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Nicotine Delivery Systems (NDS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108342
First received: April 14, 2005
Last updated: August 10, 2012
Last verified: August 2012
History of Changes
  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 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 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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Nicotine Delivery Systems: Research and Treatment

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Quit attempts, use of NRTs, preference [ Time Frame: At testing, at follow-up ] [ Designated as safety issue: No ]
    We are looking at pilot findings on learning, motivation and preferences for use of NRTs and information about the relationship among self-report, carbon monoxide and cotinine data.


Enrollment: 28
Study Start Date: October 2007
Study Completion Date: August 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
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
Sham Comparator: Arm 2
Computer learning = learning about 6 NRTs by computer only
 Other: Computer learning
Computer learning about 6 NRTs (3 forms x 2 dosages)

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 each. In the control, the individuals read about the treatments. Dependent measures include: learning, motivation, confidence, preferences among NRTs and quit attempts.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00108342

Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Nina Schneider, PhD VA Greater Los Angeles Healthcare System, West LA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108342     History of Changes
Obsolete Identifiers: NCT00876239
Other Study ID Numbers: NEUA-015-07S
Study First Received: April 14, 2005
Last Updated: August 10, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
nicotine
drug therapy
Smoking Cessation

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013