Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit
PACE
2 other identifiers
interventional
903
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 14, 2016
CompletedFirst Posted
Study publicly available on registry
September 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2020
CompletedMarch 1, 2024
February 1, 2024
3.8 years
September 14, 2016
February 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Point Prevalence Tobacco Abstinence
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 Outcomes (1)
Prolonged Tobacco Abstinence
12 months from randomization
Study Arms (4)
Brief Advice
PLACEBO COMPARATORParticipants will receive brief advice to quit smoking, and be provided psycho-education citing health consequences and the positive impact on mortality and morbidity.
Motivational Interviewing (MI)
EXPERIMENTALMotivational 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.
Rate Reduction (RR)
EXPERIMENTALParticipants 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.
MI + RR
EXPERIMENTALIn 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.
Interventions
Guides participants toward choosing to make a change in their behavior with a collaborative conversation.
Combination of reducing the number of cigarettes consumed while guiding the participant to make a change in their behavior.
Eligibility Criteria
You may qualify if:
- Able to understand English
- For the past 12 months, has smoked 5 or more cigarettes a day
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Virginialead
- National Cancer Institute (NCI)collaborator
- University of Tennesseecollaborator
Study Sites (1)
University of Tennessee Health Science Center
Memphis, Tennessee, 38163, United States
Related Publications (1)
Derefinko KJ, Bursac Z, Hand SB, Ebbert JO, Womack C, Klesges RC. Planning a Change Easily (PACE) for smokers who are not ready to quit: a telephone-based, randomized controlled trial. Addiction. 2022 Jun;117(6):1748-1757. doi: 10.1111/add.15796. Epub 2022 Feb 1.
PMID: 34985171DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Klesges, PhD
University of Virginia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Public Health Sciences
Study Record Dates
First Submitted
September 14, 2016
First Posted
September 19, 2016
Study Start
September 1, 2016
Primary Completion
June 16, 2020
Study Completion
June 16, 2020
Last Updated
March 1, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share