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Not Quite Ready to Quit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01866722
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : July 31, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
John Hughes, University of Vermont

Brief 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.


Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Usual care Behavioral: Reduction Behavioral: 5Rs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Test of Two Clinical Methods to Prompt a Quit Attempt Among Smokers
Actual Study Start Date : September 2013
Actual Primary Completion Date : January 10, 2015
Actual Study Completion Date : July 14, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Active Comparator: Usual Care
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.
Behavioral: Usual care
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.

Active Comparator: Reduction
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.
Behavioral: Reduction
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.

Active Comparator: 5Rs
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.
Behavioral: 5Rs
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.




Primary Outcome Measures :
  1. quit attempts [ Time Frame: About 2 years ]
    The incidence of an attempt to quit smoking tobacco cigarettes during the 6 months of the study.


Secondary Outcome Measures :
  1. abstinence [ Time Frame: About 2 years ]
    7 day point prevalence abstinence from smoking tobacco cigarettes at 6 months after the beginning of treatment.


Other Outcome Measures:
  1. prolonged abstinence [ Time Frame: about 2 years ]
    Abstinence from tobacco cigarette smoking during the last 3 months of the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 18 years old
  • smoke > 10 cigs/day seven days/week,
  • wants to stop at some point but have no plans to quit in the next month
  • is able to read and write English
  • is a US citizen or a permanent resident alien
  • available for counseling calls before 20:00 Eastern Time

Exclusion Criteria:

  • has reduced cigs/day by > 25% in the last month
  • has used non-cigarette tobacco in the last month
  • has used electronic cigarettes, nicotine replacement medications, varenicline or bupropion in the last month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866722


Locations
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United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
National Cancer Institute (NCI)
Investigators
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Principal Investigator: John R Hughes, MD University of Vermont
Publications of Results:
Other Publications:
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Responsible Party: John Hughes, Principal Investigator, University of Vermont
ClinicalTrials.gov Identifier: NCT01866722    
Other Study ID Numbers: CHRBS B12-268
R01CA163176 ( U.S. NIH Grant/Contract )
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Keywords provided by John Hughes, University of Vermont:
nicotine dependence
smoking cessation
lapse
relapse
tobacco
quit attempts
abstinence
motivation
reduction