Smoking CessationPACENCT02905656
Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit
A study testing Brief Advice, Motivational Interviewing and Rate Reduction in people with Smoking Cessation, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Brief Advice, Motivational Interviewing and Rate Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 903 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 16 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Brief Advice, Motivational Interviewing, Rate Reduction, Pharmacological, MI+RR
- Keywords
- quitline, nicotine replacement therapy, tobacco intervention, smokers not ready to quit
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief AdviceBehavioural
Psychoeducation
Motivational InterviewingBehavioural
Guides participants toward choosing to make a change in their behavior with a collaborative conversation.
Rate ReductionBehavioural
Reducing the number of cigarettes consumed.
PharmacologicalDrug
Nicotine Replacement Therapy in the form of gum.
MI+RRBehavioural
Combination of reducing the number of cigarettes consumed while guiding the participant to make a change in their behavior.
| Study group | Role | What they receive |
|---|---|---|
| Brief Advice | Placebo comparator | Participants will receive brief advice to quit smoking, and be provided psycho-education citing health consequences and the positive impact on mortality and morbidity. Receives: Behavioral: Brief Advice |
| Motivational Interviewing (MI) | Experimental | 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. Receives: Behavioral: Motivational Interviewing |
| Rate Reduction (RR) | Experimental | 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. Receives: Behavioral: Rate Reduction; Drug: Pharmacological |
| MI + RR | Experimental | 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. Receives: Drug: Pharmacological; Behavioral: MI+RR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months from randomization
Secondary outcomes (1)
Prolonged Tobacco Abstinence
Prolonged abstinence will be defined as continuous abstinence from the point of initial cessation (with a two week grace period around the cessation date).
Measured: 12 months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion16 Jun 2020
- Study completion16 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 903 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Tennessee
- Responsible party
- Principal investigator, Robert Klesges, University of Virginia
- Investigators
- Robert Klesges, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905656
- Sponsor's protocol ID
- 15-04215-XP 0027114
- Other IDs
- 1R01CA193245-01A1
- Acronym
- PACE
- Status last verified
- Feb 2024
- First submitted
- 14 Sep 2016
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
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.
PubMed 34985171
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit (PACE)
- ClinicalTrials.gov ID
- NCT02905656
- Acronym / sponsor ID
- PACE / 15-04215-XP 0027114
- Conditions
- Smoking Cessation
- Keywords
- quitline, nicotine replacement therapy, tobacco intervention, smokers not ready to quit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 903 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Tennessee
- Study start
- Sep 2016 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Brief Advice | Placebo comparator | Behavioral: Brief AdviceParticipants 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) | Experimental | Behavioral: Motivational InterviewingMotivational 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) | Experimental | Behavioral: Rate Reduction, Drug: PharmacologicalParticipants 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 | Experimental | Drug: Pharmacological, Behavioral: MI+RRIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief AdvicePsychoeducation | Behavioural | Brief Advice |
| Motivational InterviewingGuides participants toward choosing to make a change in their behavior with a collaborative conversation. | Behavioural | Motivational Interviewing (MI) |
| Rate ReductionReducing the number of cigarettes consumed. | Behavioural | Rate Reduction (RR) |
| PharmacologicalNicotine Replacement Therapy in the form of gum. | Drug | MI + RR, Rate Reduction (RR) |
| MI+RRCombination of reducing the number of cigarettes consumed while guiding the participant to make a change in their behavior. | Behavioural | MI + RR |
Primary outcome
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.
1 secondary outcome
Prolonged Tobacco Abstinence
Time frame: 12 months from randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Derived from this study: PubMed 34985171Derefinko 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Klesges, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Advice, Motivational Interviewing and Rate Reduction in people with Smoking Cessation, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point Prevalence Tobacco Abstinence (time frame: 12 months from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02905656, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.