Trial Outcomes & Findings for Varenicline In-Patient Study (NCT NCT01413516)

NCT ID: NCT01413516

Last Updated: 2023-11-14

Results Overview

Self report of being quit for 7 continuous days at the time of the 4-week follow-up survey confirmed by saliva cotinine or urine anabasine verification.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: 4 weeks after beginning study
• Results posted on: 2023-11-14

Participant Flow

Participant milestones

Measure	Control: Sugar Pill Without Any Active Medication Smoking counseling, Placebo: Placebo comparator Interventions: * Behavior: smoking counseling * Drug: placebo (sugar pill without any active medication) Smoking counseling: Counseling sessions provided by a trained smoking counselor during 1st day of study along with 28 day supply of placebo Placebo: Sugar pill without any active medication	Experimental: Varenicline Smoking counseling, Varenicline: Experimental Interventions: * Behavioral: smoking counseling * Drug: varenicline Smoking counseling: Counseling sessions provided by trained smoking counselor during 1st day of study along with 28 day supply of varenicline Varenicline: Varenicline (an approved medication for smoking cessation)
Overall Study STARTED	8	9
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Varenicline In-Patient Study

Baseline characteristics by cohort

Measure	Control: Sugar Pill Without Any Active Medication n=8 Participants Smoking counseling, Placebo: Placebo comparator Interventions: * Behavior: smoking counseling * Drug: placebo (sugar pill without any active medication) Smoking counseling: Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study Placebo: Sugar pill without any active medication	Experimental: Varenicline n=9 Participants Smoking counseling, Varenicline: Experimental Interventions: * Behavioral: smoking counseling * Drug: varenicline Smoking counseling: Counseling sessions provided by trained smoking counselor along with varenicline Varenicline: Varenicline (an approved medication for smoking cessation)	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	52 years STANDARD_DEVIATION 14 • n=5 Participants	48 years STANDARD_DEVIATION 13 • n=7 Participants	50 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks after beginning study

Self report of being quit for 7 continuous days at the time of the 4-week follow-up survey confirmed by saliva cotinine or urine anabasine verification.

Outcome measures

Measure	Sugar Pill Without Any Active Medication n=8 Participants Smoking counseling, Placebo: Placebo comparator Interventions: * Behavior: smoking counseling * Drug: placebo (sugar pill without any active medication) Smoking counseling: Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study Placebo: Sugar pill without any active medication	Experimental: Varenicline n=9 Participants Smoking counseling, Varenicline: Experimental Interventions: * Behavioral: smoking counseling * Drug: varenicline Smoking counseling: Counseling sessions provided by trained smoking counselor along with varenicline Varenicline: Varenicline (an approved medication for smoking cessation)
7 Day Point Prevalence Abstinence From All Forms of Tobacco	2 participants	2 participants

Adverse Events

Control: Sugar Pill Without Any Active Medication

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental: Varenicline

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control: Sugar Pill Without Any Active Medication n=8 participants at risk Smoking counseling, Placebo: Placebo comparator Interventions: * Behavior: smoking counseling * Drug: placebo (sugar pill without any active medication) Smoking counseling: Counseling sessions provided by a trained smoking counselor during 1st day of study along with 28 day supply of placebo Placebo: Sugar pill without any active medication	Experimental: Varenicline n=9 participants at risk Smoking counseling, Varenicline: Experimental Interventions: * Behavioral: smoking counseling * Drug: varenicline Smoking counseling: Counseling sessions provided by trained smoking counselor during 1st day of study along with 28 day supply of varenicline Varenicline: Varenicline (an approved medication for smoking cessation)
Musculoskeletal and connective tissue disorders Leg amputation	0.00% 0/8 assessed by self-report at every time point	11.1% 1/9 • Number of events 1 assessed by self-report at every time point
Renal and urinary disorders Renal disorder	0.00% 0/8 assessed by self-report at every time point	11.1% 1/9 • Number of events 1 assessed by self-report at every time point

Other adverse events

Adverse event data not reported

Additional Information

Judith Prochaska

Stanford University

Phone: 6507243608

Email: jodi.prochaska@stanford.edu

Results disclosure agreements

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