CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery (fMRI CURE)

University of Pennsylvania

Status and phase: Completed; Phase 2

Conditions: Prescription Opiate/Medication Dependence

Treatments: Drug: Vivitrol

Study type: Interventional

Funder types: Other

Identifiers

NCT01587196

813953

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Sign an informed consent form;
2. Be between the ages of 18 and 60;
3. Have a diagnosis of opioid dependence according to DSM IV-TR criteria (as assessed by the MINI);
4. Be in good general health as determined by complete physical examination and laboratory tests;
5. 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

1. Current severe alcohol dependence that requires medical supervision for alcohol withdrawal;
2. Current psychosis, dementia, mental retardation, or history of schizophrenia;
3. Significant clinical abnormalities in hematology, chemistry, or urinalysis;
4. Significant clinical cardiovascular, neurological, hepatic, renal, pulmonary, metabolic, endocrine, or gastrointestinal disorders;
5. 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
6. Current diagnosis of chronic pain disorder.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

Naltrexone Intervention

Experimental group

Description:

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.

Treatment:

Drug: Vivitrol