Depot Naltrexone Treatment of Opioid Dependent Parolees

Study Overview
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Brief Summary
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This is an investigation involving the use of a long-acting, injectable form (depot) of naltrexone as a treatment for persons who have a history of opioid dependence, with up to 40 on parole/probation and 20 non-parolees. The test is a pilot study of up to 60 subjects treated with 6 months of depot naltrexone plus Psychosocial Treatment .

Detailed Description
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This is a two phase study. Phase 1 is complete and phase 2 is not yet recruiting.

Official Title
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Depot Naltrexone Treatment of Opioid Dependent Parolees

Conditions
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Opioid Dependence

Intervention / Treatment
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* Drug: Depot Naltrexone


Participation Criteria
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Eligibility Criteria
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Inclusion/Exclusion Criteria. To be eligible to participate, participants must: sign an informed consent form; be between the ages of 18 and 55; have a diagnosis of opioid dependence according to DSM IVTR criteria; and be in good general health as determined by complete physical examination and laboratory tests; have been assigned to a probation/parole period of at least six months; (except those participants not on parole/probation, see note below); and 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. Participants with the following characteristics will be excluded from study participation: 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 levonorgestriel implant); subjects who have taken an opioid antagonist within the prior 6 months; and current diagnosis of chronic pain disorder.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single group<br>Depot Naltrexone | Drug: Depot Naltrexone<br>* 228mg of injectable naltrexone<br>* Other names: Depotrex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UDS results |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment completion |  | 6 months |