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Improving Smoking Cessation Outcomes in Heavy Drinkers - 1

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00107575
First Posted: April 6, 2005
Last Update Posted: October 26, 2016
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.
Information provided by (Responsible Party):
Christopher W. Kahler, Brown University
  Purpose
To test the effectiveness of an smoking cessation treatment for smokers who also drink alcohol heavily.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Christopher W. Kahler, Brown University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 236
Study Start Date: August 2003
Study Completion Date: April 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
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
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
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Christopher W Kahler, Ph.D. Brown University
  More Information

Publications:
Responsible Party: Christopher W. Kahler, Professor, Brown University
ClinicalTrials.gov Identifier: NCT00107575     History of Changes
Other Study ID Numbers: NIDA-15534-1
R01-15534-1
First Submitted: April 5, 2005
First Posted: April 6, 2005
Results First Submitted: November 30, 2009
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:
Tobacco Use Disorder
Alcoholic Intoxication
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol-Related Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs