Nicotine Delivery Systems: Research & Treatment

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Non-Nicotine Agents for Smoking Cessation

NCT00108537

Tobacco Use Disorder

COMPLETED PHASE3

Varenicline for Smoking Reduction in Veterans Not Ready To Quit

NCT06966362

Veterans Tobacco Use Disorder Cigarette Smoking +1 more

NOT_YET_RECRUITING PHASE4

Effects of Random Nicotine Delivery on Smoking Cessation

NCT03674970

Smoking Cessation Cigarette Smoking Smoking (Tobacco) Addiction

COMPLETED PHASE1/PHASE2

Smoking Reduction or Cessation With Nicotine Replacement Therapy

NCT00840242

Smoking Cessation

COMPLETED PHASE3

An Exploratory Study Comparing Two Nicotine Inhalers

NCT01478230

Tobacco Dependence

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type ACTIVE_COMPARATOR

Nicotine gum - 2 mg and 4 mg

Intervention Type DRUG

Nicotine lozenges - 2 mg and 4 mg

Intervention Type DRUG

Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing

Intervention Type DRUG

can yield 4 mg from 10 mg device - infrequent and frequent puffing

NRT Computer Learning

Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only

Group Type SHAM_COMPARATOR

Computer learning

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nicotine gum - 2 mg and 4 mg

Intervention Type DRUG

Nicotine lozenges - 2 mg and 4 mg

Intervention Type 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

Intervention Type DRUG

Computer learning

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nicorette gum Nicorette Commit lozenges Nicotrol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes