Trial Outcomes & Findings for Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity (NCT NCT00664755)

NCT ID: NCT00664755

Last Updated: 2018-05-24

Results Overview

Carbon monoxide (≤10 parts per million) verified abstinence during the last two weeks of treatment

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 140 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2018-05-24

Participant Flow

Participant milestones

Measure	Varenicline Participant randomized to receive active varenicline and placebo transdermal nicotine patch. varenicline: Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID Varenicline is taken for a duration of 4 weeks in this study.	Transdermal Nicotine Patch Participant randomized to receive active transdermal nicotine patch and placebo varenicline. transdermal nicotine patch: Weeks 0-3: 21mg patch Transdermal nicotine patch is used for a duration of 3 weeks in this study.
Overall Study STARTED	67	73
Overall Study COMPLETED	67	73
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

Baseline characteristics by cohort

Measure	Varenicline n=67 Participants Participant randomized to receive active varenicline and placebo transdermal nicotine patch. varenicline: Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID Varenicline is taken for a duration of 4 weeks in this study.	Transdermal Nicotine Patch n=73 Participants Participant randomized to receive active transdermal nicotine patch and placebo varenicline. transdermal nicotine patch: Weeks 0-3: 21mg patch Transdermal nicotine patch is used for a duration of 3 weeks in this study.	Total n=140 Participants Total of all reporting groups
Age, Continuous	30.7 years STANDARD_DEVIATION 7.9 • n=5 Participants	33.0 years STANDARD_DEVIATION 7.4 • n=7 Participants	31.9 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	73 Participants n=7 Participants	140 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants	57 Participants n=7 Participants	110 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Carbon monoxide (≤10 parts per million) verified abstinence during the last two weeks of treatment

Outcome measures

Measure	Varenicline n=67 Participants Participant randomized to receive active varenicline and placebo transdermal nicotine patch. varenicline: Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID Varenicline is taken for a duration of 4 weeks in this study.	Transdermal Nicotine Patch n=73 Participants Participant randomized to receive active transdermal nicotine patch and placebo varenicline. transdermal nicotine patch: Weeks 0-3: 21mg patch Transdermal nicotine patch is used for a duration of 3 weeks in this study.
End-of-treatment Abstinence	25 Participants	13 Participants

Adverse Events

Varenicline

Serious events: 0 serious events

Other events: 67 other events

Deaths: 0 deaths

Transdermal Nicotine Patch

Serious events: 1 serious events

Other events: 73 other events

Deaths: 0 deaths

Serious adverse events

Measure	Varenicline n=67 participants at risk Participant randomized to receive active varenicline and placebo transdermal nicotine patch. varenicline: Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID Varenicline is taken for a duration of 4 weeks in this study.	Transdermal Nicotine Patch n=73 participants at risk Participant randomized to receive active transdermal nicotine patch and placebo varenicline. transdermal nicotine patch: Weeks 0-3: 21mg patch Transdermal nicotine patch is used for a duration of 3 weeks in this study.
Skin and subcutaneous tissue disorders Rash	0.00% 0/67	1.4% 1/73 • Number of events 1
Infections and infestations Fever	0.00% 0/67	1.4% 1/73 • Number of events 1

Other adverse events

Measure	Varenicline n=67 participants at risk Participant randomized to receive active varenicline and placebo transdermal nicotine patch. varenicline: Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID Varenicline is taken for a duration of 4 weeks in this study.	Transdermal Nicotine Patch n=73 participants at risk Participant randomized to receive active transdermal nicotine patch and placebo varenicline. transdermal nicotine patch: Weeks 0-3: 21mg patch Transdermal nicotine patch is used for a duration of 3 weeks in this study.
Investigations All	100.0% 67/67 • Number of events 137	100.0% 73/73 • Number of events 170

Additional Information

Kevin M. Gray, M.D.

Medical University of South Carolina

Phone: 843-792-6330

Email: graykm@musc.edu

Results disclosure agreements

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