Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit

Summary

To our knowledge, no study has evaluated the independent effects of motivational interviewing and rate reduction, individually versus in combination, for motivating smokers who are not ready to quit (SNRTQ) to increase both quit attempts and tobacco abstinence. Given the disseminability and the fact that findings can be readily translated into the network of tobacco quitlines, we propose: (1) To test a tobacco quitline for SNRTQ, following methods that we have previously implemented and evaluated (HL-123978, CA-127964); (2) To randomize 828 SNRTQs to: (a) Brief Advice + typical smoking cessation resources (control group); (b) motivational interviewing format recommended by the Clinical Practice Guidelines; (c) behavioral and pharmacologic rate reduction, and (d) both motivational interviewing and behavioral and pharmacologic rate reduction. This design allows us to evaluate the independent and additive effects of motivational interviewing and rate reduction on quit attempts and smoking cessation.

We plan to evaluate the efficacy of the intervention utilizing point prevalence at the 12-month follow-up. The Society for Research in Nicotine and Tobacco consensus paper concluded that point prevalence (7 days without a cigarette, "not even a puff") is an appropriate measure in measuring long term outcome in cessation induction trials. Prolonged abstinence at the 12-month follow-up and quit attempts at the 2-, 4- and 6-month and the 12-month follow-up are secondary endpoints. Self-efficacy, level of smoking reduction, tobacco dependence, intentions, motivation, and confidence to quit, and intervention adherence (# sessions attended, amount of nicotine replacement therapy used) will be tested as important treatment mediators.

Conditions

• Smoking Cessation

Interventions

BEHAVIORAL

Brief Advice

Psychoeducation

BEHAVIORAL

Motivational Interviewing

Guides participants toward choosing to make a change in their behavior with a collaborative conversation.

BEHAVIORAL

Rate Reduction

Reducing the number of cigarettes consumed.

DRUG

Pharmacological

Nicotine Replacement Therapy in the form of gum.

BEHAVIORAL

MI+RR

Combination of reducing the number of cigarettes consumed while guiding the participant to make a change in their behavior.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Tennessee

  collaborator OTHER

• University of Virginia

  lead OTHER

Principal Investigators

• Robert Klesges, PhD · University of Virginia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2020-06-16

Completion

2020-06-16

Countries

• United States

Study Locations