CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,034 enrolled
Drug / intervention
CIS - telephone cessation quitline counseling +6 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01342523
NCT01342523Phase 4Completed
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Evaluation of NCI Smoking Intervention Resources

University of Wisconsin, Madison·interventional·Posted Apr 27, 2011·Updated Oct 14, 2015

In Brief

A Phase 4 clinical trial evaluating CIS - telephone cessation quitline counseling, Lozenge - nicotine mini-lozenges, and 5 other interventions for Smoking Cessation and 2 related conditions. Completed, enrolled 1,034 participants across 1 site.

Detailed Summary

This is an evaluative study of three National Cancer Institute (NCI) smoking cessation resources: specifically, the smokefree.gov and women smokefree.gov websites, and the CIS counseling phone calls. The following are the identified critical questions: (1). How effective is each of the tobacco interventions (websites \[smokefree.gov \& women smokefree.gov\], NCI's Cessation Quitline counseling services operated by the Cancer Information Service (CIS) (2). How do they compare with alternative intervention strategies? (3). Which types of interventions appear to work best together (due to additive or interactive effects)? (4). How do these interventions work? (5). How much are these interventions used, and what are their relative use rates? (6). Are there important differences in effectiveness or use rates as a function of gender, SES, or other important person factors? We believe that the research study will address all of these questions, as well as some less central ones.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation, Smoking, Nicotine Dependence
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Fred Hutchinson Cancer Center

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 27, 2011
Enrollment StartOct 1, 2011
Primary CompletionMay 1, 2012
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.2 years ago

Interventions

CIS - telephone cessation quitline counselingother

Up to 5 total tobacco cessation counseling calls

Lozenge - nicotine mini-lozengesother

2-week starter pack of nicotine mini-lozenges

Emails - Brief smoking prevention messagesother

Brief email messages that could be accessed by any computer or mobile device that allowed email receipt

Full website - standard smokefree.gov website contentother

Over 50 web pages of resources for quitting smoking, including interactive features and referral links

Lite website - lite version of smokefree.govother

Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)

Full mailed booklet - NCI's detailed 36-page quit guideother

NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse

brief mailed booklet - smaller version of NCI's bookletother

12-page booklet developed by the investigators for the research (considered to be placebo intervention)