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Varenicline For Smokers In Recovery From Alcohol Dependence

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ClinicalTrials.gov Identifier: NCT01092702
Recruitment Status : Completed
First Posted : March 25, 2010
Results First Posted : November 30, 2010
Last Update Posted : April 19, 2011
Sponsor:
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tobacco Abstinence
Intervention Drug: Varenicline
Enrollment 32
Recruitment Details Recruitment began on 04/14/2008 and finished on 08/28/2008. Recruitment was in the general community of Rochester, Minnesota
Pre-assignment Details All potential participants consenting to enrollment completed a series of screening questionnaires. The questionnaires included demographic information, alcohol and smoking history, the the Center for Epidemiological Studies–Depressed Mood Scale, DAST-20, medical history and physical exam.
Arm/Group Title Varenicline
Hide Arm/Group Description Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
Period Title: Overall Study
Started 32
Completed 23
Not Completed 9
Reason Not Completed
Withdrawal by Subject             7
Lost to Follow-up             2
Arm/Group Title Varenicline
Hide Arm/Group Description Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
<=18 years
0
   0.0%
Between 18 and 65 years
32
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
42.9  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
10
  31.3%
Male
22
  68.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
cigarettes per day   [1] 
Mean (Standard Deviation)
Unit of measure:  Cigarettes per day
Number Analyzed 32 participants
20.3  (5.0)
[1]
Measure Description: Self reported average number of cigarettes smoked per day over the preceding 6 months prior to study enrollment.
Duration of alcohol recovery   [1] 
Median (Full Range)
Unit of measure:  Months
Number Analyzed 32 participants
29
(6 to 217)
[1]
Measure Description: Self reported number of months in recovery from alcohol dependence prior to study enrollment.
1.Primary Outcome
Title Biochemically Confirmed Abstinence From Smoking
Hide Description The primary endpoint of this trial is biochemically confirmed 7-day point prevalence smoking abstinence at the end of the medication phase (week 12). Self-reported abstinence from smoking (not even a puff) over the last 7-days will be considered biochemically confirmed by an expired air CO of <8 ppm. Subjects who discontinue the study or have a missed visit for any reason will be classified as smoking for that visit.
Time Frame 12 weeks from start of medication
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline
Hide Arm/Group Description:
Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
10
Time Frame Adverse Events were collected for the 12 weeks of study medication phase.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Varenicline
Hide Arm/Group Description Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
All-Cause Mortality
Varenicline
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline
Affected / at Risk (%)
Total   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Varenicline
Affected / at Risk (%)
Total   18/32 (56.25%) 
Gastrointestinal disorders   
Nausea *  9/32 (28.13%) 
other gastrointestinal *  3/32 (9.38%) 
General disorders   
Sleep Disturbance *  6/32 (18.75%) 
Abnormal Dreams *  5/32 (15.63%) 
Headache *  2/32 (6.25%) 
Psychiatric disorders   
Depression/Anxiety *  5/32 (15.63%) 
behavior Change *  2/32 (6.25%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: J Taylor Hays. MD
Organization: Mayo Clinic
Phone: 507-266-1944
Responsible Party: James Taylor Hays, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01092702     History of Changes
Other Study ID Numbers: 08-00672
First Submitted: March 19, 2010
First Posted: March 25, 2010
Results First Submitted: October 28, 2010
Results First Posted: November 30, 2010
Last Update Posted: April 19, 2011