Improving Smoking Cessation Outcomes in Heavy Drinkers - 1
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Tracking Information | |||||
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First Received Date ICMJE | April 5, 2005 | ||||
Last Updated Date | May 24, 2010 | ||||
Start Date ICMJE | August 2003 | ||||
Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00107575 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Alcohol Drinks Consumed Per Week Over a 2-week Period [ Time Frame: At 2, 8, 16, and 26-week follow-ups ] [ Designated as safety issue: No ] 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. |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Improving Smoking Cessation Outcomes in Heavy Drinkers - 1 | ||||
Official Title ICMJE | Improving Smoking Cessation Outcomes in Heavy Drinkers | ||||
Brief Summary | To test the effectiveness of an smoking cessation treatment for smokers who also drink alcohol heavily. |
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Detailed Description | 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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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Tobacco Use Disorder | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 236 | ||||
Completion Date | April 2008 | ||||
Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 95 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00107575 | ||||
Other Study ID Numbers ICMJE | NIDA-15534-1, R01-15534-1 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Christopher Kahler, Brown University | ||||
Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | National Institute on Drug Abuse (NIDA) | ||||
Verification Date | May 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |