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

April 14, 2005
June 2, 2014
October 2007
September 2009   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00108342 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Nicotine Delivery Systems: Research & Treatment
Nicotine Delivery Systems: Research and Treatment

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Smoking
  • 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
  • Other: Computer learning
  • 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).

    Interventions:
    • 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
  • Sham Comparator: NRT Computer Learning
    Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
    Intervention: Other: Computer learning
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
December 2009
September 2009   (final data collection date for primary outcome measure)

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)
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00108342
NEUA-015-07S
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Nina G. Schneider, PhD VA Greater Los Angeles Healthcare System, West LA
Department of Veterans Affairs
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP