Smoking
Conditions
Keywords
nicotine, drug therapy, Smoking Cessation
Brief summary
The purpose of this study is to determine whether sampling nicotine replacement treatments (NRTs) is superior to learning about them by computer. Testing also covers preferences among the treatments. Subjects will be enrolled veterans who smoke. Hypothesis: Direct experience (sampling) of NRTs will increase knowledge about NRTs, motivation/confidence, use of NRTs and quit attempts in contrast to learning about NRTs by computer.
Detailed description
The study was designed to compare sampling of several nicotine replacement treatments (NRTs) in contrast to a computer learning control. The NRTs include: 2 dosages of nicotine gum, 2 dosages of nicotine lozenges and 2 dosages of oral nicotine inhalers. In the sampling group, each participant tries each of the 6 NRTs for 3 minutes. In the control, the individuals read about the treatments. Dependent measures include: quit attempts, use of NRTs, preferences among NRTs, and learning and motivation.
Interventions
DRUGNicotine gum - 2 mg and 4 mg
DRUGNicotine lozenges - 2 mg and 4 mg
DRUGNicotine inhaler (4 mg yield) - low and high dosage by frequency of puffing
can yield 4 mg from 10 mg device - infrequent and frequent puffing
OTHERComputer learning
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be enrolled veteran who smokes.
Exclusion criteria
* Any event or condition that could be exacerbated by the local effects of nicotine treatments (e.g., throat or stomach problems; any kind of wheezing from a condition or medication) * other criteria as determined by PI and study physicians * reactions to menthol (inhaler) or to aspartame (lozenge)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quit Attempts, Use of NRTs, Preference Among NRTs | At testing, at follow-up | In addition to quit attempts, use of NRTs, and preference among NRTs, we also planned to assess learning and changes in motivation at all visits. Unfortunately, the study was terminated due to common comorbidities among the Veterans that precluded entry into the study. Due to the consequent small sample size, we did not analyze any data. |
Countries
United States
Participant flow
Pre-assignment details
25 enrollees gave their signed consent and were then screened for participation; a total of 17 participated in testing.
Participants by arm
| Arm | Count |
|---|---|
| NRT Sampling Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)
Nicotine gum - 2 mg and 4 mg
Nicotine lozenges - 2 mg and 4 mg
Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device) | 8 |
| NRT Computer Learning Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only | 9 |
| Total | 17 |
Baseline characteristics
| Characteristic | NRT Sampling | NRT Computer Learning | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 9 Participants | 17 Participants |
| Region of Enrollment United States | 8 participants | 9 participants | 17 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 8 | 0 / 0 |
| serious Total, serious adverse events | 0 / 8 | 0 / 0 |
Outcome results
Primary
Quit Attempts, Use of NRTs, Preference Among NRTs
In addition to quit attempts, use of NRTs, and preference among NRTs, we also planned to assess learning and changes in motivation at all visits. Unfortunately, the study was terminated due to common comorbidities among the Veterans that precluded entry into the study. Due to the consequent small sample size, we did not analyze any data.
Time frame: At testing, at follow-up
Population: The study was terminated and the data were not analyzed due to the small sample size.