Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02905656
Acronym
PACE
Enrollment
903
Registered
2016-09-19
Start date
2016-09-30
Completion date
2020-06-16
Last updated
2024-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

quitline, nicotine replacement therapy, tobacco intervention, smokers not ready to quit

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.

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.

Interventions

BEHAVIORALBrief Advice

Psychoeducation

BEHAVIORALMotivational Interviewing

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

BEHAVIORALRate Reduction

Reducing the number of cigarettes consumed.

DRUGPharmacological

Nicotine Replacement Therapy in the form of gum.

BEHAVIORALMI+RR

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Tennessee
CollaboratorOTHER
University of Virginia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Point Prevalence Tobacco Abstinence12 months from randomizationPoint prevalence (7 days without a cigarette, not even a puff) is an appropriate measure in measuring long term outcome in cessation induction trials.

Secondary

MeasureTime frameDescription
Prolonged Tobacco Abstinence12 months from randomizationProlonged abstinence will be defined as continuous abstinence from the point of initial cessation (with a two week grace period around the cessation date).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026