Status:
COMPLETED
Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opiate Addiction
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
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 impro...
Detailed Description
This site serves as the coordinating center for five sites conducting the trial under the same IND and same protocol.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT00781898
Start Date
June 1 2008
End Date
August 1 2015
Last Update
October 23 2017
Active Locations (1)
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1
Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104