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| Name | Class |
|---|---|
| James and Esther King Biomedical Research Program | OTHER |
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended Varenicline + Facilitated Extinction | Active Comparator | Extended Varenicline plus Facilitated Extinction (EV+FE). Participants in the EV+FE condition will receive varenicline for a 4-week run-in period while continuing to smoke. In addition, the EV+FE condition will receive 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. All groups will undergo periodic laboratory assessments and surveys. |
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| Standard Varenicline (SV) | Active Comparator | Participants in the Standard Varenicline (SV) condition will receive varenicline for the usual 1-week run-in period while continuing to smoke. All groups will undergo periodic laboratory assessments and surveys. |
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| Extended Varenicline (EV) | Active Comparator | Participants in the Extended Varenicline (EV) condition will receive varenicline for a 4-week run-in period while continuing to smoke. All groups will undergo periodic laboratory assessments and surveys. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | End of post treatment follow-up period of 3 months - approximately 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One month post treatment - approximately 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Brandon, Ph.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Extended Varenicline + Facilitated Extinction | Active Comparator: Extended Varenicline + Facilitated Extinction. |
| FG001 | Standard Varenicline | Active Comparator: Standard Varenicline (SV). |
| FG002 | Extended Varenicline | Active Comparator: Extended Varenicline (EV). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Extended Varenicline + Facilitated Extinction | Active Comparator: Extended Varenicline + Facilitated Extinction. |
| BG001 | Standard Varenicline | Active Comparator: Standard Varenicline (SV). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | All participants who completed 3 month post treatment follow up, regardless of study arm | Posted | Count of Participants | Participants | End of post treatment follow-up period of 3 months - approximately 28 weeks |
|
15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Extended Varenicline + Facilitated Extinction | Active Comparator: Extended Varenicline + Facilitated Extinction. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Disorders - Other | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Brandon | H. Lee Moffitt Cancer Center and Research Institute | 813-745-1750 | thomas.brandon@moffitt.org |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Counseling and Support Materials | Other | 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. |
|
| Laboratory Assessments | Other | 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. |
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| Rate of Intervention Adherence - Medication | Percent of participants still using varenicline at time of analysis. | 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. | 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" | 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" | Across 4 pre-quit weeks |
| Declined before randomization |
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| Auto accident |
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| BG002 | Extended Varenicline | Active Comparator: Extended Varenicline (EV). |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
All participants who received Standard Varenicline (SV)
| OG002 | Extended Varenicline | All participants who received Extended Varenicline |
|
|
| 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. | Posted | Mean | Full Range | units on a scale | One month post treatment - approximately 20 weeks |
|
|
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| Secondary | Rate of Intervention Adherence - Medication | Percent of participants still using varenicline at time of analysis. | All participants. | Posted | Number | percentage of participants | One month post treatment - approximately 20 weeks |
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| Secondary | Average Intervention Adherence - Cigarettes Per Day (CPD) | Average Cigarettes per Day across group, during last week of treatment. | All participants. | Posted | Mean | Standard Deviation | cigarettes per day | During last week of treatment, week 16 |
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| 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" | All participants. | Posted | Mean | Standard Error | units on a scale | Across 4 pre-quit weeks |
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| 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" | All participants. | Posted | Mean | Standard Error | units on a scale | Across 4 pre-quit weeks |
|
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| 0 |
| 19 |
| 1 |
| 19 |
| 0 |
| 19 |
| EG001 | Standard Varenicline | Active Comparator: Standard Varenicline (SV). | 0 | 20 | 1 | 20 | 0 | 20 |
| EG002 | Extended Varenicline | Active Comparator: Extended Varenicline (EV). | 0 | 19 | 0 | 19 | 0 | 19 |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Esophageal Ulcer | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Gallblader Pain | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
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| Vascular access complication | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
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| Joint range of motion decreased lumbar spine | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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| D001523 |
| Mental Disorders |
| D011810 | Quinoxalines |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |