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

February 28, 2024 updated by: Robert Klesges, University of Virginia

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

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.

Study Overview

Detailed Description

On the Society for Research in Nicotine and Tobacco definition of a cessation induction trial, which is a treatment that promotes cessation among all smokers, including those not ready to quit.1 One implication of this design is that success is based on percent abstinent at a given point in time and do not tie a follow-up to a determined quit date (since smokers not ready to quit often don't typically set formal quit dates).

Investigators research led to a four condition treatment design as the main independent variable of interest. Participants will be randomly assigned to four treatment conditions: (1) Brief advice; (2) motivational interviewing; (3) rate reduction; and (4) combination of motivational interviewing and rate reduction. All four intervention conditions will receive three sessions once a week, ideally, but can extend to a 6 week time period, each approximately 30 minutes in length, provided over a period of 4 to 6 weeks, depending on the participant's circumstances. Upon the completion of the main components, Booster sessions will be administered in 2-month increments throughout the intervention period (2 month, 4 month, & 6 month follow-up) in conjunction with study assessments. The window for the Booster sessions will be as indicated above 2M, 4M, and 6M after enrollment, but we will continue to try and reach them to complete the booster session for 4 weeks. For example, 2 month booster window opens at 8 weeks after enrollment and we will try to complete that 2 month booster within 4 weeks. Twelve months after randomization, prolonged abstinence will be measured.

Study Type

Interventional

Enrollment (Actual)

903

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Able to understand English
  • For the past 12 months, has smoked 5 or more cigarettes a day
  • 18 years or older
  • Planning on Quitting smoking someday
  • Access to a telephone
  • Willing and able to use NRT in the form of gum
  • Not currently using chantix or wellbutrin

Exclusion Criteria:

  • Planning to quit smoking cigarettes in the next 30 days
  • Currently pregnant, breastfeeding, or planning to become pregnant in the next 12 months
  • Currently using chantix or wellbutrin
  • Diagnosed with an unstable heart condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Brief Advice
Participants will receive brief advice to quit smoking, and be provided psycho-education citing health consequences and the positive impact on mortality and morbidity.
Psychoeducation
Experimental: Motivational Interviewing (MI)
Motivational interviewing (MI) is a collaborative conversation style for strengthening a person's own motivation and commitment to change. MI attempts to avoid a confrontational style and, instead, guides participants toward choosing to make a change in their behavior.
Guides participants toward choosing to make a change in their behavior with a collaborative conversation.
Experimental: Rate Reduction (RR)
Participants will be informed of the strong medical evidence of systematic reductions in smoking behavior can lead to long-term smoking cessation. This condition will receive Nicotine Replacement Therapy in the form of gum.
Reducing the number of cigarettes consumed.
Nicotine Replacement Therapy in the form of gum.
Experimental: MI + RR
In this intervention, participants receive both the skills based rate reduction intervention and the more motivationally based MI intervention. This condition will receive Nicotine Replacement Therapy in the form of gum.
Nicotine Replacement Therapy in the form of gum.
Combination of reducing the number of cigarettes consumed while guiding the participant to make a change in their behavior.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Point Prevalence Tobacco Abstinence
Time Frame: 12 months from randomization
Point prevalence (7 days without a cigarette, "not even a puff") is an appropriate measure in measuring long term outcome in cessation induction trials.
12 months from randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prolonged Tobacco Abstinence
Time Frame: 12 months from randomization
Prolonged abstinence will be defined as continuous abstinence from the point of initial cessation (with a two week grace period around the cessation date).
12 months from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert Klesges, PhD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

June 16, 2020

Study Completion (Actual)

June 16, 2020

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimated)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 15-04215-XP 0027114
  • 1R01CA193245-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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