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

NCT01471145 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-10-13

No results posted yet for this study

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

Conditions

  • Opioid-Related Disorders
  • Heroin Dependence

Interventions

DRUG

Naltrexone

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

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Alkermes, Inc.

    collaborator INDUSTRY

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Wim van den Brink, MD PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01471145 on ClinicalTrials.gov