Status:
COMPLETED
Improving Smoking Cessation Outcomes in Heavy Drinkers - 1
Lead Sponsor:
Brown University
Conditions:
Tobacco Use Disorder
Eligibility:
All Genders
18-95 years
Phase:
PHASE2
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 interve...
Eligibility Criteria
Inclusion
- be at least 18 years of age
- have smoked cigarettes regularly for at least one year
- currently smoke at least 10 cigarettes a day
- currently be using no other tobacco products or nicotine replacement therapy
- 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
- meet full DSM-IV criteria for alcohol dependence in the past 12 months
- meet criteria for other current psychoactive substance abuse or dependence (excluding nicotine dependence and alcohol abuse) in the past 12 months \[this would also exclude individuals with lifetime substance dependence who continue to have some abuse/dependence symptoms in the past 12 months\]
- meet criteria for current dysthymia, major depression, or manic episode \[past month\]
- are currently psychotic \[past 12 months\] or suicidal \[suicidal ideation or intent in the past month\]
- 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)
- 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).
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT00107575
Start Date
August 1 2003
End Date
April 1 2008
Last Update
October 26 2016
Active Locations (1)
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1
Brown University
Providence, Rhode Island, United States, 02912