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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Alkermes
Information provided by (Responsible Party):
Wim van den Brink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01471145
First received: November 10, 2011
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Opioid-Related Disorders
Heroin Dependence
Drug: Naltrexone
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
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)
Arms Assigned Interventions
Experimental: Depot Naltrexone Drug: Naltrexone
naltrexone for extended-release injectable suspension, 380 mg/vial, every 4 weeks or once a month
Other Name: Vivitrol

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471145

Locations
Netherlands
Academic Medical Center Recruiting
Amsterdam, Netherlands, P.O. Box 22660
Contact: Wim van den Brink, MD PhD    +31-20-89113634    w.vandenbrink@amc.uva.nl   
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         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
Alkermes
Investigators
Principal Investigator: Wim van den Brink, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Publications:

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
Study First Received: November 10, 2011
Last Updated: January 30, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by 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:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014