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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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.


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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

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


Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Nina G. Schneider, PhD VA Greater Los Angeles Healthcare System, West LA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00108342     History of Changes
Obsolete Identifiers: NCT00876239
Other Study ID Numbers: NEUA-015-07S
First Posted: April 15, 2005    Key Record Dates
Results First Posted: June 4, 2014
Last Update Posted: June 4, 2014
Last Verified: June 2014

Keywords provided by VA Office of Research and Development:
nicotine
drug therapy
Smoking Cessation

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action