Nicotine Delivery Systems: Research & Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nicotine Delivery Systems: Research and Treatment

Conditions
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Smoking

Intervention / Treatment
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* Drug: Nicotine gum - 2 mg and 4 mg
* Drug: Nicotine lozenges - 2 mg and 4 mg
* Drug: Nicotine inhaler (4 mg yield) - low and high dosage by frequency of puffing
* Other: Computer learning


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nicotine Replacement Treatment (NRT) Sampling<br>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). | Drug: Nicotine gum - 2 mg and 4 mg<br> <br> * Other names: Nicorette gum;Drug: Nicotine lozenges - 2 mg and 4 mg<br> <br> * Other names: Nicorette Commit lozenges;Drug: Nicotine inhaler (4 mg yield) - low and high dosage by frequency of puffing<br>* can yield 4 mg from 10 mg device - infrequent and frequent puffing<br>* Other names: Nicotrol;|
| Sham Comparator: NRT Computer Learning<br>Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only | Other: Computer learning<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At testing, at follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nicotine, drug therapy, Smoking Cessation