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

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

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.

• 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.