Nicotine Delivery Systems: Research & Treatment

Not Applicable

Terminated

• Conditions: Smoking
• Interventions: Drug: Nicotine gum - 2 mg and 4 mg; Other: Computer learning; Drug: Nicotine lozenges - 2 mg and 4 mg; Drug: Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing

• Registration Number: NCT00108342
• Lead Sponsor: US Department of Veterans Affairs

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2005-04-14
• Study First Submitted QC: 2005-04-14
• Study First Posted: 2005-04-15
• Study Start: 2007-10
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Results First Submitted: 2013-12-19
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-02
• Last Update Submitted: 2014-06-02
• Results First Posted: 2014-06-04
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Must be enrolled veteran who smokes.

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine Replacement Treatment (NRT) Sampling	Nicotine gum - 2 mg and 4 mg	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).
Nicotine Replacement Treatment (NRT) Sampling	Nicotine lozenges - 2 mg and 4 mg	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).
Nicotine Replacement Treatment (NRT) Sampling	Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing	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).
NRT Computer Learning	Computer learning	Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only

Primary Outcome Measures

Name	Time	Method
Quit Attempts, Use of NRTs, Preference Among NRTs	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.

Trial Locations

Locations (1)

VA Greater Los Angeles Healthcare System, West LA; 🇺🇸 West Los Angeles, California, United States