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
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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 Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, 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 National Institute on Drug Abuse (NIDA):
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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.
| 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| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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).
Contacts and Locations More Information
Publications:
| Responsible Party: | Christopher Kahler, Brown University |
| ClinicalTrials.gov Identifier: | NCT00107575 History of Changes |
| Other Study ID Numbers: | NIDA-15534-1, R01-15534-1 |
| Study First Received: | April 5, 2005 |
| Results First Received: | November 30, 2009 |
| Last Updated: | May 24, 2010 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Alcoholic Intoxication Tobacco Use Disorder Alcohol-Related Disorders Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013