Nicotine Delivery Systems: Research & Treatment

Smoking Clinical Trial

— NDS  

Official title:

Nicotine Delivery Systems: Research and Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00108342
• Other study ID #: NEUA-015-07S
• Status: Terminated
• Phase: N/A
• First received: April 14, 2005
• Last updated: June 2, 2014
• Start date: October 2007
• Est. completion date: December 2009

Study information

• Verified date: June 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00876239

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Smoking

Intervention

Drug:
• Nicotine gum - 2 mg and 4 mg

• Nicotine lozenges - 2 mg and 4 mg

• 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:
• Computer learning

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, West LA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quit Attempts, Use of NRTs, Preference Among NRTs	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.	At testing, at follow-up	No