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Improving Smoking Cessation Outcomes in Heavy Drinkers - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00107575
Recruitment Status : Completed
First Posted : April 6, 2005
Results First Posted : January 11, 2010
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Christopher W. Kahler, Brown University

Tracking Information
First Submitted Date  ICMJE April 5, 2005
First Posted Date  ICMJE April 6, 2005
Results First Submitted Date  ICMJE November 30, 2009
Results First Posted Date  ICMJE January 11, 2010
Last Update Posted Date October 26, 2016
Study Start Date  ICMJE August 2003
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2010)
  • Smoking Abstinence at 26 Weeks [ Time Frame: 26 weeks ]
    7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt
  • Smoking Abstinence at 16 Weeks [ Time Frame: 16 weeks ]
    7 days of smoking abstinence confirmed biochemically at 16 weeks
  • Smoking Abstinence at 8 Weeks [ Time Frame: 8 weeks ]
    7 days of smoking abstinence confirmed biochemically at 8 weeks
  • Smoking Abstinence at 2 Weeks [ Time Frame: 2 weeks ]
    7 days of smoking abstinence confirmed biochemically at 2 weeks
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2010)
Alcohol Drinks Consumed Per Week Over a 2-week Period [ Time Frame: At 2, 8, 16, and 26-week follow-ups ]
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tobacco Use Disorder
Intervention  ICMJE
  • Behavioral: Standard treatment plus brief alcohol intervention
    Standard smoking cessation treatment with nicotine patch plus a brief alcohol-focused intervention
  • Other: Standard treatment (ST)
    Behavioral smoking cessation counseling and nicotine patch.
Study Arms  ICMJE
  • Active Comparator: Standard treatment (ST)
    Standard smoking cessation treatment (ST)
    Intervention: Other: Standard treatment (ST)
  • Experimental: ST-BI
    Standard treatment plus a brief alcohol intervention
    Intervention: Behavioral: Standard treatment plus brief alcohol intervention
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. doi: 10.1037/a0012717.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2010)
236
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
250
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. be at least 18 years of age
  2. have smoked cigarettes regularly for at least one year
  3. currently smoke at least 10 cigarettes a day
  4. currently be using no other tobacco products or nicotine replacement therapy
  5. currently drink heavily according to self-report (>14 drinks per week or >5 drinks per occasion at least once per month over the last 12 months for men; >7 drinks per week or >4 drinks per occasion at least once per month over the past 12 months for women)

Exclusion Criteria:

  1. meet full DSM-IV criteria for alcohol dependence in the past 12 months
  2. meet criteria for other current psychoactive substance abuse or dependence (excluding nicotine dependence and alcohol abuse) in the past 12 months [this would also exclude individuals with lifetime substance dependence who continue to have some abuse/dependence symptoms in the past 12 months]
  3. meet criteria for current dysthymia, major depression, or manic episode [past month]
  4. are currently psychotic [past 12 months] or suicidal [suicidal ideation or intent in the past month]
  5. have an unstable medical condition that would suggest caution in the use of the nicotine patch (e.g., unstable angina pectoris, arrhythmia, recent congestive heart failure)
  6. are currently pregnant or lactating or intend to become pregnant. We also will exclude participants who are not alcohol dependent but who have characteristics that might make supervised alcohol detoxification necessary (e.g., morning drinking to avoid withdrawal, daily drinking of >12 drinks, recent withdrawal symptoms, history of severe withdrawal symptoms such as hallucinations, seizures, or delirium tremens).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00107575
Other Study ID Numbers  ICMJE NIDA-15534-1
R01-15534-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christopher W. Kahler, Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher W Kahler, Ph.D. Brown University
PRS Account Brown University
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP