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Biomarkers of Injectable Extended Release Naltrexone Treatment

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: NCT02324725
Recruitment Status : Active, not recruiting
First Posted : December 24, 2014
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
This study evaluates the biological markers of treatment of opioid dependent individuals with an extended release formulation of the opioid antagonist naltrexone. The biological measures include functional MRI, blood levels of naltrexone and its metabolites, urine toxicology and behavioral tests probing various aspects of personality, memory, reward processing and attention.

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

Detailed Description:
This study is using blood oxygenation level dependent (BOLD) functional magnetic resonance imaging (fMRI) to examine the brain predictors of adherence and outcomes of opioid antagonist therapy. Opioid-dependent intravenous heroin users are offered up to 3 monthly injections of the extended-release naltrexone (XRNTX) contingent upon successful outpatient non-opioid detoxification, with an additional 4 weeks of follow up. Brain responses to heroin-related pictures are recorded using fMRI prior to the 1st XRNTX injection and approximately 2 weeks thereafter the 1st XRNTX injection. Primary clinical variables include the number of injections (maximum of 3) accepted by participants, change in self-reported craving for opioids after exposure to drug-related visual cues during the brain fMRI sessions, urine levels of ten commonly abused substances and self-report of cigarette use.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biomarkers of Disease and Response to Treatment in Opioid Addiction
Study Start Date : October 2011
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Naltrexone Intervention
Eligible participants receive up to three monthly injections of 380 mg of naltrexone contained in dissolvable polymer microspheres and administered by deep intramuscular injection and slowly released over a period of approximately 4 weeks.
Drug: Naltrexone
Up to three monthly injections of 380 mg of naltrexone suspended in dissolvable polymer microspheres and administered intramuscularly
Other Name: Vivitrol ®




Primary Outcome Measures :
  1. Brain response to heroin-related visual cues [ Time Frame: 1 hour ]
    Brain, behavioral and motivational (e.g. craving) response to audiovisual drug-related and control stimuli (images, smells and sounds) and to standard tasks of decision making, self-appraisal, response inhibition, social interaction and reward processing.


Secondary Outcome Measures :
  1. Cigarettes smoked per day [ Time Frame: 6 months ]
    behavioral

  2. Urine toxicology [ Time Frame: 6 months ]
    Urine toxicology for methamphetamine, amphetamines, cannabis, cocaine, oxycodone, buprenophine, methadone, opioids, benzodiazepines and barbiturates.

  3. Injections [ Time Frame: 3 months ]
    Number of injections (maximum of 3) accepted by participants

  4. Motivational response to opioid-related visual cues measured by self-reported craving for opioids [ Time Frame: 2 hours ]
    Change in self-reported craving for opioids after exposure to opioid-related visual cues during functional MRI sessions



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:   No
Criteria

Inclusion Criteria:

  1. DSM-IV-TR diagnosis of opioid dependence, active opioid use, confirmed by urine toxicology screen and self-reported monthly intravenous heroin use for more than 2 weeks in the past 3 months
  2. urine toxicology screen negative for opioids after detoxification
  3. good physical health as indicated by history and physical examination, screening blood work-up and urinalysis.

Exclusion Criteria:

  1. chronic medical illnesses;
  2. current use of medications potentially confounding brain activity, such as anti-dopaminergic agents, anti-depressants and beta-blockers;
  3. current DSM-IV-TR Axis I psychiatric disorders other than opioid and nicotine dependence;
  4. life time history of concurrent IV cocaine and heroin (speedball) administration;
  5. pregnancy or breastfeeding;
  6. history of clinically significant head trauma;
  7. contraindications for naltrexone treatment including medical conditions requiring opioid analgesics, e.g. chronic pain or planned surgery, obesity, elevated liver enzymes (> 3 times upper limit of normal), failure to complete opioid detoxification
  8. contraindications for MRI, i.e. indwelling magnetically active foreign bodies and phobia to enclosed spaces

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): NCT02324725


Locations
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United States, Pennsylvania
Center for the Studies of Addiction
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Daniel Langleben, MD Co-Investigator
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02324725    
Other Study ID Numbers: 814234
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Pennsylvania:
naltrexone
neuroimaging
heroin
addiction
dependence
opioid
Vivitrol®
functional magnetic resonance imaging
Additional relevant MeSH terms:
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Opioid-Related Disorders
Heroin Dependence
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents