Drug Addiction, Smoking Cessation
Conditions
Keywords
Nicotine Replacement Therapy, Tobacco Smoking, Smoking stimuli, Gender
Brief summary
Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. The purpose of this study is to determine the role that gender plays in the effectiveness of nicotine replacement therapy. In addition, the purpose of this study is to determine whether men and women differ in their response to smoking-related stimuli (e.g., taste or smell of a lit cigarette). Conclusions drawn from this study may help to improve cessation interventions for all smokers, particularly women.
Detailed description
Currently,about 70 percent of smokers who try to quit by using smoking cessation treatments are unsuccessful. Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. There is no clear explanation for this difference, but it may involve a differential response to nicotine replacement treatments (NRTs) and/or smoking-related stimuli. For women, NRT may be less effective at suppressing withdrawal or blunting the effects of smoking during a quit attempt. Women may also be more sensitive to smoking-related stimuli, suc has the taste, sight, or smell of cigarette smoke. Tailoring treatments to the separate needs of smoker subgroups , such as men and women, my produce better cessation outcomes. The purpose of this study is to assess whether men and women differ in the their response to NRT (i.e., transdermal nicotine) and smoking-related stimuli. Participants in this double-blind, dose-comparison study will complete separate sessions in random order. Each session will last approximately 6.5 hours and will correspond to a transdermal patch dose (0 or 21mg) and cigarette type (denicotinized and nicotinized). Objectively verified cigarette abstinence will be required before each session. Sessions will occur at least 48 hours apart to avoid carryover. At the beginning of each session a patch will be placed on the participant's back and at 4, 5, and 6 hours after patch application the participant will smoke a cigarette (all identifying marking on the cigarette will be covered for blinding purposes). Physiological, subjective, cognitive, and smoking behavior outcomes will be collected during study visits.
Interventions
21 mg nicotine transdermal system
Placebo nicotine patch
OTHERNicotine containing cigarette
Nicotine containing cigarette
OTHERPlacebo cigarette
Non nicotine containing cigarette
Sponsors
National Institute on Drug Abuse (NIDA)
Virginia Commonwealth University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
include, but are not limited to: 18-50 years of age Smokes 15 cigarettes/day for at least 2 years Healthy (as determined by a brief study physical with medical doctor) Displays understanding of cognitive tasks.
Exclusion criteria
include, but are not limited to: History of chronic health problems or psychiatric conditions History of cardiovascular disease, low or high blood pressure, seizures, head injuries requiring hospital care, peptic ulcer, or diabetes Pregnancy (tested by urinalysis) Scores greater than 17 on the Beck Depression Inventory Lack of a high school degree or GED
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Effects | 6 hours | The full scale name is the Urge to smoke visual analog scale (VAS). It measures self-reported urge to smoke. As with any VAS a word or phrase (in this case, Urge to Smoke is centered over a horizontal line anchored on the left by not at all and on the right by extremely. In this study, participants used a mouse to produce a vertical mark on the horizontal line, and the score was the distance of the mark from the left anchor expressed as a percentage of total line length. Thus, the minimum was 0 (not at all) and the maximum score was 100 (extremely). |
Countries
United States
Participant flow
Recruitment details
Recruitment via media advertisement and flyer. Recruitment began 9/14/2005 and ended 1/30/2008.
Pre-assignment details
Enrolled (i.e., consented) participants were excluded if they failed to meet safety criteria (e.g., blood pressure) measured after the informed consent was given.
Participants by arm
| Arm | Count |
|---|---|
| All Participants In this study, overnight abstinent smokers completed four, double-blind laboratory sessions corresponding to a 2x2 design where transdermal nicotine dose (TN, 0 or 21 mg) was crossed with type of cigarette (nicotine-containing \[NIC\] or not \[DENIC\]). Cigarettes were smoked 4 hours after TN administration. | 124 |
| Total | 124 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 124 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 80 | 0 / 80 | 0 / 80 | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 | 0 / 80 | 0 / 80 |
Outcome results
Primary
Subjective Effects
The full scale name is the Urge to smoke visual analog scale (VAS). It measures self-reported urge to smoke. As with any VAS a word or phrase (in this case, Urge to Smoke is centered over a horizontal line anchored on the left by not at all and on the right by extremely. In this study, participants used a mouse to produce a vertical mark on the horizontal line, and the score was the distance of the mark from the left anchor expressed as a percentage of total line length. Thus, the minimum was 0 (not at all) and the maximum score was 100 (extremely).
Time frame: 6 hours
Population: Those who completed all four arms of the crossover study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ActiveP/ActiveC | Subjective Effects | 18.8 units on a scale | Standard Deviation 24.7 |
| PlaceboP/ActiveC | Subjective Effects | 23.1 units on a scale | Standard Deviation 24.5 |
| Active P/PlaceboC | Subjective Effects | 25.6 units on a scale | Standard Deviation 28.8 |
| PlaceboP/PlaceboC | Subjective Effects | 24.2 units on a scale | Standard Deviation 25.8 |