Improving Smoking Cessation Outcomes in Heavy Drinkers - 1

Phase 2

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Behavioral: Standard treatment plus brief alcohol intervention; Other: Standard treatment (ST)

• Registration Number: NCT00107575
• Lead Sponsor: Brown University

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 Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-04-05
• Study First Submitted QC: 2005-04-05
• Study First Posted: 2005-04-06
• Primary Completion: 2007-06
• Study Completion: 2008-04
• Results First Submitted: 2009-11-30
• Results First Submitted QC: 2010-01-07
• Results First Posted: 2010-01-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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)

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
ST-BI	Standard treatment plus brief alcohol intervention	Standard treatment plus a brief alcohol intervention
Standard treatment (ST)	Standard treatment (ST)	Standard smoking cessation treatment (ST)

Primary Outcome Measures

Name	Time	Method
Smoking Abstinence at 26 Weeks	26 weeks	7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt
Smoking Abstinence at 16 Weeks	16 weeks	7 days of smoking abstinence confirmed biochemically at 16 weeks
Smoking Abstinence at 8 Weeks	8 weeks	7 days of smoking abstinence confirmed biochemically at 8 weeks
Smoking Abstinence at 2 Weeks	2 weeks	7 days of smoking abstinence confirmed biochemically at 2 weeks

Secondary Outcome Measures

Name	Time	Method
Alcohol Drinks Consumed Per Week Over a 2-week Period	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.

Trial Locations

Locations (1)

Brown University; 🇺🇸 Providence, Rhode Island, United States