Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02905656 |
| Other study ID # |
15-04215-XP 0027114 |
| Secondary ID |
1R01CA193245-01A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2016 |
| Est. completion date |
June 16, 2020 |
Study information
| Verified date |
February 2024 |
| Source |
University of Virginia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
