The purpose of this Pilot feasibility study is to find out the effect of different behavioral treatments along with different duration of a drug called varenicline, on smoking behavior and quitting smoking. Varenicline, also known as Chantix™, is an FDA-approved medication that has been shown to help people quit smoking.
Following the initial telephone screening, eligible participants will be scheduled for a screening evaluation session. Following the screening evaluation, participants who pass the medical screening and meet all other inclusion criteria will be scheduled for their first assessment and then randomized to receive standard varenicline (SV), extended varenicline (EV), or extended varenicline plus facilitated extinction (EV + FE). The randomization list will be generated by the study statistician. It will be stratified by gender and will employ a variable block randomization that will guarantee that the arms are balanced when a given block is filled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
86
All participants will take the following dose of varenicline: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day through week 16 of the study. Arm descriptions show specific details for each group.
Counseling and support materials (including a review and self-monitoring workbook tentatively titled, Winding Down: A Guide to Quitting Smoking using Varenicline) instructing participants to systematically utilize the FE techniques provided.
The first laboratory assessment will consist of completion of questionnaires and a cue-reactivity test. The second laboratory assessment will be scheduled for the end of the week before the participant's quit date. It will involve completion of questionnaires and another cue reactivity test. A follow-up session conducted by research staff will occur one month after the target quit date to collect information about each participant's current smoking status, smoking rate, varenicline use, and opinion about the treatment. A second follow-up session will be conducted by telephone and will occur three months after the target quit date, at the end of varenicline use. At the end of the study, participants will be asked to complete a brief survey asking basic information, similar to the questions during the screening period.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Rate of Participant Retention
Practicality: Number of participants completing 3 month post treatment follow-up. Feasibility: Ability to recruit and retain sufficient numbers of the target population, which would be essential in conducting a future randomized clinical trial (RCT).
Time frame: End of post treatment follow-up period of 3 months - approximately 28 weeks
Client Satisfaction Questionnaire (CSQ) Results
Acceptability: Mean score of Client Satisfaction Questionnaire (CSQ) version 8 by Attkison \& Greenfield. Questionnaire scores client satisfaction with a scale of 1-4 per question, 1 being very dissatisfied and 4 being very satisfied. Score total range is 8-32. A total score of 32 would be the highest possible Client Satisfaction Score.
Time frame: One month post treatment - approximately 20 weeks
Rate of Intervention Adherence - Medication
Percent of participants still using varenicline at time of analysis.
Time frame: One month post treatment - approximately 20 weeks
Average Intervention Adherence - Cigarettes Per Day (CPD)
Average Cigarettes per Day across group, during last week of treatment.
Time frame: During last week of treatment, week 16
Mean Peak Craving Score Per Group
Peak craving per day by treatment group, scored using an 11-point Likert scale 0-10. 0 was "none", 5 "medium" and 10 "very high/strong"
Time frame: Across 4 pre-quit weeks
Mean Smoking Satisfaction Score Per Group
Smoking satisfaction per day by treatment group, using 11-point Likert scale, 0-10. 0 was "none", 5 "medium" and 10 "very high"
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Time frame: Across 4 pre-quit weeks