Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Smoking Cessation Outcomes in Heavy Drinkers - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00107575
Recruitment Status : Completed
First Posted : April 6, 2005
Results First Posted : January 11, 2010
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Christopher W. Kahler, Brown University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Tobacco Use Disorder
Interventions Behavioral: Standard treatment plus brief alcohol intervention
Other: Standard treatment (ST)
Enrollment 236
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Treatment Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)
Hide Arm/Group Description Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
Period Title: Overall Study
Started 119 117
Completed 108 107
Not Completed 11 10
Arm/Group Title Standard Treatment Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) Total
Hide Arm/Group Description Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention Total of all reporting groups
Overall Number of Baseline Participants 119 117 236
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 117 participants 236 participants
<=18 years
2
   1.7%
0
   0.0%
2
   0.8%
Between 18 and 65 years
113
  95.0%
112
  95.7%
225
  95.3%
>=65 years
4
   3.4%
5
   4.3%
9
   3.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 119 participants 117 participants 236 participants
40.6  (12.1) 42.3  (11.8) 41.5  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 117 participants 236 participants
Female
53
  44.5%
53
  45.3%
106
  44.9%
Male
66
  55.5%
64
  54.7%
130
  55.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 119 participants 117 participants 236 participants
119 117 236
1.Primary Outcome
Title Smoking Abstinence at 26 Weeks
Hide Description 7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For analyses of smoking outcomes, missing data were considered smoking. However, at 26 weeks, 2 participants in ST-BI had died and therefore their data was left as missing for this period.
Arm/Group Title Standard Treatment Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)
Hide Arm/Group Description:
Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
Overall Number of Participants Analyzed 119 115
Measure Type: Number
Unit of Measure: participants
21 22
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Treatment, Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Smoking Abstinence at 16 Weeks
Hide Description 7 days of smoking abstinence confirmed biochemically at 16 weeks
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Treatment Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)
Hide Arm/Group Description:
Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
Overall Number of Participants Analyzed 119 117
Measure Type: Number
Unit of Measure: Participants
21 21
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Treatment, Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .18
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Primary Outcome
Title Smoking Abstinence at 8 Weeks
Hide Description 7 days of smoking abstinence confirmed biochemically at 8 weeks
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Treatment Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)
Hide Arm/Group Description:
Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
Overall Number of Participants Analyzed 119 117
Measure Type: Number
Unit of Measure: Participants
37 46
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Treatment, Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .95
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Primary Outcome
Title Smoking Abstinence at 2 Weeks
Hide Description 7 days of smoking abstinence confirmed biochemically at 2 weeks
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Treatment Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)
Hide Arm/Group Description:
Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
Overall Number of Participants Analyzed 119 117
Measure Type: Number
Unit of Measure: Participants
54 67
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Treatment, Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .76
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Alcohol Drinks Consumed Per Week Over a 2-week Period
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of participants who provided at least some valid data on the Timeline Followback Interview
Arm/Group Title Standard Treatment Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)
Hide Arm/Group Description:
Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
Overall Number of Participants Analyzed 106 110
Mean (Standard Deviation)
Unit of Measure: drinks
Drinks per week: Weeks 1-2 9.8  (10.0) 8.2  (9.9)
Drinks per week: Weeks 3-4 10.3  (10.4) 8.4  (10.8)
Drinks per week: Weeks 5-6 10.3  (10.9) 9.1  (11.1)
Drinks per week: Weeks 7-8 10.7  (10.7) 9.6  (11.2)
Drinks per week: Weeks 9-10 10.1  (9.7) 9.1  (9.8)
Drinks per week: Weeks 11-12 9.5  (9.8) 9.2  (10.3)
Drinks per week: Weeks 13-14 10.5  (11.2) 8.6  (9.1)
Drinks per week: Weeks 15-16 10.6  (11.0) 9.2  (9.6)
Drinks per week: Weeks 17-18 10.9  (10.3) 9.0  (10.3)
Drinks per week: Weeks 19-20 10.8  (10.3) 9.8  (11.8)
Drinks per week: Weeks 21-22 10.1  (9.3) 9.1  (11.2)
Drinks per week: Weeks 23-24 9.8  (8.6) 9.1  (12.0)
Drinks per week: Weeks 25-26 10.9  (9.9) 10.0  (13.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Treatment, Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .027
Comments a priori p-value was p < .05
Method generalized estimating equations
Comments Negative binomial model controlling for sex, motivation to change drinking, and baseline drinking
Method of Estimation Estimation Parameter expected count ratio
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.67 to 0.98
Estimation Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Treatment Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)
Hide Arm/Group Description Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
All-Cause Mortality
Standard Treatment Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Standard Treatment Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/119 (0.00%)   2/117 (1.71%) 
General disorders     
Death  0/119 (0.00%)  2/117 (1.71%) 
Respiratory, thoracic and mediastinal disorders     
Lung Cancer  0/119 (0.00%)  1/117 (0.85%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Treatment Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/119 (0.00%)   0/117 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher Kahler
Organization: Brown University
Phone: (401) 863-6651
EMail: Christopher_Kahler@brown.edu
Layout table for additonal information
Responsible Party: Christopher W. Kahler, Brown University
ClinicalTrials.gov Identifier: NCT00107575    
Other Study ID Numbers: NIDA-15534-1
R01-15534-1
First Submitted: April 5, 2005
First Posted: April 6, 2005
Results First Submitted: November 30, 2009
Results First Posted: January 11, 2010
Last Update Posted: October 26, 2016