Not Quite Ready to Quit

NCT01866722 | Completed

• 2 other identifiers: CHRBS B12-268R01CA163176
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

nicotine dependence; smoking cessation; lapse; relapse; tobacco; quit attempts; abstinence; motivation; reduction

Outcome Measures

Primary Outcomes (1)

• quit attempts

  The incidence of an attempt to quit smoking tobacco cigarettes during the 6 months of the study.

  About 2 years

Secondary Outcomes (1)

• abstinence

  About 2 years

Other Outcomes (1)

• prolonged abstinence

  about 2 years

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

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

Reduction

ACTIVE COMPARATOR

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

5Rs

ACTIVE COMPARATOR

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

Interventions

Usual care BEHAVIORAL

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.

Usual Care

Reduction BEHAVIORAL

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.

Reduction

5Rs BEHAVIORAL

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.

5Rs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Vermont

Burlington, Vermont, 05401, United States

Location

Related Publications (3)

• Wewers ME, Stillman FA, Hartman AM, Shopland DR. Distribution of daily smokers by stage of change: Current Population Survey results. Prev Med. 2003 Jun;36(6):710-20. doi: 10.1016/s0091-7435(03)00044-6.

  PMID: 12744915 BACKGROUND

• Carpenter MJ, Hughes JR, Keely JP. Effect of smoking reduction on later cessation: a pilot experimental study. Nicotine Tob Res. 2003 Apr;5(2):155-62. doi: 10.1080/146222003100007385.

  PMID: 12745487 BACKGROUND

• Klemperer EM, Hughes JR, Solomon LJ, Callas PW, Fingar JR. Motivational, reduction and usual care interventions for smokers who are not ready to quit: a randomized controlled trial. Addiction. 2017 Jan;112(1):146-155. doi: 10.1111/add.13594. Epub 2016 Oct 5.

  PMID: 27566993 RESULT

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder; Recurrence

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John R Hughes, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 31, 2013
• Study Start: September 1, 2013
• Primary Completion: January 10, 2015
• Study Completion: July 14, 2015
• Last Updated: July 31, 2017

Record last verified: 2017-07

Locations

US (1)