| ID | Type | Description | Link |
|---|---|---|---|
| Pfizer IIR-GA30523 |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.
This pilot study will utilize a two group randomized design. Adult smokers who are motivated to quit smoking will be randomized to one of two treatment groups. Both groups will receive brief support counseling. During a one-week baseline and the 4-week pre-quit period smoking rate, smoking satisfaction, withdrawal, and craving will be assessed on a daily basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varenicline | Experimental | drug plus counseling. |
|
| placebo | Active Comparator | placebo plus counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline | Drug | variable dosing schedule |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Smoking Behavior | Change in cigarettes per day from Week 2 to Week 5 | Change in cigarettes per day from Week 2 to Week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Smoking Cessation. | To parallel most clinical trials of varenicline, we focused on CO-verified (<11 parts per million) continuous abstinence (not even one puff) during the final 4 weeks of treatment (i.e., post-quit weeks 8 through 11). Participants lost to follow-up were coded as smokers. | 12 weeks after quit date. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin C Mahoney, MD, PhD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37142273 | Derived | Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Extended Run-In | The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment. |
| FG001 | Standard Run-In | The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks. Both groups received brief cognitive-behavioral counseling. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Extended Run-In | The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment. |
| BG001 | Standard Run-In | The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks. Both groups received brief cognitive-behavioral counseling. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in Smoking Behavior | Change in cigarettes per day from Week 2 to Week 5 | ITT | Posted | Mean | Standard Error | Change in Cigarettes Per Day | Change in cigarettes per day from Week 2 to Week 5 |
|
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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 Run-In | The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritability | Psychiatric disorders | Systematic Assessment | One participant in the Standard run-in arm who reported feelings of hostility and irritability 3 weeks after being started on varenicline |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Martin Mahoney | Roswell Park Cancer Institute | 7168452300 | martin.mahoney@roswellpark.org |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| placebo | Drug | placebo |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Baseline CPD | Mean | Standard Deviation | Cigarettes Per Day |
|
|
|
| Secondary | Rates of Smoking Cessation. | To parallel most clinical trials of varenicline, we focused on CO-verified (<11 parts per million) continuous abstinence (not even one puff) during the final 4 weeks of treatment (i.e., post-quit weeks 8 through 11). Participants lost to follow-up were coded as smokers. | ITT | Posted | Count of Participants | Participants | 12 weeks after quit date. |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 18 |
| 32 |
| EG001 | Standard Run-In | The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks. Both groups received brief cognitive-behavioral counseling. | 0 | 28 | 1 | 28 | 6 | 28 |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
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| D011810 | Quinoxalines |