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| ID | Type | Description | Link |
|---|---|---|---|
| R01-15534-1 |
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To test the effectiveness of an smoking cessation treatment for smokers who also drink alcohol heavily.
Heavy alcohol use frequently co-occurs with cigarette smoking and may impede smoking cessation. This clinical trial examined whether smoking cessation treatment that incorporates brief alcohol intervention can improve smoking cessation outcomes (7-day verified point prevalence abstinence) and reduce drinks consumed per week. Heavy drinkers seeking smoking cessation treatment were assigned by urn randomization to receive, along with 8-weeks of nicotine replacement therapy, either a 4-session standard smoking cessation treatment (ST, n = 119) or standard treatment of equal intensity that incorporated brief alcohol intervention (ST-BI, n = 117).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment (ST) | Active Comparator | Standard smoking cessation treatment (ST) |
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| ST-BI | Experimental | Standard treatment plus a brief alcohol intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard treatment plus brief alcohol intervention | Behavioral | Standard smoking cessation treatment with nicotine patch plus a brief alcohol-focused intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Abstinence at 26 Weeks | 7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt | 26 weeks |
| Smoking Abstinence at 16 Weeks | 7 days of smoking abstinence confirmed biochemically at 16 weeks | 16 weeks |
| Smoking Abstinence at 8 Weeks | 7 days of smoking abstinence confirmed biochemically at 8 weeks | 8 weeks |
| Smoking Abstinence at 2 Weeks | 7 days of smoking abstinence confirmed biochemically at 2 weeks | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Drinks Consumed Per Week Over a 2-week Period | Average number of standard alcoholic drinks consumed per week over each 2-week period across the 26 weeks of follow-up as assessed by the Timeline Followback Interview. Standard alcoholic drink is defined as 12 oz of beer, 5 oz of wine, or 1.5 ounces of liquor. | At 2, 8, 16, and 26-week follow-ups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher W Kahler, Ph.D. | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02912 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18837602 | Result | Kahler CW, Metrik J, LaChance HR, Ramsey SE, Abrams DB, Monti PM, Brown RA. Addressing heavy drinking in smoking cessation treatment: a randomized clinical trial. J Consult Clin Psychol. 2008 Oct;76(5):852-62. doi: 10.1037/a0012717. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Treatment | Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch |
| FG001 | Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Treatment | Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch |
| BG001 | Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Smoking Abstinence at 26 Weeks | 7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt | For analyses of smoking outcomes, missing data were considered smoking. However, at 26 weeks, 2 participants in ST-BI had died and therefore their data was left as missing for this period. | Posted | Number | participants | 26 weeks |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Treatment | Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Kahler | Brown University | (401) 863-6651 | Christopher_Kahler@brown.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D008722 | Methods |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008919 | Investigative Techniques |
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| Standard treatment (ST) | Other | Behavioral smoking cessation counseling and nicotine patch. |
|
Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Alcohol Drinks Consumed Per Week Over a 2-week Period | Average number of standard alcoholic drinks consumed per week over each 2-week period across the 26 weeks of follow-up as assessed by the Timeline Followback Interview. Standard alcoholic drink is defined as 12 oz of beer, 5 oz of wine, or 1.5 ounces of liquor. | The number of participants analyzed reflects the number of participants who provided at least some valid data on the Timeline Followback Interview | Posted | Mean | Standard Deviation | drinks | At 2, 8, 16, and 26-week follow-ups |
|
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| Primary | Smoking Abstinence at 16 Weeks | 7 days of smoking abstinence confirmed biochemically at 16 weeks | Posted | Number | Participants | 16 weeks |
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| Primary | Smoking Abstinence at 8 Weeks | 7 days of smoking abstinence confirmed biochemically at 8 weeks | Posted | Number | Participants | 8 weeks |
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| Primary | Smoking Abstinence at 2 Weeks | 7 days of smoking abstinence confirmed biochemically at 2 weeks | Posted | Number | Participants | 2 weeks |
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| 0 |
| 119 |
| 0 |
| 119 |
| EG001 | Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention | 2 | 117 | 0 | 117 |
| Lung Cancer | Respiratory, thoracic and mediastinal disorders |
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| Drinks per week: Weeks 5-6 |
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| Drinks per week: Weeks 7-8 |
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| Drinks per week: Weeks 9-10 |
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| Drinks per week: Weeks 11-12 |
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| Drinks per week: Weeks 13-14 |
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| Drinks per week: Weeks 15-16 |
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| Drinks per week: Weeks 17-18 |
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| Drinks per week: Weeks 19-20 |
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| Drinks per week: Weeks 21-22 |
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| Drinks per week: Weeks 23-24 |
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| Drinks per week: Weeks 25-26 |
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