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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA038076-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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The investigators' goal is to identify the most appropriate smoking cessation treatments for smokers based on genetic information. Smokers try to quit smoking but relapses are common.
The investigators' goal is to determine whether genetic markers can be used to optimize smoking cessation pharmacotherapy to enhance efficacy, medication adherence, and reduce side effects. Smoking is a leading cause of preventable death and disability, and smoking cessation reverses the risk of mortality. However, cessation failure is common despite available cessation medications, which are associated with different efficacy, side effects, adherence, use constraints, and costs. This challenge can be addressed by improving current treatments via personalized medicine based on individual genetic markers to maximize efficacy and minimize side effects.
The investigators propose a prospective, genotype-based stratified randomization trial to compare two smoking cessation medications (combination NRT [patch and lozenge], varenicline vs. placebo) for 3 months in 720 smokers with known genotypes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination NRT and Counseling | Active Comparator | Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment. |
|
| Varenicline (Chantix) and Counseling | Active Comparator | Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment. |
|
| Placebo Medicine and Counseling | Placebo Comparator | Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination NRT (Nicotine patch, Nicotine lozenge) | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 7-day Point Prevalence Quit Rate | The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Abstinence | The definition of this measure requires: Not taking even 1 cigarette puff from target quit date to end of treatment. | 12 weeks (with first 1 week initial grace period) |
| 7-day Point Prevalence Quit Rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li-Shiun Chen, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32602170 | Derived | Chen LS, Baker TB, Miller JP, Bray M, Smock N, Chen J, Stoneking F, Culverhouse RC, Saccone NL, Amos CI, Carney RM, Jorenby DE, Bierut LJ. Genetic Variant in CHRNA5 and Response to Varenicline and Combination Nicotine Replacement in a Randomized Placebo-Controlled Trial. Clin Pharmacol Ther. 2020 Dec;108(6):1315-1325. doi: 10.1002/cpt.1971. Epub 2020 Aug 4. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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-The study consented 894 participants and 72 were excluded after consenting due to no longer wanting to participate or not meeting all the eligibility criteria prior to randomization. The 72 were not considered enrolled in the study per the policy of the institution.
The study opened to participant enrollment on 05/20/2015 and closed to participant enrollment on 07/23/2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Combination NRT and Counseling | Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment. |
| FG001 | Varenicline (Chantix) and Counseling | Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment. |
| FG002 | Placebo Medicine and Counseling | Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Combination NRT and Counseling | Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment. |
| BG001 |
| 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 Quit Rate | The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence. | Posted | Count of Participants | Participants | Week 12 |
|
Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
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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 | Combination NRT and Counseling | Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Li-Shiun Chen, M.D. | Washington University School of Medicine | 314-362-3932 | li-shiun@wustl.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 | Feb 12, 2019 | Dec 20, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 26, 2019 | Dec 20, 2019 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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Not provided
| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Varenicline | Drug |
|
|
| Placebo | Drug |
|
| Intensive smoking counseling | Behavioral |
|
The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence.
| Week 24 |
| Number of Days to Lapse |
| Assessed from the target quit day through 52 weeks |
| Number of Days to Relapse |
| Assessed from the target quit day through 52 weeks |
| Initial Cessation | Defined as at least 1 day of abstinence during the first 7 days after the target quit day. | Assessed for the first seven days after the target quit date |
| Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | -The definition of this measure requires; no self-reported smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment. | 0-52 Weeks |
| Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | The definition of this measure requires self-reported cigarettes per day. | 0-52 Weeks |
| Medication Adherence | Adherence is the proportion of expected medication (varenicline, patch, lozenge) taken as advised during pre-quit week to week 12 | Pre-quit week to Week 12 |
| Side Effects | All reported side effects (occurring>4%) will be summarized and presented for the study. In addition, the investigators will further identify a pre-specified set of key side effects as being related to drug agonist effects (e.g., nausea, vomiting, racing heart, headache, and sleep disturbance). These will be analyzed as rate of occurrence during the period of medication use. | Pre-quit week to Week 12 |
| Withdrawal |
| Pre-quit, quit, week 1, week 2, and week 4 |
| Varenicline (Chantix) and Counseling |
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment. |
| BG002 | Placebo Medicine and Counseling | Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Placebo Medicine and Counseling | Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment. |
|
|
| Secondary | Continuous Abstinence | The definition of this measure requires: Not taking even 1 cigarette puff from target quit date to end of treatment. | Posted | Count of Participants | Participants | 12 weeks (with first 1 week initial grace period) |
|
|
|
| Secondary | 7-day Point Prevalence Quit Rate | The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence. | Posted | Count of Participants | Participants | Week 24 |
|
|
|
| Secondary | Number of Days to Lapse |
| 26 participants in Combination NRT & Counseling, 19 participants in Varenicline (Chantix) & Counseling, & 16 participants in Placebo Medicine & Counseling did not lapse by the end of the 52 weeks. 4 participants in Combination NRT & Counseling, 9 participants in Varenicline (Chantix) & Counseling, & 5 participants had missing information on lapse. | Posted | Mean | Standard Error | days | Assessed from the target quit day through 52 weeks |
|
|
|
| Secondary | Number of Days to Relapse |
| 76 participants in Combination NRT & Counseling, 66 participants in Varenicline (Chantix) & Counseling, & 51 participants in Placebo Medicine & Counseling did not relapse by the end of 52 weeks. 4 participants in Combination NRT & Counseling, 9 participants in Varenicline (Chantix) & Counseling, & 5 participants had missing information on relapse | Posted | Mean | Standard Error | days | Assessed from the target quit day through 52 weeks |
|
|
|
| Secondary | Initial Cessation | Defined as at least 1 day of abstinence during the first 7 days after the target quit day. | Posted | Count of Participants | Participants | Assessed for the first seven days after the target quit date |
|
|
|
| Secondary | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | -The definition of this measure requires; no self-reported smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment. | Participants who had missing data are not included in the number of participants analyzed | Posted | Count of Participants | Participants | 0-52 Weeks |
|
|
|
| Secondary | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | The definition of this measure requires self-reported cigarettes per day. | Participants who had missing data are not included in the number of participants analyzed | Posted | Mean | Standard Error | cigarettes per day | 0-52 Weeks |
|
|
|
| Secondary | Medication Adherence | Adherence is the proportion of expected medication (varenicline, patch, lozenge) taken as advised during pre-quit week to week 12 | Not all participants were evaluable for this outcome measure due to data not being available. Also the Varenicline (Chantix) and Counseling Arm did not receive the lozenge or the patch. The Combination NRT and Counseling Arm did not receive Varenicline (Chantix) | Posted | Mean | Standard Deviation | proportion of expected medication taken | Pre-quit week to Week 12 |
|
|
|
| Secondary | Side Effects | All reported side effects (occurring>4%) will be summarized and presented for the study. In addition, the investigators will further identify a pre-specified set of key side effects as being related to drug agonist effects (e.g., nausea, vomiting, racing heart, headache, and sleep disturbance). These will be analyzed as rate of occurrence during the period of medication use. | Not all participants were evaluable for this outcome measure due to data not being available. | Posted | Count of Participants | Participants | No | Pre-quit week to Week 12 |
|
|
|
| Secondary | Withdrawal |
| Not all participants were evaluable for this outcome measure due to data not being available. | Posted | Mean | Standard Deviation | score on a scale | Pre-quit, quit, week 1, week 2, and week 4 |
|
|
|
| 3 |
| 275 |
| 23 |
| 275 |
| 193 |
| 275 |
| EG001 | Varenicline (Chantix) and Counseling | Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment. | 2 | 274 | 17 | 274 | 204 | 274 |
| EG002 | Placebo Medicine and Counseling | Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment. | 4 | 273 | 27 | 273 | 175 | 273 |
| Death due to cardiorespiratory arrest | Cardiac disorders | Systematic Assessment |
|
| Death due to congestive heart failure | Cardiac disorders | Systematic Assessment |
|
| Heart failure | Cardiac disorders | Systematic Assessment |
|
| Left bundle branch block | Cardiac disorders | Systematic Assessment |
|
| Death due to diabetic coma | Endocrine disorders | Systematic Assessment |
|
| Diabetic ketoacidosis | Endocrine disorders | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | Systematic Assessment |
|
| Type 2 Diabetes | Endocrine disorders | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | Systematic Assessment |
|
| Diverticulosis | Gastrointestinal disorders | Systematic Assessment |
|
| Hemorrhoid | Gastrointestinal disorders | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Death, unknown | General disorders | Systematic Assessment |
|
| Death due to natural causes | General disorders | Systematic Assessment |
|
| Ammonia poisoning of liver | Hepatobiliary disorders | Systematic Assessment |
|
| Antibiotic spacer for MRSA infection in knee | Infections and infestations | Systematic Assessment |
|
| Cellulitis, right hand | Infections and infestations | Systematic Assessment |
|
| Ear infection | Infections and infestations | Systematic Assessment |
|
| Surgical incision site infection (post-surgery) | Infections and infestations | Systematic Assessment |
|
| Infection of second toe on left foot | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| MRSA infection in knee | Infections and infestations | Systematic Assessment |
|
| Malaria | Infections and infestations | Systematic Assessment |
|
| Severe sinus infection | Infections and infestations | Systematic Assessment |
|
| Severe tooth infection | Infections and infestations | Systematic Assessment |
|
| Broken arm | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Broken collarbone | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Broken ribs | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cervical disc fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Complication from gastric bypass surgery | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Death due to heroin overdose | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Gunshot wound | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Homicide by gunshot | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Motor vehicle accident (injury of intervertebral discs T10-12) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Partial amputation of leg due to MRSA infection | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Struck by vehicle | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Sternum fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Inter-vertebral dis herniation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Death due to Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Death due to brain tumor complications | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Lung cancer (stage 4) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Bell's palsy | Nervous system disorders | Systematic Assessment |
|
| Multiple sclerosis | Nervous system disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Alcohol dependence | Psychiatric disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Bipolar depression | Psychiatric disorders | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | Systematic Assessment |
|
| Unspecified mood disorder | Psychiatric disorders | Systematic Assessment |
|
| Death due to kidney failure | Renal and urinary disorders | Systematic Assessment |
|
| Kidney stone | Renal and urinary disorders | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Stage 4 endometriosis | Reproductive system and breast disorders | Systematic Assessment |
|
| Asthmatic episode | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chronic sinus necrosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Thoracic outlet syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Trouble breathing due to COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Abdominal hysterectomy due to endometriosis | Surgical and medical procedures | Systematic Assessment |
|
| Foot surgery to fix broken toes on right foot | Surgical and medical procedures | Systematic Assessment |
|
| Hip replacement surgery | Surgical and medical procedures | Systematic Assessment |
|
| Hysterectomy due to cervical cancer | Surgical and medical procedures | Systematic Assessment |
|
| Hysterectomy due to enlarged fallopian tubes | Surgical and medical procedures | Systematic Assessment |
|
| Knee surgery for osteoarthritis | Surgical and medical procedures | Systematic Assessment |
|
| Left knee replacement | Surgical and medical procedures | Systematic Assessment |
|
| Minor procedure to clean wound on right foot | Surgical and medical procedures | Systematic Assessment |
|
| Surgery for aortic valve stenosis and cardiac bypass | Surgical and medical procedures | Systematic Assessment |
|
| Urethral sling surgery due to urinary incontinence | Surgical and medical procedures | Systematic Assessment |
|
| Abdominal aortic aneurysm | Vascular disorders | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Pulmonary embolism | Vascular disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Rapid, slow, pounding, or irregular heartbeat | Cardiac disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Vivid dreams | Psychiatric disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Weakness | General disorders | Systematic Assessment |
|
| Sweating | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Itching/hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Swelling in face or hands | Immune system disorders | Systematic Assessment |
|
| Swelling or tingling in mouth or throat | Immune system disorders | Systematic Assessment |
|
| Mouth problems (e.g. pain or sore) | Gastrointestinal disorders | Systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chest tightness | Cardiac disorders | Systematic Assessment |
|
| Trouble breathing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Feeling worried, nervous, scared, or anxious | Psychiatric disorders | Systematic Assessment |
|
| Feeling panicky or having panic attacks | Psychiatric disorders | Systematic Assessment |
|
| Feeling agitated and restless | Psychiatric disorders | Systematic Assessment |
|
| Feeling hostile or angry towards others | Psychiatric disorders | Systematic Assessment |
|
| Feeling significantly down, depressed, or hopeless | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011810 | Quinoxalines |
|
| 1 week - Abstinence |
|
|
| 2 week - Abstinence |
|
|
| 4 week - Abstinence |
|
|
| 12 week - Abstinence |
|
|
| 26 week - Abstinence |
|
|
| 52 week - Abstinence |
|
|
|
| 1 week |
|
|
| 2 week |
|
|
| 4 week |
|
|
| 12 week |
|
|
| 26 week |
|
|
| 52 week |
|
|
| Lozenge |
|
|
| Varenicline (Chantix) |
|
|
| Title | Measurements |
|---|---|
|
| Racing Heart |
|
| Headache |
|
| Sleep Disturbance |
|
|
| Concentration |
|
| Craving |
|
| Hunger |
|
| Sadness |
|
| Sleep |
|