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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).
The sample will be hospitalized patients smoking at least 10 cigarettes/day prior to hospitalization. Intention to quit smoking will not be required for study participation. Using a double-blinded, placebo-controlled, randomized design, participants will receive varenicline (0.5 mg BID as tolerated) or placebo during their hospitalization (Part 1) and will continue their study medication (placebo or active drug) for 4 weeks post-hospitalization (Part 2). Abstinence status will be examined at 4 weeks post-hospitalization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Control | Placebo Comparator | Smoking cessation counseling with placebo comparator |
|
| Experimental: Varenicline | Active Comparator | Smoking cessation counseling with varenicline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoking cessation counseling | Behavioral | Counseling sessions provided by a trained smoking counselor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 7 Day Point Prevalence Abstinence From All Forms of Tobacco | Self report of being quit for 7 continuous days at the time of the 4-week follow-up survey confirmed by saliva cotinine or urine anabasine verification. | 4 weeks after beginning study |
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Inclusion Criteria:
Exclusion Criteria:
- Study exclusion criteria are: dementia or other brain injury precluding ability to participate; Alzheimer's Disease; Parkinson's Disease; Huntington's Disease; meningitis; seizure disorder of a sustained nature; delirium; brain surgery; drug and/or alcohol dependence; suicidal ideation; end-stage renal disease (i.e., on dialysis); hypertensive crisis; stroke; myocardial infarction (MI) with severe cardiac damage; pregnancy or breastfeeding; non-English speaking; complete homelessness; or currently engaged in tobacco treatment. Study staff will consult with clinical staff prior to approach for study enrollment. In cases of severe renal impairment (estimated creatinine clearance <30 mL/min), medical staff will consult with participants' physician to assess the appropriateness for study enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Judith J Prochaska, PhD, MPH | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital and Clinics | Stanford | California | 94305 | 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 | Control: Sugar Pill Without Any Active Medication | Smoking counseling, Placebo: Placebo comparator Interventions:
Smoking counseling: Counseling sessions provided by a trained smoking counselor during 1st day of study along with 28 day supply of placebo Placebo: Sugar pill without any active medication |
| FG001 | Experimental: Varenicline | Smoking counseling, Varenicline: Experimental Interventions:
Smoking counseling: Counseling sessions provided by trained smoking counselor during 1st day of study along with 28 day supply of varenicline Varenicline: Varenicline (an approved medication for smoking cessation) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control: Sugar Pill Without Any Active Medication | Smoking counseling, Placebo: Placebo comparator Interventions:
Smoking counseling: Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study Placebo: Sugar pill without any active medication |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 7 Day Point Prevalence Abstinence From All Forms of Tobacco | Self report of being quit for 7 continuous days at the time of the 4-week follow-up survey confirmed by saliva cotinine or urine anabasine verification. | Posted | Number | participants | 4 weeks after beginning study |
|
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assessed by self-report at every time point
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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 | Control: Sugar Pill Without Any Active Medication | Smoking counseling, Placebo: Placebo comparator Interventions:
Smoking counseling: Counseling sessions provided by a trained smoking counselor during 1st day of study along with 28 day supply of placebo Placebo: Sugar pill without any active medication |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leg amputation | Musculoskeletal and connective tissue disorders | Leg amputation | Systematic Assessment | This was a planned re-hospitalization for a follow-up surgical procedure. Participant reported finishing his 4-week course of study medication on the day prior to re-hospitalization. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Prochaska | Stanford University | 6507243608 | jodi.prochaska@stanford.edu |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000073893 | Sugars |
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Drug | Sugar pill without any active medication |
|
|
| Varenicline | Drug | Varenicline (an approved medication for smoking cessation) |
|
|
| BG001 | Experimental: Varenicline | Smoking counseling, Varenicline: Experimental Interventions:
Smoking counseling: Counseling sessions provided by trained smoking counselor along with varenicline Varenicline: Varenicline (an approved medication for smoking cessation) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Smoking counseling, Varenicline: Experimental
Interventions:
Smoking counseling: Counseling sessions provided by trained smoking counselor along with varenicline
Varenicline: Varenicline (an approved medication for smoking cessation)
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Experimental: Varenicline | Smoking counseling, Varenicline: Experimental Interventions:
Smoking counseling: Counseling sessions provided by trained smoking counselor during 1st day of study along with 28 day supply of varenicline Varenicline: Varenicline (an approved medication for smoking cessation) | 2 | 9 | 0 | 9 |
|
| Renal disorder | Renal and urinary disorders | Renal disorder | Systematic Assessment | This adverse event occurred after the participant was scheduled to finish the 4 week course of of study medication. Participant was unable to recall whether taking study medication when the onset of the events described in the narrative occurred. |
|
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| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |