2014
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
|Condition or disease||Intervention/treatment||Phase|
|Opioid-Related Disorders Heroin Dependence||Drug: Naltrexone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
|Experimental: Depot Naltrexone||
naltrexone for extended-release injectable suspension, 380 mg/vial, every 4 weeks or once a month
Other Name: Vivitrol
- Brain functions [ Time Frame: 3 months ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471145
|Academic Medical Center|
|Amsterdam, Netherlands, P.O. Box 22660|
|Principal Investigator:||Wim van den Brink, MD PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|