Trial Outcomes & Findings for An Alternative Dosing Schedule of Varenicline for Smoking Cessation (NCT NCT00835900)

NCT ID: NCT00835900

Last Updated: 2017-05-30

Results Overview

Change in cigarettes per day from Week 2 to Week 5

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: Change in cigarettes per day from Week 2 to Week 5
• Results posted on: 2017-05-30

Participant Flow

Participant milestones

Measure	Extended Run-In The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.	Standard Run-In The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks. Both groups received brief cognitive-behavioral counseling.
Overall Study STARTED	32	28
Overall Study COMPLETED	27	22
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Alternative Dosing Schedule of Varenicline for Smoking Cessation

Baseline characteristics by cohort

Measure	Extended Run-In n=32 Participants The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.	Standard Run-In n=28 Participants The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks. Both groups received brief cognitive-behavioral counseling.	Total n=60 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 10 • n=5 Participants	49 years STANDARD_DEVIATION 10 • n=7 Participants	48 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Nonwhite	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized White	29 Participants n=5 Participants	23 Participants n=7 Participants	52 Participants n=5 Participants
Baseline CPD	21 Cigarettes Per Day STANDARD_DEVIATION 5 • n=5 Participants	21 Cigarettes Per Day STANDARD_DEVIATION 5 • n=7 Participants	21 Cigarettes Per Day STANDARD_DEVIATION 5 • n=5 Participants

PRIMARY outcome

Timeframe: Change in cigarettes per day from Week 2 to Week 5

Population: ITT

Change in cigarettes per day from Week 2 to Week 5

Outcome measures

Measure	Extended Run-In n=32 Participants The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.	Standard Run-In n=28 Participants The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks. Both groups received brief cognitive-behavioral counseling.
Change in Smoking Behavior	-6.3 Change in Cigarettes Per Day Standard Error 0.9	-3.2 Change in Cigarettes Per Day Standard Error 0.7

SECONDARY outcome

Timeframe: 12 weeks after quit date.

Population: ITT

To parallel most clinical trials of varenicline, we focused on CO-verified (<11 parts per million) continuous abstinence (not even one puff) during the final 4 weeks of treatment (i.e., post-quit weeks 8 through 11). Participants lost to follow-up were coded as smokers.

Outcome measures

Measure	Extended Run-In n=32 Participants The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.	Standard Run-In n=28 Participants The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks. Both groups received brief cognitive-behavioral counseling.
Rates of Smoking Cessation.	17 Participants	11 Participants

Adverse Events

Extended Run-In

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Standard Run-In

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Extended Run-In n=32 participants at risk The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.	Standard Run-In n=28 participants at risk The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks. Both groups received brief cognitive-behavioral counseling.
Psychiatric disorders Irritability	0.00% 0/32	3.6% 1/28 • Number of events 1

Other adverse events

Measure	Extended Run-In n=32 participants at risk The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.	Standard Run-In n=28 participants at risk The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks. Both groups received brief cognitive-behavioral counseling.
Gastrointestinal disorders Nausea	56.2% 18/32 • Number of events 18	21.4% 6/28 • Number of events 6
Gastrointestinal disorders Constipation	25.0% 8/32 • Number of events 8	3.6% 1/28 • Number of events 1

Additional Information

Dr. Martin Mahoney

Roswell Park Cancer Institute

Phone: 7168452300

Email: martin.mahoney@roswellpark.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place