Depot Naltrexone Mechanism of Action in Heroin Dependent Patients Using fMRI and SPECT (XRNT)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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)|