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Improving Smoking Cessation Outcomes in Heavy Drinkers - 1

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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

Study Description
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Brief Summary:
To test the effectiveness of an smoking cessation treatment for smokers who also drink alcohol heavily.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Behavioral: Standard treatment plus brief alcohol intervention Other: Standard treatment (ST) Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Smoking Cessation Outcomes in Heavy Drinkers
Study Start Date : August 2003
Actual Primary Completion Date : June 2007
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard treatment (ST)
Standard smoking cessation treatment (ST)
 Other: Standard treatment (ST)
Behavioral smoking cessation counseling and nicotine patch.
Experimental: ST-BI
Standard treatment plus a brief alcohol intervention
 Behavioral: Standard treatment plus brief alcohol intervention
Standard smoking cessation treatment with nicotine patch plus a brief alcohol-focused intervention


Outcome Measures
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Primary Outcome Measures :
  1. Smoking Abstinence at 26 Weeks [ Time Frame: 26 weeks ]
    7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt

  2. Smoking Abstinence at 16 Weeks [ Time Frame: 16 weeks ]
    7 days of smoking abstinence confirmed biochemically at 16 weeks

  3. Smoking Abstinence at 8 Weeks [ Time Frame: 8 weeks ]
    7 days of smoking abstinence confirmed biochemically at 8 weeks

  4. Smoking Abstinence at 2 Weeks [ Time Frame: 2 weeks ]
    7 days of smoking abstinence confirmed biochemically at 2 weeks


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107575


Locations
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United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
Investigators
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Principal Investigator: Christopher W Kahler, Ph.D. Brown University
More Information
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Publications of Results:

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Responsible Party: Christopher W. Kahler, Professor, Brown University
ClinicalTrials.gov Identifier: NCT00107575    
Other Study ID Numbers: NIDA-15534-1
R01-15534-1
First Posted: April 6, 2005    Key Record Dates
Results First Posted: January 11, 2010
Last Update Posted: October 26, 2016
Last Verified: September 2016
Keywords provided by Christopher W. Kahler, Brown University:
tobacco
alcohol
Additional relevant MeSH terms:
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Tobacco Use Disorder
Alcoholic Intoxication
Substance-Related Disorders
 Chemically-Induced Disorders
Mental Disorders
Alcohol-Related Disorders