CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 560 target
Drug / intervention
Usual care +2 morebehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01866722
NCT01866722N/ACompleted

A Test of Two Clinical Methods to Prompt a Quit Attempt Among Smokers

University of Vermont·interventional·Posted May 31, 2013·Updated Jul 31, 2017

In Brief

A clinical study evaluating Usual care, Reduction, and 1 other intervention for Smoking Cessation. Completed, enrolled 560 participants across 1 site.

Detailed Summary

In our communications with the public, the investigators will call this the Not Quite Ready to Quit Smoking Study. One new method to increase quit attempts is to have smokers reduce their cigs/day. The investigators and others have shown that reduction aided by nicotine medications can increase quit attempts and later abstinence among smokers not ready to quit. Because half of smokers are reluctant to use nicotine medications for a non-cessation reason, the investigators now propose to test whether reduction not aided by nicotine medications can be effective. Another new method to increase quit attempts is motivational counseling. The investigators previously found implementation of the brief United States Public Health Service (USPHS) Guidelines 5 Rs motivational intervention via three 15 min phone calls can provide a large increase in quitting (OR = 6.3); however, the investigators need to replicate that result. A vendor will proactively email adult, daily smokers listed in a consumer panel to recruit 560 smokers who do not plan to quit in the next month and randomize them to a) reduction counseling without the aid of nicotine medications , b) brief counseling guided by the USPHS 5 R's, or c) usual care. The first two conditions will be delivered via brief counseling calls at study onset and then 2 and 4 weeks later (total = 35 min). The usual care condition will consist of a brief (\< 5 min) phone intervention followed by a quit guide. Our major hypothesis is that the incidence of quit attempts over the 6 months of the study will be greater in both the reduction and the motivational conditions than in the usual care condition. A secondary hypothesis is that the increase in quit attempts will lead to increased abstinence. Another secondary hypothesis is that beneficial effects of both treatments will be mediated by increases in self-efficacy and intentions to quit. A final hypothesis is that decreases in cigs/day and nicotine dependence will mediate the efficacy of the reduction treatment but not the motivational treatment and, conversely, that a shift in decisional balance will mediate the efficacy of the motivational treatment but not of the reduction treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 31, 2013
Enrollment StartSep 1, 2013
Primary CompletionJan 10, 2015
Study CompletionJul 14, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.1 years ago

Interventions

Usual carebehavioral

Participants will get a brief (\<5 min) telephone counseling session about quitting. After that, printed materials with resources to help quitting will be mailed to the participants.

Reductionbehavioral

Participants will have 3 telephone counseling sessions that focus on ways to reduce tobacco cigarette smoking. After the final session printed materials with resources to help quitting will be mailed to the participants.

5Rsbehavioral

Participants will have 3 telephone counseling sessions that focus on the 5Rs for quitting tobacco cigarette smoking (Relevance, Risks, Rewards, Roadblocks, Repeat). After the final session printed materials with resources to help quitting will be mailed to the participants.