Computer-Assisted Scheduling of Nicotine Inhaler Use in Participants Who Plan to Stop Smoking

2014-07-23 21:55:49 | BioPortfolio


RATIONALE: Computer-assisted scheduling of nicotine inhaler use may be an effective method to help people stop smoking.

PURPOSE: Randomized cinical trial to compare the effectiveness of computer-assisted scheduling of nicotine inhaler use with that of self-scheduled nicotine inhaler use in participants who plan to stop smoking.


OBJECTIVES: I. Determine the effect of program length on inhaler use compliance, latency to smoking relapse, and gradual cessation of inhaler use in participants using a computer-assisted program to schedule nicotine inhaler dosing for smoking cessation. II. Compare fast and slow paced versions of computer-assisted scheduling of nicotine inhaler use versus ad libitum nicotine inhaler use, in terms of smoking cessation rates, in these participants. III. Compare these dosing conditions, in terms of adherence, initial dosing levels, and successful tapering effects, in these participants.

OUTLINE: This is a randomized study. Participants are randomized to one of three arms. All participants monitor their period of cigarette smoking for 7 days by pressing a data input button on a hand-held computer every time they smoke. Arm I: Participants begin using a nicotine inhaler according to the dosing instructions that come with it and monitor their inhaler usage with the hand-held computer. Arm II: Participants are prompted by the hand-held computer to use a nicotine inhaler based on their prior smoking habits. When prompted, participants use the nicotine inhaler at a comfortable rate over 20 minutes. The computer prompts participants at a fixed frequency and duration of inhaler use for 3 weeks and then tapers the frequency and duration over 3-5 weeks. Arm III: Participants are prompted by the hand-held computer and use a nicotine inhaler as in arm II. The computer prompts participants at a fixed frequency and duration of inhaler use for 12 weeks and then tapers the frequency and duration over 3-5 weeks. Participants keep a weekly diary of the average number of cigarettes smoked, average number of inhaler sessions, and average length of each session. Participants also record the date of any 24-hour smoking cessation and relapse and complete a withdrawal symptoms questionnaire. Participants are followed at 1 year.

PROJECTED ACCRUAL: A total of 480 participants will be accrued for this study.

Study Design

Primary Purpose: Prevention


Esophageal Cancer


smoking cessation intervention, nicotine


Personal Improvement Computer Systems, Incorporated
United States




National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:55:49-0400

Clinical Trials [2526 Associated Clinical Trials listed on BioPortfolio]

Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation

The goal of this study is to evaluate the effects of a smoking cessation intervention combining behavioral treatment with low nicotine cigarettes on neuroimaging measures of reward functio...

In-patient Smoking Cessation Intervention Using Counseling, Spirometry and Nicotine Replacement Therapy

The objective of the study is to assess the effect of in-hospital intensive counseling and NRT (nicotine replacement therapy) vs. usual care, on smoking cessation or enrollment to smoking ...

Mobile Contingency Management for Smoking Cessation in Returning US Veterans

The primary goal of the study is to evaluate the effectiveness of a combined tele-health and contingency management (CM) intervention that the investigators call mobile CM, or mCM, in prom...

Evaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) Low-frequency on Craving in Smoking Dependence

The fight against smoking is a public health priority. Without help, fewer than 5% of des smokers are abstinent at 12 months after smoking cessation. Despite well-managed attempts at smok...

Effects of Random Nicotine Delivery on Smoking Cessation

The objective of this study is to determine whether treatment with random nicotine delivery via a nicotine film both before and after the target quit date will facilitate smoking cessation...

PubMed Articles [18194 Associated PubMed Articles listed on BioPortfolio]

Smoking Cessation and Risk of Esophageal Cancer by Histological Type: Systematic Review and Meta-analysis.

Tobacco smoking strongly increases risk of esophageal squamous cell carcinoma and moderately increases risk of esophageal adenocarcinoma. How smoking cessation influences esophageal cancer risk across...

Evaluation of a randomized clinical trial comparing the effectiveness of a culturally targeted and non-targeted smoking cessation intervention for lesbian, gay, bisexual and transgender (LGBT) smokers.

To examine the benefits of a culturally targeted compared to a non-targeted smoking cessation intervention on smoking cessation outcomes among LGBT smokers.

Patient-Physician Discussions on Lung Cancer Screening: A Missed Teachable Moment to Promote Smoking Cessation.

Little is known about whether patients and physicians perceive lung cancer screening as a teachable moment to promote smoking cessation or the degree to which physicians in 'real world' settings link ...

Level of Alcohol Consumption and Successful Smoking Cessation.

The negative association between heavy alcohol use and likelihood of successful smoking cessation is well established. However, evidence on the effects of moderate alcohol consumption on smoking cessa...

Comparison of nicotine exposure during pregnancy when smoking and abstinent with nicotine replacement therapy: systematic review and meta-analysis.

Smoking during pregnancy is strongly associated with negative pregnancy and perinatal outcomes. Some guidelines recommend nicotine replacement therapy (NRT) for smoking cessation during pregnancy but ...

Medical and Biotech [MESH] Definitions

A decrease in the incidence and frequency of SMOKING. Smoking reduction differs from SMOKING CESSATION in that the smoker continues to smoke albeit at a lesser frequency without quitting.

An alkaloid that has actions similar to NICOTINE on nicotinic cholinergic receptors but is less potent. It has been proposed for a variety of therapeutic uses including in respiratory disorders, peripheral vascular disorders, insomnia, and smoking cessation.

Discontinuation of the habit of smoking, the inhaling and exhaling of tobacco smoke.

SMOKING of non-TOBACCO (or NICOTINE-containing) substances.

Cessation of the habit of using tobacco products for smoking or chewing, including the use of snuff.

More From BioPortfolio on "Computer-Assisted Scheduling of Nicotine Inhaler Use in Participants Who Plan to Stop Smoking"

Quick Search


Relevant Topic

  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Searches Linking to this Trial