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

University of Virginia

Status: Completed

Conditions: Smoking Cessation

Treatments: Drug: Pharmacological; Behavioral: Motivational Interviewing; Behavioral: Rate Reduction; Behavioral: Brief Advice; Behavioral: MI+RR

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02905656

15-04215-XP 0027114

1R01CA193245-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 903 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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903 participants in 4 patient groups, including a placebo group

Brief Advice

Placebo Comparator group

Description:

Participants will receive brief advice to quit smoking, and be provided psycho-education citing health consequences and the positive impact on mortality and morbidity.

Treatment:

Behavioral: Brief Advice

Motivational Interviewing (MI)

Experimental group

Description:

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.

Treatment:

Behavioral: Motivational Interviewing

Rate Reduction (RR)

Experimental group

Description:

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.

Treatment:

Behavioral: Rate Reduction

Drug: Pharmacological

MI + RR

Experimental group

Description:

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.

Treatment:

Behavioral: MI+RR

Drug: Pharmacological