Smoking Cessation, Tobacco Dependence
Conditions
Keywords
pharmacotherapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGVarenicline
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.
OTHERCounseling and Support Materials
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.
Sponsors
James and Esther King Biomedical Research Program
Pfizer
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ≥18 years of age * Smoke at least 10 cigarettes daily for the past year * Expired-air carbon monoxide (CO) \> 8 ppm * Medically eligible to receive varenicline * Score at least a 5 on the Contemplation Ladder (Biener & Abrams 1991), a measure of motivation to quit smoking.
Exclusion criteria
* Are pregnant or lactating * Have renal dysfunction * Have a history of seizures * Are medically at risk in the judgment of the study physician * Have ever used varenicline * Have used other smoking cessation medications within the past three months * Have current psychiatric disorders (i.e. major depression, bipolar, and/or psychotic disorders) * Have substance use disorder as determined by a psychiatric screener (Mini International Neuropsychiatric Interview \[MINI\]; Sheehan et al 2015). * We must limit the number of participants from the same street address to 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Participant Retention | End of post treatment follow-up period of 3 months - approximately 28 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Client Satisfaction Questionnaire (CSQ) Results | One month post treatment - approximately 20 weeks | 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. |
| Rate of Intervention Adherence - Medication | One month post treatment - approximately 20 weeks | Percent of participants still using varenicline at time of analysis. |
| Average Intervention Adherence - Cigarettes Per Day (CPD) | During last week of treatment, week 16 | Average Cigarettes per Day across group, during last week of treatment. |
| Mean Peak Craving Score Per Group | Across 4 pre-quit weeks | 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 |
| Mean Smoking Satisfaction Score Per Group | Across 4 pre-quit weeks | Smoking satisfaction per day by treatment group, using 11-point Likert scale, 0-10. 0 was none, 5 medium and 10 very high |
Countries
United States
Participant flow
Recruitment details
Daily cigarette smokers were recruited from the community for a smoking cessation intervention study, from July 2014 through August 2015, by Moffitt Cancer Center in Tampa, Florida.
Pre-assignment details
86 interested parties were consented, 1 later declined, 23 did not meet criteria. 62 were eligible, 3 discontinued due to factors unrelated to study, 1 failed to attend first assessment. 58 parties participated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Extended Varenicline + Facilitated Extinction Active Comparator: Extended Varenicline + Facilitated Extinction. | 19 |
| Standard Varenicline Active Comparator: Standard Varenicline (SV). | 20 |
| Extended Varenicline Active Comparator: Extended Varenicline (EV). | 19 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Auto accident | 1 | 0 | 0 |
| Overall Study | Cancer diagnosis | 0 | 0 | 1 |
| Overall Study | Declined before randomization | 1 | 0 | 0 |
| Overall Study | Moved from area | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Extended Varenicline + Facilitated Extinction | Standard Varenicline | Extended Varenicline | Total |
|---|---|---|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 50.5 | 51.9 years STANDARD_DEVIATION 11 | 48.4 years STANDARD_DEVIATION 11.4 | 50.5 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment United States | 19 participants | 20 participants | 19 participants | 58 participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 9 Participants | 25 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 10 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 20 | 0 / 19 |
| serious Total, serious adverse events | 1 / 19 | 1 / 20 | 0 / 19 |
Outcome results
Primary
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
Population: All participants who completed 3 month post treatment follow up, regardless of study arm
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended Varenicline + Facilitated Extinction | Rate of Participant Retention | 15 Participants |
| Standard Vareniclline | Rate of Participant Retention | 16 Participants |
| Extended Varenicline | Rate of Participant Retention | 19 Participants |
Secondary
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
Population: All participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended Varenicline + Facilitated Extinction | Average Intervention Adherence - Cigarettes Per Day (CPD) | 17.58 cigarettes per day | Standard Deviation 5.85 |
| Standard Vareniclline | Average Intervention Adherence - Cigarettes Per Day (CPD) | 14.95 cigarettes per day | Standard Deviation 9.06 |
| Extended Varenicline | Average Intervention Adherence - Cigarettes Per Day (CPD) | 11.05 cigarettes per day | Standard Deviation 6.16 |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Extended Varenicline + Facilitated Extinction | Client Satisfaction Questionnaire (CSQ) Results | 30.33 units on a scale |
| Standard Vareniclline | Client Satisfaction Questionnaire (CSQ) Results | 30.80 units on a scale |
| Extended Varenicline | Client Satisfaction Questionnaire (CSQ) Results | 30.47 units on a scale |
Secondary
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
Population: All participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended Varenicline + Facilitated Extinction | Mean Peak Craving Score Per Group | 4.64 units on a scale | Standard Error 0.56 |
| Standard Vareniclline | Mean Peak Craving Score Per Group | 6.34 units on a scale | Standard Error 0.49 |
| Extended Varenicline | Mean Peak Craving Score Per Group | 4.56 units on a scale | Standard Error 0.34 |
Secondary
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
Time frame: Across 4 pre-quit weeks
Population: All participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended Varenicline + Facilitated Extinction | Mean Smoking Satisfaction Score Per Group | 3.37 units on a scale | Standard Error 0.64 |
| Standard Vareniclline | Mean Smoking Satisfaction Score Per Group | 5.22 units on a scale | Standard Error 67 |
| Extended Varenicline | Mean Smoking Satisfaction Score Per Group | 2.59 units on a scale | Standard Error 0.4 |
Secondary
Rate of Intervention Adherence - Medication
Percent of participants still using varenicline at time of analysis.
Time frame: One month post treatment - approximately 20 weeks
Population: All participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended Varenicline + Facilitated Extinction | Rate of Intervention Adherence - Medication | 80 percentage of participants |
| Standard Vareniclline | Rate of Intervention Adherence - Medication | 80 percentage of participants |
| Extended Varenicline | Rate of Intervention Adherence - Medication | 84 percentage of participants |