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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA033670 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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To address the question of the comparison of two courses of Vivitrol with differing lengths in 130 HIV negative, consenting, opioid addicted patients who have completed inpatient treatment. Participants will be randomized under double blind conditions to a 24 or 48-week course of pharmacotherapy, along with bi-weekly drug counselling, over 48 weeks, with follow-ups at weeks 60 and 72. The 24-week cohort will receive Vivitrol placebo injections in weeks 24 to 48.
1.2.1 Primary and Secondary Outcome Measures
Primary outcomes are:
1) Opiate positive urine tests; 2) HIV injecting risk.
Secondary outcomes are:
1) Time to relapse; 2) HIV sex risk; 3) Proportion of appointments kept; 6) Psychiatric symptoms; 7) Opioid craving; 8) Self-reported drug use; 9) Money spent for drugs; 10) Employment; 11) Arrests; 12) Overall adjustment; 12) Adverse events.
Hypotheses are that:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| injectable naltrexone | Active Comparator | One dose of injectable extended release naltrexone (Vivitrol), 380mg dosage, given every four weeks in a 48-week trial. |
|
| placebo injection for naltrexone | Placebo Comparator | placebo comparator injection starting at week 24 in a 48-week trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injectable naltrexone | Drug | Vivitrol is an extended-release, microsphere formulation of naltrexone designed to be administered by intramuscular (IM) gluteal injection every 4 weeks or once a month. After IM injection, the naltrexone plasma concentration time profile is characterized by a transient initial peak, which occurs approximately 2 hours after injection, followed by a second peak observed approximately 2 - 3 days later. Beginning approximately 14 days after dosing, concentrations slowly decline, with measurable levels for greater than 1 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Opiate positive urine tests | Reduction in drug use as seen by the primary urine outcomes will significantly favor the 48-week Vivitrol condition | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| HIV sex risk | Participants will show significant HIV sex risk behaviors in the 48-week vivitrol condition. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | No increase in known adverse events for the vivitrol arm as seen in other studies. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George E Woody, MD | University of Pennsylvania | Principal Investigator |
| Tatiana Klimenko, MD, PhD | Federal Medical Research Center for Psychiatry and Narcology (FMRC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Medical Research Center for Psychiatry and Narcology (FMRC) | Moscow | 119002 | Russia |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000624616 | vivitrol |
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| placebo comparator | Drug | this placebo has no specific pharmacological activity |
|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |