Trial Outcomes & Findings for Hollings Cancer Center Varenicline Sampling Study (NCT NCT03742154)

NCT ID: NCT03742154

Last Updated: 2020-10-28

Results Overview

Percent of participants with any self-defined and any self-defined 24-hr quit attempt

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 99 participants
• Primary outcome timeframe: From study enrollment through end of three-month follow up
• Results posted on: 2020-10-28

Participant Flow

Participant milestones

Measure	Varenicline Group 50 participants will be enrolled in this group. They will receive a sample of varenicline to use for up to 4-weeks. They are receiving 40 - 0.5mg pills of varenicline, with instructions for titration. Varenicline 0.5 MG: varenicline comes in bottles of 56 - 0.5 mg pills	Control Group 49 participants will be enrolled in this group.
Overall Study STARTED	50	49
Overall Study COMPLETED	50	49
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hollings Cancer Center Varenicline Sampling Study

Baseline characteristics by cohort

Measure	Varenicline Group n=50 Participants 50 participants will be enrolled in this group. They will receive a sample of varenicline to use for up to 4-weeks. They are receiving 40 - 0.5mg pills of varenicline, with instructions for titration. Varenicline 0.5 MG: varenicline comes in bottles of 56 - 0.5 mg pills	Control Group n=49 Participants 50 participants will be enrolled in this group.	Total n=99 Participants Total of all reporting groups
Age, Continuous	43.0 Years STANDARD_DEVIATION 12.8 • n=5 Participants	40.4 Years STANDARD_DEVIATION 11.5 • n=7 Participants	41.7 Years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	35 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	14 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized White	40 Participants n=5 Participants	35 Participants n=7 Participants	75 Participants n=5 Participants
Race/Ethnicity, Customized Black	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Multiracial	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	49 participants n=7 Participants	99 participants n=5 Participants
Baseline Cigarettes Per Day (7 day avg)	18.4 cigarettes per day STANDARD_DEVIATION 7.2 • n=5 Participants	15.1 cigarettes per day STANDARD_DEVIATION 7.3 • n=7 Participants	16.8 cigarettes per day STANDARD_DEVIATION 7.3 • n=5 Participants
Cigarette Dependence (Heaviness of Smoking Index)	3.4 units on a scale STANDARD_DEVIATION 1.3 • n=5 Participants	2.8 units on a scale STANDARD_DEVIATION 1.5 • n=7 Participants	3.1 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants

PRIMARY outcome

Timeframe: From study enrollment through end of three-month follow up

Percent of participants with any self-defined and any self-defined 24-hr quit attempt

Outcome measures

Measure	Varenicline Group n=50 Participants 50 participants will be enrolled in this group. They will receive a sample of varenicline to use for up to 4-weeks. They are receiving 40 - 0.5mg pills of varenicline, with instructions for titration. Varenicline 0.5 MG: varenicline comes in bottles of 56 - 0.5 mg pills	Control Group n=49 Participants 50 participants will be enrolled in this group.
Quit Attempts Any self defined quit attempt	30 Participants	24 Participants
Quit Attempts Any 24 hour quit attempt	26 Participants	17 Participants

SECONDARY outcome

Timeframe: At the end of the three-month follow up

Percent of participants in the sampling group using varenicline at 3-month follow up assessment.

Outcome measures

Measure	Varenicline Group n=50 Participants 50 participants will be enrolled in this group. They will receive a sample of varenicline to use for up to 4-weeks. They are receiving 40 - 0.5mg pills of varenicline, with instructions for titration. Varenicline 0.5 MG: varenicline comes in bottles of 56 - 0.5 mg pills	Control Group 50 participants will be enrolled in this group.
Conversion of Varenicline Use Any use of varenicline	12 Participants	—
Conversion of Varenicline Use Daily use of varenicline	5 Participants	—

Adverse Events

Varenicline Group

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Varenicline Group n=50 participants at risk 50 participants will be enrolled in this group. They will receive a sample of varenicline to use for up to 4-weeks. They are receiving 40 - 0.5mg pills of varenicline, with instructions for titration. Varenicline 0.5 MG: varenicline comes in bottles of 56 - 0.5 mg pills	Control Group n=49 participants at risk 49 participants will be enrolled in this group.
General disorders Sleep Disturbance	32.0% 16/50 • 3 Months	6.1% 3/49 • 3 Months
General disorders Insomnia	10.0% 5/50 • 3 Months	6.1% 3/49 • 3 Months
Gastrointestinal disorders Nausea	22.0% 11/50 • 3 Months	2.0% 1/49 • 3 Months
General disorders Agitation	14.0% 7/50 • 3 Months	2.0% 1/49 • 3 Months
General disorders Depressed Mood	10.0% 5/50 • 3 Months	4.1% 2/49 • 3 Months
General disorders Headache	8.0% 4/50 • 3 Months	10.2% 5/49 • 3 Months
Gastrointestinal disorders Constipation	6.0% 3/50 • 3 Months	0.00% 0/49 • 3 Months
Gastrointestinal disorders Gas	6.0% 3/50 • 3 Months	0.00% 0/49 • 3 Months

Additional Information

Lisa Coles Program Coordinator

MUSC

Phone: 843-876-2291

Email: colesl@musc.edu

Results disclosure agreements

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