Nicotine Delivery Systems: Research & Treatment (NDS)

June 2, 2014 updated by: US Department of Veterans Affairs

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • West Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System, West LA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Nicorette gum
Drug: Nicotine lozenges - 2 mg and 4 mg
Other Names:
  • 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 Names:
  • Nicotrol
SHAM_COMPARATOR: NRT Computer Learning
Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
Other: Computer learning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quit Attempts, Use of NRTs, Preference Among NRTs
Time Frame: 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.
At testing, at follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Nina G. Schneider, PhD, VA Greater Los Angeles Healthcare System, West LA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

April 14, 2005

First Submitted That Met QC Criteria

April 14, 2005

First Posted (ESTIMATE)

April 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2014

Last Update Submitted That Met QC Criteria

June 2, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEUA-015-07S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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