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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA011210 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The purpose of this study is to determine the effectiveness of naltrexone (Revia) or matched placebo combined with nicotine patch (Nicotrol) or placebo patch using a 2x2 design in reducing drinking and smoking in patients with both nicotine and alcohol dependence.
Eligible individuals will be randomly assigned to a 12-week trial of a fixed daily dose of either naltrexone (Revia) and nicotine replacement patch or placebos. All individuals will receive weekly coping skills and smoking-cessation behavioral therapy. Followup interviews will be conducted 3 and 6 months after treatment to determine smoking and drinking status and persistence of any dependence symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone Tablet and Nicotine Patch | Experimental |
| |
| Naltrexone Tablet and Placebo Patch | Active Comparator |
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| Placebo Tablet and Nicotine Patch | Active Comparator |
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| Placebo Tablet and Placebo Patch | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone Tablet and Nicotine Patch | Drug |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Mason, PhD | University of Miam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, University of Miami School of Medicine | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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Double blind tablet and patch active study medications, and matched tablet and patch placebos
| Naltrexone Tablet and Placebo Patch |
| Drug |
|
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| Placebo Tablet and Nicotine Patch | Drug |
|
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| Placebo Tablet and Placebo Patch | Drug |
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| D001519 | Behavior |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |