Overview

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

Status:
Completed
Trial end date:
2020-06-16
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Tennessee
University of Virginia
Collaborators:
National Cancer Institute (NCI)
University of Tennessee
Treatments:
Nicotine
Criteria
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