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| Sponsored by: |
Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00108342 |
Purpose
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 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 | Intervention |
|---|---|
|
Smoking |
Drug: Nicotine gum - 2 mg and 4 mg Drug: Nicotine lozenges - 2 mg and 4 mg Drug: inhaler (10 mg yielding 4 mg) Other: Computer learning |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | Nicotine Delivery Systems: Research and Treatment |
| Estimated Enrollment: | 600 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)
|
Drug: Nicotine gum - 2 mg and 4 mg
Nicotine replacement treatment
Drug: Nicotine lozenges - 2 mg and 4 mg
Nicotine replacement treatment
Drug: inhaler (10 mg yielding 4 mg)
Nicotine replacement treatment
|
|
2: Sham Comparator
Computer learning = learning about 6 NRTs by computer only
|
Other: Computer learning
Computer learning about 6 NRTs (3 forms x 2 dosages)
|
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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)
Contacts and Locations| Contact: Nina Schneider, PhD | (310) 478-3711 ext 44318 | nina.schneider@va.gov |
| United States, California | |
| VA Greater Los Angeles Healthcare System, West LA | Recruiting |
| West Los Angeles, California, United States, 90073 | |
| Contact: Nina Schneider, PhD 310-478-3711 ext 44318 nina.schneider@va.gov | |
| Principal Investigator: Nina Schneider, PhD | |
| Principal Investigator: | Nina Schneider, PhD | VA Greater Los Angeles Healthcare System, West LA |
More Information
| Responsible Party: | Department of Veterans Affairs ( Schneider, Nina - Principal Investigator ) |
| Study ID Numbers: | NEUA-015-07S, ADRD-020-02S |
| Study First Received: | April 14, 2005 |
| Last Updated: | April 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00108342 History of Changes |
| Health Authority: | United States: Federal Government |
|
nicotine drug therapy Smoking Cessation |
|
Nicotine polacrilex Smoking Neurotransmitter Agents Nicotine |
Nicotinic Agonists Central Nervous System Stimulants Peripheral Nervous System Agents Cholinergic Agents |
|
Nicotine polacrilex Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Nicotinic Agonists Physiological Effects of Drugs Central Nervous System Stimulants Cholinergic Agents Pharmacologic Actions |
Smoking Habits Nicotine Autonomic Agents Therapeutic Uses Ganglionic Stimulants Peripheral Nervous System Agents Central Nervous System Agents |
