- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02905656
Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit (PACE)
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
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tennessee
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Memphis, Tennessee, United States, 38163
- University of Tennessee Health Science Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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Psychoeducation
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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.
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Guides participants toward choosing to make a change in their behavior with a collaborative conversation.
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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.
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Reducing the number of cigarettes consumed.
Nicotine Replacement Therapy in the form of gum.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Point Prevalence Tobacco Abstinence
Time Frame: 12 months from randomization
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Point prevalence (7 days without a cigarette, "not even a puff") is an appropriate measure in measuring long term outcome in cessation induction trials.
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12 months from randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prolonged Tobacco Abstinence
Time Frame: 12 months from randomization
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Prolonged abstinence will be defined as continuous abstinence from the point of initial cessation (with a two week grace period around the cessation date).
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12 months from randomization
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Klesges, PhD, University of Virginia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
product manufactured in and exported from the U.S.
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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