NCT00021138

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2001

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 19, 2004

Completed
Last Updated

May 15, 2013

Status Verified

March 1, 2011

First QC Date

July 11, 2001

Last Update Submit

May 14, 2013

Conditions

Esophageal CancerHead and Neck CancerLung Cancer

Keywords

non-small cell lung cancersmall cell lung canceresophageal cancerhypopharyngeal cancerlaryngeal cancernasopharyngeal canceroropharyngeal cancerlip and oral cavity cancerparanasal sinus and nasal cavity cancertongue cancer

Interventions

smoking cessation interventionBEHAVIORAL
nicotineDRUG

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Smoker with a daily smoking rate between 15 and 40 cigarettes per day for at least 2 years Willing to quit smoking Willing to use a nicotine inhaler No concurrent use of smokeless tobacco, pipes, or cigars PATIENT CHARACTERISTICS: Age: 18 to 67 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No liver disease Renal: No kidney disease Cardiovascular: No history of heart disease No high blood pressure Other: No stomach ulcers No overactive thyroid Not pregnant or nursing No plans to become pregnant within the next 6 months PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent insulin Radiotherapy: Not specified Surgery: Not specified Other: At least 1 month since prior bupropion or antidepressants At least 1 year since prior treatment for substance abuse No other concurrent nicotine replacement products

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Personal Improvement Computer Systems, Incorporated

Reston, Virginia, 20191, United States

Location

MeSH Terms

Conditions

Esophageal NeoplasmsHead and Neck NeoplasmsLung NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaHypopharyngeal NeoplasmsLaryngeal NeoplasmsNasopharyngeal NeoplasmsOropharyngeal NeoplasmsMouth NeoplasmsTongue Neoplasms

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesLaryngeal DiseasesNasopharyngeal DiseasesMouth DiseasesTongue Diseases

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • William Riley, PhD

    Personal Improvement Computer Systems

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2001

First Posted

March 19, 2004

Study Start

April 1, 2001

Study Completion

March 1, 2004

Last Updated

May 15, 2013

Record last verified: 2011-03

Locations

US(1)