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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Other: Standard treatment (ST); Behavioral: Standard treatment plus brief alcohol 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).

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Abstinence at 26 Weeks	7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt	26 weeks
Smoking Abstinence at 16 Weeks	7 days of smoking abstinence confirmed biochemically at 16 weeks	16 weeks
Smoking Abstinence at 8 Weeks	7 days of smoking abstinence confirmed biochemically at 8 weeks	8 weeks
Smoking Abstinence at 2 Weeks	7 days of smoking abstinence confirmed biochemically at 2 weeks	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Drinks Consumed Per Week Over a 2-week Period	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.	At 2, 8, 16, and 26-week follow-ups

Collaborators and Investigators

• Sponsor: Brown University
• Investigators: Principal Investigator: Christopher W Kahler, Ph.D., Brown University

Publications and helpful links

General Publications

• 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. doi: 10.1037/a0012717.

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: April 5, 2005
• First Submitted That Met QC Criteria: April 5, 2005
• First Posted (Estimate): April 6, 2005

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: September 20, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: alcohol; tobacco
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Tobacco Use Disorder; Alcoholic Intoxication
• Other Study ID Numbers: NIDA-15534-1; R01-15534-1