CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery

Study Overview
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Brief Summary
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The proposed project will use fMRI and specific probes of reward and inhibition as biomarkers predicting drug use during and after treatment in 72 subjects addicted to prescription opioids/medications. Subjects will be scanned before, during, and after 12 weeks of active medication. The brain fMRI measures will be correlated with the primary clinical outcome of drug use (by urine drug screen) during the treatment and follow-up phase.

Official Title
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CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery - Prescription Opiates/Medication

Conditions
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Prescription Opiate/Medication Dependence

Intervention / Treatment
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* Drug: Vivitrol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign an informed consent form; Be between the ages of 18 and 60; Have a diagnosis of opioid dependence according to DSM IV-TR criteria (as assessed by the MINI); Be in good general health as determined by complete physical examination and laboratory tests; Have a negative result for urinary opioids and must self report being at least 3 days opioid free. Participants may have a diagnosis of alcohol dependence so long as they do not have severe alcohol dependence that requires medical supervision for alcohol withdrawal. Exclusion Criteria: Current severe alcohol dependence that requires medical supervision for alcohol withdrawal; Current psychosis, dementia, mental retardation, or history of schizophrenia; Significant clinical abnormalities in hematology, chemistry, or urinalysis; Significant clinical cardiovascular, neurological, hepatic, renal, pulmonary, metabolic, endocrine, or gastrointestinal disorders; Female subjects who are pregnant or lactating, or female subjects of childbearing potential who are not using birth control (oral contraceptives, barrier (diaphragm or condom) plus spermicide, or levonorgestrel implant); (Pregnancy testing will be done on all females of child bearing age); and Current diagnosis of chronic pain disorder.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naltrexone Intervention<br>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: Vivitrol<br>* There are monthly injections of depot naltrexone for 3 months.<br>* Other names: depot naltrexone (380 mg);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary drug use outcome is illicit-positive urines during treatment and follow-up. |  | Participants will be followed for an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prescription opiates/medications, vivitrol, brain imaging