Skip to main content
OpenTrials
Completed

NCT Number: NCT02905656

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Advice

Behavioral

Psychoeducation

Motivational Interviewing

Behavioral

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

Rate Reduction

Behavioral

Reducing the number of cigarettes consumed.

Pharmacological

Drug

Nicotine Replacement Therapy in the form of gum.

MI+RR

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of Tennessee

Registry information

Official study title

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

Acronym: PACE

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 19, 2016
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.