Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site

Study Overview
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Brief Summary
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The aim of this project is to conduct a multi-site effectiveness study to determine whether the addition of a monthly injection of depot naltrexone to treatment as usual (TAU) will significantly improve outcome in parolees and probationers with a history of opioid addiction compared to TAU alone. Participants will be randomized to either treatment as usual in community programs or monthly injections of depot naltrexone for six months with treatment as usual in community programs. The effectiveness of depot naltrexone has never been studied in opioid dependent parolees. all parolee subjects will be evaluated at baseline, while in treatment, and at 6, 12 and 18 month post entry time points. The primary study outcomes are retention in treatment, drug use, re-arrests, psychosocial and medical/psychiatric functioning, and economic costs and benefit costs of naltrexone.

Detailed Description
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This site serves as the coordinating center for five sites conducting the trial under the same IND and same protocol.

Official Title
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Prevention of Relapse to Opioid Addiction Using Depot Naltrexone

Conditions
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Opiate Addiction

Intervention / Treatment
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* Drug: Depot naltrexone
* Other: Treatment as Usual (TAU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be between the ages of 18 and 60; Have dx of opioid dependence according to DSM-IV criteria be in good general health as determined by complete physical and laboratory tests; Under some form of criminal justice supervision for at least 12 months; Have a negative result for urinary opioids and no sign of opiate withdrawal after IV (or IM) injection of 0.8 mg of naloxone; and Express a goal of opiate free treatment rather than agonist maintenance Exclusion Criteria: Current drug or alcohol dependence that requires medical supervision; untreated psychiatric disorders that might make participation hazardous (e.g. untreated psychosis, bipolar disorder with mania, significant suicide risk). Adequately treated psychiatric disorders and appropriate psychotropic medications would be allowed. 3. Active medical illness that might make participation hazardous (e.g., untreated hypertension, hepatitis with AST or ALT >3 times upper limit of normal, unstable diabetes or heart disease). Adequately treated medical conditions are acceptable; 4. 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); 5. Liver failure or liver function test levels greater than three times normal; 6. History of allergic reaction to naltrexone; 7. History of a drug overdose in the past 3 years; and 8. Current diagnosis of chronic pain disorder for which opioids are prescribed for pain relief.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Depot Naltrexone<br> | Drug: Depot naltrexone<br>* Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.<br>|
| Placebo Comparator: Placebo<br> | Other: Treatment as Usual (TAU)<br>* Treatment as Usual (TAU) community treatment provided to the participant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse | A relapse event was defined as 10 or more days of opioid use in a 28-day (4-week) period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depot naltrexone, Parolees, Opioid addiction prevention, Medication Treatment Alternatives, Prevention of Relapse to Opioid Addiction