Nicotine Dependence
Conditions
Keywords
nicotine dependence,, transdermal nicotine patch,, smoking while receiving nicotine replacement,, comorbidities
Brief summary
Smoking while on nicotine patches will help subjects to reduce their expired carbon monoxide levels from the levels they were before they started using the patch. Subjects will also decrease their daily consumption of cigarettes.
Detailed description
Subjects who smoke while on an individually dosed tNRT will reduce their expired carbon monoxide levels from pre- to post-treatment conditions. They will also decrease their daily consumption of cigarettes.
Interventions
DRUGNicoderm
Sponsors
Centre for Addiction and Mental Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 19 years of age * male or female * have intention to quit smoking within the next 6 months * smoke 10 or more cigarettes per day
Exclusion criteria
* Pregnant or not using an adequate enough method of birth control to ensure that they are not at risk of becoming pregnant * breastfeeding * have any generalized skin disorders * are in an immediate post-myocardial infarction period or have life-threatening arrhythmias, have severe or worsening angina pectoris or have had a recent cerebral vascular accident * are using additional nicotine replacement therapies or any other smoking cessation pharmacotherapy * any clinically significant ECG abnormalities * any known hypersensitivity to components of the transdermal system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carbon Monoxide Levels | measured at week 10 | Expired Co levels were measured to confirm smoking status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Cessation | Week 10 | self reported # cigarettes per day |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Participants All eligible enrolled participants | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Enrolled Participants |
|---|---|
| Age, Continuous | 45.4 years STANDARD_DEVIATION 12.4 |
| Beck Depression Inventory (BDI) score | 10.0 units on a scale STANDARD_DEVIATION 9.7 |
| Carbon monoxide gas (CO) reading | 23.1 ppm STANDARD_DEVIATION 11.5 |
| Fagerstrom Test of Nicotine Dependence | 6.3 units on a scale STANDARD_DEVIATION 2.3 |
| Hamilton Depression Rating Scale (HAM-D) | 8.9 units on a scale STANDARD_DEVIATION 9.8 |
| Mean Cigarettes per day | 25.7 cigarettes per day STANDARD_DEVIATION 13.4 |
| No. of previous serious quit attempts | 4.7 Quit attempts STANDARD_DEVIATION 6.3 |
| No. years smoking | 30.1 years STANDARD_DEVIATION 12.9 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 17 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Carbon Monoxide Levels
Expired Co levels were measured to confirm smoking status
Time frame: measured at week 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enrolled Participants | Carbon Monoxide Levels | 9.2 parts per million | Standard Deviation 6.3 |
Secondary
Smoking Cessation
self reported # cigarettes per day
Time frame: Week 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enrolled Participants | Smoking Cessation | 3.7 cigarettes per day | Standard Deviation 4 |