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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01471145
Recruitment Status : Completed
First Posted : November 15, 2011
Last Update Posted : October 13, 2014
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Heroin Dependence Drug: Naltrexone Phase 4

Detailed Description:
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.

Study Design

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
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heroin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Depot Naltrexone Drug: Naltrexone
naltrexone for extended-release injectable suspension, 380 mg/vial, every 4 weeks or once a month
Other Name: Vivitrol

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Heroin dependent patients: have a diagnosis of opioid dependence according to DSM-IV criteria, heroin as primary drug of abuse and inhalation as primary route of administration.
  • Healthy controls: no diagnosis of substance dependence, no current psychotropic medication. Care will be taken to match controls for gender, age, smoking status, IQ and handedness.

Exclusion Criteria:

  • Age below 18 or over 55
  • Medical contraindications for XRNT or MRI (Langleben 2006; Langleben, Ruparel et al. 2008). Briefly, the former include candidates with known hypersensitivity to naltrexone,PLG (poly-lactide-coglycolide), carboxymethylcellulose, or any other components of the Vivitrol® diluent, hepatic or renal disease, chronic pain syndromes, female subjects who are pregnant or lactating, or are of child bearing potential and are not using an acceptable method of birth control. MRI contraindications include chronic medical (neurological, cardiovascular, infectious, metabolic, etc) conditions that may affect the brain morphology and/or activity and indwelling foreign metallic or magnetically sensitive objects and devices, such as shrapnel, pacemakers, orthopaedic fixation devices or vascular stents
  • Presence of disorders precluding normal perception of visual and auditory stimuli, such as color blindness, deafness, severe myopia, etc.
  • Patients with a history of or current psychosis or current major depressive disorder with suicidal ideation
  • Patients who are being treated under forced treatment conditions
  • History or evidence of disorders that may affect cerebral function or circulation, such as diabetes and other metabolic disorders, encephalopathy, cardiovascular or cerebrovascular disease, history of head trauma with depressed skull fracture or prolonged loss of consciousness and history of brain surgery
  • Female subjects: women who are pregnant or breast-feeding
  • Current psychotropic medication
  • Use of any prescription medications that could affect alertness or the circulatory system
  • IQ < 70
  • Naltrexone use within the past 6 months
  • Baseline aspartate aminotransferase or alanine aminotransferase more than three times the upper limit of normal
  • Patients with no intention to be opioid-free for a minimum of 7 days before starting XRNT treatment
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
Alkermes, Inc.
Principal Investigator: Wim van den Brink, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
More Information


Responsible Party: Wim van den Brink, Prof. dr. W. van den Brink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01471145     History of Changes
Other Study ID Numbers: 60-60600-97-301
2011-001890-15 ( EudraCT Number )
First Posted: November 15, 2011    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014

Keywords provided by Wim van den Brink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
opioid dependence
heroin dependence
extended release depot naltrexone
functional Magnetic Resonance Imaging
dopamine transporter
Single Photon Emission Computed Tomography

Additional relevant MeSH terms:
Opioid-Related Disorders
Heroin Dependence
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents