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Improving Smoking Cessation Outcomes in Heavy Drinkers - 1

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Standard treatment plus brief alcohol intervention
Standard treatment (ST)
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring tobacco, alcohol

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Brown University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard treatment (ST)

ST-BI

Arm Description

Standard smoking cessation treatment (ST)

Standard treatment plus a brief alcohol intervention

Outcomes

Primary Outcome Measures

Smoking Abstinence at 26 Weeks
7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt
Smoking Abstinence at 16 Weeks
7 days of smoking abstinence confirmed biochemically at 16 weeks
Smoking Abstinence at 8 Weeks
7 days of smoking abstinence confirmed biochemically at 8 weeks
Smoking Abstinence at 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
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.

Full Information

First Posted
April 5, 2005
Last Updated
September 20, 2016
Sponsor
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT00107575
Brief Title
Improving Smoking Cessation Outcomes in Heavy Drinkers - 1
Official Title
Improving Smoking Cessation Outcomes in Heavy Drinkers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
tobacco, alcohol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment (ST)
Arm Type
Active Comparator
Arm Description
Standard smoking cessation treatment (ST)
Arm Title
ST-BI
Arm Type
Experimental
Arm Description
Standard treatment plus a brief alcohol intervention
Intervention Type
Behavioral
Intervention Name(s)
Standard treatment plus brief alcohol intervention
Intervention Description
Standard smoking cessation treatment with nicotine patch plus a brief alcohol-focused intervention
Intervention Type
Other
Intervention Name(s)
Standard treatment (ST)
Intervention Description
Behavioral smoking cessation counseling and nicotine patch.
Primary Outcome Measure Information:
Title
Smoking Abstinence at 26 Weeks
Description
7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt
Time Frame
26 weeks
Title
Smoking Abstinence at 16 Weeks
Description
7 days of smoking abstinence confirmed biochemically at 16 weeks
Time Frame
16 weeks
Title
Smoking Abstinence at 8 Weeks
Description
7 days of smoking abstinence confirmed biochemically at 8 weeks
Time Frame
8 weeks
Title
Smoking Abstinence at 2 Weeks
Description
7 days of smoking abstinence confirmed biochemically at 2 weeks
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Alcohol Drinks Consumed Per Week Over a 2-week Period
Description
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.
Time Frame
At 2, 8, 16, and 26-week follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher W Kahler, Ph.D.
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18837602
Citation
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.
Results Reference
result

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Improving Smoking Cessation Outcomes in Heavy Drinkers - 1

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