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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA011160 | U.S. NIH Grant/Contract | View source | |
| R01-11160-2 |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days.
Mon/Wed/Fri dosing with the 8 mg buprenorphine/naloxone tablet is as safe and effective as daily dosing and is preferred by patients to daily dosing. Multiple doses of the combination tablet (e.g. 16mg, 24mg) are well tolerated by patients. A 3 day schedule with take-outs is as effective as a 3-day schedule in which all medication is ingested at the clinic
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heroin Dependence | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Drug use | ||
| Retention | ||
| Compliance | ||
| Dosing schedule preferences | ||
| Analog rating scale for dosing schedule effects |
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Inclusion Criteria:
Individual must be currently dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.
Exclusion Criteria:
Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Amass, Ph.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Health Sciences Center | Denver | Colorado | 80206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Amass, L., Kamien, J.H., and Mikulich, S.K. Efficacy of and preference for 3-day vs daily dosing with the buprenorphine-naloxone combination tablet. presented to the 1998 Meeting of the College on Problems of Drug Dependence. Scottsdate, AZ (6/13-18). Presenting at CPDD 1998 |
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| ID | Term |
|---|---|
| D006556 | Heroin Dependence |
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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