Nicotine Delivery Systems: Research & Treatment (NDS)
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.
|Smoking||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|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
|Official Title:||Nicotine Delivery Systems: Research and Treatment|
- 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.
|Study Start Date:||October 2007|
|Study Completion Date:||December 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 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).
Drug: Nicotine gum - 2 mg and 4 mg
Other Name: Nicorette gumDrug: Nicotine lozenges - 2 mg and 4 mg
Other Name: Nicorette Commit lozengesDrug: Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing
can yield 4 mg from 10 mg device - infrequent and frequent puffing
Other Name: Nicotrol
Sham Comparator: NRT Computer Learning
Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
|Other: Computer learning|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00108342
|United States, California|
|VA Greater Los Angeles Healthcare System, West LA|
|West Los Angeles, California, United States, 90073|
|Principal Investigator:||Nina G. Schneider, PhD||VA Greater Los Angeles Healthcare System, West LA|