Trial Outcomes & Findings for Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation (NCT NCT00289653)

Last Updated: 2018-10-05

Results Overview

Expired Co levels were measured to confirm smoking status

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

measured at week 10

Results posted on

2018-10-05

Participant milestones
Measure	Nicotine Therapy + Counselling Nicotine replacement therapy + brief counselling
Overall Study STARTED	23
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	11

Withdrawal data not reported

Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation

Baseline characteristics by cohort
Measure	Enrolled Participants n=23 Participants All eligible enrolled participants
Age, Continuous	45.4 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Mean Cigarettes per day	25.7 cigarettes per day STANDARD_DEVIATION 13.4 • n=5 Participants
Carbon monoxide gas (CO) reading	23.1 ppm STANDARD_DEVIATION 11.5 • n=5 Participants
No. of previous serious quit attempts	4.7 Quit attempts STANDARD_DEVIATION 6.3 • n=5 Participants
No. years smoking	30.1 years STANDARD_DEVIATION 12.9 • n=5 Participants
Fagerstrom Test of Nicotine Dependence	6.3 units on a scale STANDARD_DEVIATION 2.3 • n=5 Participants
Hamilton Depression Rating Scale (HAM-D)	8.9 units on a scale STANDARD_DEVIATION 9.8 • n=5 Participants
Beck Depression Inventory (BDI) score	10.0 units on a scale STANDARD_DEVIATION 9.7 • n=5 Participants

Timeframe: measured at week 10

Expired Co levels were measured to confirm smoking status

Outcome measures
Measure	Enrolled Participants n=12 Participants 12 participants who completed the study
Carbon Monoxide Levels	9.2 parts per million Standard Deviation 6.3

Timeframe: Week 10

self reported # cigarettes per day

Outcome measures
Measure	Enrolled Participants n=12 Participants 12 participants who completed the study
Smoking Cessation	3.7 cigarettes per day Standard Deviation 4.0

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Enrolled Participants n=23 participants at risk participants who enrolled in the study
Respiratory, thoracic and mediastinal disorders adverse event- respiratory infection and colds	26.1% 6/23 • Number of events 9 • 10 weeks
Product Issues Skin irritation	34.8% 8/23 • Number of events 8 • 10 weeks
Product Issues sleep disturbance	30.4% 7/23 • Number of events 8 • 10 weeks
Product Issues Nausea and Vomitting	21.7% 5/23 • Number of events 5 • 10 weeks
Social circumstances Emotional Distress	8.7% 2/23 • Number of events 2 • 10 weeks
Psychiatric disorders Depressive Symptoms	8.7% 2/23 • Number of events 2 • 10 weeks
Gastrointestinal disorders Nausea	8.7% 2/23 • Number of events 2 • 10 weeks

Centre for Addiction and Mental Health

Phone: 416-535-8501