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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA044125 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Los Angeles Clinical Trials | UNKNOWN |
| University of Nevada, Reno | OTHER |
| Pfizer |
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The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
Given the recent research on varenicline showing that it is more effective than nicotine patch and bupropion, and with the removal of the box warning, research is needed to assess whether smokers can use varenicline without a prescription and formal behavioral support. To test this, the primary goal of the proposed research is to test whether varenicline is a candidate for switching from prescription (Rx) to OTC, and whether a dose lower than that currently approved is as effective in an OTC environment. To understand the within-person mechanisms explaining how and when OTC varenicline might improve cessation outcomes, the investigators also propose to assess experience with OTC varenicline via (a) ecological momentary assessment (EMA).
Primary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.0mg varenicline b.i.d. | Experimental | Days 1 through 3: 0.5mg, once daily; days 4 through 7: 0.5mg, twice daily; days 8 through end of treatment: 1mg, twice daily. |
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| 0.5mg varenicline b.i.d. | Experimental | Days 1 through 3: 0.5mg, once daily; 0.5 mg b.i.d. dose starting at day 4 through the end of the study |
|
| 0.0mg placebo varenicline b.i.d. | Placebo Comparator | Days 1 through 3: 0.0mg placebo once daily; days 4 through 7: 0.0mg placebo twice daily; days 8 through end of treatment: 0.0 mg placebo twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1.0mg Varenicline b.i.d. | Drug | Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Who Have Continuous Abstinence as Verified by Breath Carbon Monoxide or Urine Cotinine | Participants will provide self reported smoking status that has been verified by breath carbon monoxide or cotinine - Continuous abstinence | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Breath Carbon Monoxide or Urine Cotinine Verified Abstinence From Smoking Cigarettes - Point Prevalence Abstinence | Participants will provide self reported smoking status that has been verified by breath carbon monoxide or cotinine - point prevalence abstinence | Week 12 visit |
| Breath Carbon Monoxide Verified Abstinence From Smoking Cigarettes |
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Inclusion Criteria for the In-person Cohort
Exclusion Criteria for the In-person Cohort
Acceptable methods of birth control include abstinence, oral contraceptives, the contraceptive patch, the contraceptive ring, and condoms.
Inclusion Criteria for the Remote Cohort
10. Must own study compatible smart-phone (iPhone or Android) 11. Must be a current resident of the United States
Exclusion Criteria for the Remote Cohort
Acceptable methods of birth control include abstinence, oral contraceptives, the contraceptive patch, the contraceptive ring, and condoms.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Phoenix | Arizona | 85004 | United States | ||
| Los Angeles Clinical Trials |
While the exact process is unclear, when all data have been locked and investigators have published what they choose, de-identified data will be made available for the duration that we are required by NIH to maintain the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1.0mg Varenicline b.i.d. | Days 1 through 3: 0.5mg, once daily; days 4 through 7: 0.5mg, twice daily; days 8 through end of treatment: 1mg, twice daily. 1.0mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype. |
| FG001 | 0.5mg Varenicline b.i.d. | Days 1 through 3: 0.5mg, once daily; 0.5 mg b.i.d. dose starting at day 4 through the end of the study 0.5mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype. |
| FG002 | 0.0mg Placebo Varenicline b.i.d. | Days 1 through 3: 0.0mg placebo once daily; days 4 through 7: 0.0mg placebo twice daily; days 8 through end of treatment: 0.0 mg placebo twice daily. 0.0mg placebo Varenicline b.i.d.: Product that looks like active varenicline, but contains no active ingredient |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1.0mg Varenicline b.i.d. | Days 1 through 3: 0.5mg, once daily; days 4 through 7: 0.5mg, twice daily; days 8 through end of treatment: 1mg, twice daily. 1.0mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype. |
| 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 | The Number of Participants Who Have Continuous Abstinence as Verified by Breath Carbon Monoxide or Urine Cotinine | Participants will provide self reported smoking status that has been verified by breath carbon monoxide or cotinine - Continuous abstinence | Posted | Count of Participants | Participants | Week 12 |
|
Adverse events were measured in relation to the baseline at weeks 2, 4, 8, 12, 13 and 26.
No different
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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 | 1.0mg Varenicline b.i.d. | Days 1 through 3: 0.5mg, once daily; days 4 through 7: 0.5mg, twice daily; days 8 through end of treatment: 1mg, twice daily. 1.0mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma Attack | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
Note that the study was interrupted because of COVID.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Leischow, PhD | Arizona State University | 602-496-3300 | scott.leischow@asu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2021 | Sep 10, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D013375 | Substance Withdrawal Syndrome |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| INDUSTRY |
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| 0.5mg Varenicline b.i.d. | Drug | Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype. |
|
| 0.0mg placebo Varenicline b.i.d. | Drug | Product that looks like active varenicline, but contains no active ingredient |
|
Participants who self report not smoking will be asked to have smoking status verified by breath carbon monoxide |
| Week 26 |
| Burbank |
| California |
| 91505 |
| United States |
| BG001 | 0.5mg Varenicline b.i.d. | Days 1 through 3: 0.5mg, once daily; 0.5 mg b.i.d. dose starting at day 4 through the end of the study 0.5mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype. |
| BG002 | 0.0mg Placebo Varenicline b.i.d. | Days 1 through 3: 0.0mg placebo once daily; days 4 through 7: 0.0mg placebo twice daily; days 8 through end of treatment: 0.0 mg placebo twice daily. 0.0mg placebo Varenicline b.i.d.: Product that looks like active varenicline, but contains no active ingredient |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | One person did not identify their sex, though we have all of the rest of their information. Thus, we actually have 104 participants in the 1.0 mg condition, but could only show 103 when reporting sex | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Days 1 through 3: 0.5mg, once daily; 0.5 mg b.i.d. dose starting at day 4 through the end of the study
0.5mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.
| OG002 | 0.0mg Placebo Varenicline b.i.d. | Days 1 through 3: 0.0mg placebo once daily; days 4 through 7: 0.0mg placebo twice daily; days 8 through end of treatment: 0.0 mg placebo twice daily. 0.0mg placebo Varenicline b.i.d.: Product that looks like active varenicline, but contains no active ingredient |
|
|
| Secondary | Breath Carbon Monoxide or Urine Cotinine Verified Abstinence From Smoking Cigarettes - Point Prevalence Abstinence | Participants will provide self reported smoking status that has been verified by breath carbon monoxide or cotinine - point prevalence abstinence | Posted | Count of Participants | Participants | Week 12 visit |
|
|
|
| Secondary | Breath Carbon Monoxide Verified Abstinence From Smoking Cigarettes | Participants who self report not smoking will be asked to have smoking status verified by breath carbon monoxide | Posted | Count of Participants | Participants | Week 26 |
|
|
|
| 0 |
| 104 |
| 0 |
| 104 |
| 49 |
| 104 |
| EG001 | 0.5mg Varenicline b.i.d. | Days 1 through 3: 0.5mg, once daily; 0.5 mg b.i.d. dose starting at day 4 through the end of the study 0.5mg Varenicline b.i.d.: Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype. | 0 | 104 | 0 | 104 | 43 | 104 |
| EG002 | 0.0mg Placebo Varenicline b.i.d. | Days 1 through 3: 0.0mg placebo once daily; days 4 through 7: 0.0mg placebo twice daily; days 8 through end of treatment: 0.0 mg placebo twice daily. 0.0mg placebo Varenicline b.i.d.: Product that looks like active varenicline, but contains no active ingredient | 0 | 105 | 2 | 105 | 35 | 105 |
| Stab Wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Participant was stabbed in the community, and survived. |
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| Insomnia | General disorders | MedDRA | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Vivid Dreams | General disorders | MedDRA | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| D001519 | Behavior |
| Male |
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| African-American |
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| Asian |
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| AI/AN |
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| Other |
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| Missing |
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