Nicotine Delivery Systems: Research & Treatment (NDS)

This study has been terminated.
(Common comorbidities of Veterans precluded sufficient recruitment and enrollment.)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108342
First received: April 14, 2005
Last updated: June 2, 2014
Last verified: June 2014
  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: Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing
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:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Quit Attempts, Use of NRTs, Preference Among NRTs [ Time Frame: At testing, at follow-up ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: October 2007
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Nina G. 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
Results First Received: December 19, 2013
Last Updated: June 2, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Nicotine
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

ClinicalTrials.gov processed this record on August 19, 2014