Nicotine Delivery Systems: Research and Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Quit Attempts, Use of NRTs, Preference Among NRTs
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Nicotine Replacement Treatment (NRT) Sampling
Sampling = 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)
2 mg and 4 mg nicotine gum; 2 mg and 4 mg nicotine lozenges; frequent and infrequent puffing on a nicotine inhaler (can yield 4 mg from 10 mg device).
Intervention: Nicotine gum - 2 mg and 4 mg (Drug)
Nicotine Replacement Treatment (NRT) Sampling
Sampling = 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)
2 mg and 4 mg nicotine gum; 2 mg and 4 mg nicotine lozenges; frequent and infrequent puffing on a nicotine inhaler (can yield 4 mg from 10 mg device).
Intervention: Nicotine lozenges - 2 mg and 4 mg (Drug)
Nicotine Replacement Treatment (NRT) Sampling
Sampling = 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)
2 mg and 4 mg nicotine gum; 2 mg and 4 mg nicotine lozenges; frequent and infrequent puffing on a nicotine inhaler (can yield 4 mg from 10 mg device).
Intervention: Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing (Drug)
NRT Computer Learning
Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
Intervention: Computer learning (Other)
Outcomes
Primary Outcomes
Quit Attempts, Use of NRTs, Preference Among NRTs
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported