Nicotine Delivery Systems: Research & Treatment (NDS)
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|ClinicalTrials.gov Identifier: NCT00108342|
Recruitment Status : Terminated (Common comorbidities of Veterans precluded sufficient recruitment and enrollment.)
First Posted : April 15, 2005
Results First Posted : June 4, 2014
Last Update Posted : June 4, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nicotine Delivery Systems: Research and Treatment|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||December 2009|
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 gum
Drug: Nicotine lozenges - 2 mg and 4 mg
Other Name: Nicorette Commit lozenges
Drug: 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|