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Effectiveness of Varenicline: Testing Individual Differences (Varenicline)

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ClinicalTrials.gov Identifier: NCT01228175
Recruitment Status : Completed
First Posted : October 26, 2010
Results First Posted : November 4, 2016
Last Update Posted : May 9, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kent Hutchison, Ph.D., The Mind Research Network

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Smoking Addiction
Interventions Drug: Placebo
Drug: Varenicline
Enrollment 218
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline Microcrystal Cellulose
Hide Arm/Group Description

Varenicline

Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily

Microcrystal cellulose placebo

Placebo: 25mg look alike riboflavin tablets to match active study medication.

Period Title: Overall Study
Started 119 99
Completed 53 46
Not Completed 66 53
Reason Not Completed
Lost to Follow-up             64             50
Withdrawal by Subject             1             2
Physician Decision             1             1
Arm/Group Title Varenicline Microcrystal Cellulose Total
Hide Arm/Group Description

Varenicline

Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily

Microcrystal cellulose placebo

Placebo: 25mg look alike riboflavin tablets to match active study medication.

Total of all reporting groups
Overall Number of Baseline Participants 119 99 218
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 99 participants 218 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
119
 100.0%
99
 100.0%
218
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 99 participants 218 participants
Female
81
  68.1%
64
  64.6%
145
  66.5%
Male
38
  31.9%
35
  35.4%
73
  33.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 119 participants 99 participants 218 participants
119
 100.0%
99
 100.0%
218
 100.0%
1.Primary Outcome
Title Cigarettes Per Smoking Day
Hide Description The number of cigarettes smoked were assessed only on a "smoking day", i.e., when a participant smoked at least 1 cigarette. Data was recorded each day for up to 36 weeks.
Time Frame up to 36 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline Microcrystal Cellulose
Hide Arm/Group Description:

Varenicline

Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily

Microcrystal cellulose placebo

Placebo: 25mg look alike riboflavin tablets to match active study medication.

Overall Number of Participants Analyzed 53 46
Mean (Standard Deviation)
Unit of Measure: Cigarettes per smoking day
4.9256  (5.62357) 8.4989  (8.53172)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Varenicline Microcrystal Cellulose
Hide Arm/Group Description

Varenicline

Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily

Microcrystal cellulose placebo

Placebo: 25mg look alike riboflavin tablets to match active study medication.

All-Cause Mortality
Varenicline Microcrystal Cellulose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline Microcrystal Cellulose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/119 (0.00%)   0/99 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Varenicline Microcrystal Cellulose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/119 (0.00%)   0/99 (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
Name/Title: Dr. Kent Hutchison
Organization: University of Colorado Boulder
Phone: 303-492-8163
Responsible Party: Kent Hutchison, Ph.D., The Mind Research Network
ClinicalTrials.gov Identifier: NCT01228175     History of Changes
Other Study ID Numbers: R01DA025074 ( U.S. NIH Grant/Contract )
R01DA025074 ( U.S. NIH Grant/Contract )
First Submitted: September 8, 2010
First Posted: October 26, 2010
Results First Submitted: September 16, 2016
Results First Posted: November 4, 2016
Last Update Posted: May 9, 2018