Improving Smoking Cessation Outcomes in Heavy Drinkers - 1

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00107575
First received: April 5, 2005
Last updated: May 24, 2010
Last verified: May 2010

April 5, 2005
May 24, 2010
August 2003
June 2007   (final data collection date for primary outcome measure)
  • Smoking Abstinence at 26 Weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt
  • Smoking Abstinence at 16 Weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    7 days of smoking abstinence confirmed biochemically at 16 weeks
  • Smoking Abstinence at 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    7 days of smoking abstinence confirmed biochemically at 8 weeks
  • Smoking Abstinence at 2 Weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    7 days of smoking abstinence confirmed biochemically at 2 weeks
Not Provided
Complete list of historical versions of study NCT00107575 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Improving Smoking Cessation Outcomes in Heavy Drinkers - 1
Improving Smoking Cessation Outcomes in Heavy Drinkers

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Tobacco Use Disorder
  • 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.
  • 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
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.
 
Completed
236
April 2008
June 2007   (final data collection date for primary outcome measure)

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).
Both
18 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00107575
NIDA-15534-1, R01-15534-1
No
Christopher Kahler, Brown University
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Christopher W Kahler, Ph.D. Brown University
National Institute on Drug Abuse (NIDA)
May 2010

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