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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA030992-01 | U.S. NIH Grant/Contract | View source |
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Study has been put on clinical hold by FDA
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| Name | Class |
|---|---|
| FORUM Pharmaceuticals Inc | INDUSTRY |
| National Institute on Drug Abuse (NIDA) | NIH |
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This study is designed to evaluate the initial evidence for efficacy of the investigational medicine, EVP-6124, to improve smoking cessation outcomes with and without a standard taper of nicotine replacement therapy (NRT) in healthy nicotine dependent smokers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVP-6124 + NicoDerm (Active) | Experimental | One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days) |
|
| Placebo + NicoDerm (Active) | Active Comparator | One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days) |
|
| EVP-6124 + NRT Patch (Placebo) | Experimental | One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days) |
|
| Placebo + NRT Patch (Placebo) | Placebo Comparator | One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVP-6124 | Drug | One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effects of EVP-6124 on 7-day Point-prevalence Smoking Abstinence | Smoking abstinence is defined as a self-report of smoking no cigarettes for the past 7 days by time-line follow-back, confirmed by expired carbon monoxide (CO) <10 ppm and/or urine cotinine <50 ng/mL. | Week 1, 2, 4, 6, 8, 10, 12 |
| Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point | CO concentration was measured at every visit. | Baseline, Weeks 1, 2, 4, 6, 8, 10, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of EVP-6124 on Cognitive Performance as Measured by the Continuous Performance Test Hit Reaction Time | The Continuous Performance Test (CPT) is a measure of both vigilance/attentional control and response inhibition. During the task, subjects are required to press a button whenever a letter appears on the screen unless that letter is an 'X'. Measures of attentional control will serve as primary measure from this test. Baseline attentional impairment is associated with reduced odds of abstinence, abstinence differentially worsens performance on this measure in those with baseline attentional impairment, and NRT improves performance on a similar measure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Eden Evins, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Maurizio Fava, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Prior to initiation of any study procedures, the informed consent process was conducted by a study physician who explained the study in detail making sure that the subject understood the potential risks/benefits as outlined in the consent form; 350 signed consent, 60 were found ineligible and 130 either withdrew consent or was discontinued
Subjects were recruited using advertisements in the local media market.Those who made contact in response to advertisements spoke initially with a research coordinator who provided further information about the study, answered initial questions from the potential subject, and administered a 10-minute questionnaire assessing eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | EVP-6124 + NicoDerm (Active) | One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days) EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo Capsule | Drug | One placebo capsule ingested orally daily for 12 weeks (84 days) |
|
| NicoDerm Patch (Active) | Drug | One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6). |
|
| NRT Patch (Placebo) | Drug | One NRT patch (Placebo) daily for first 6 weeks (42 days). |
|
| Brief Supportive and Behavioral Treatment | Behavioral | Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. |
|
| Baseline, week 1, week 12 |
| Safety and Tolerability of EVP-6124 Alone or Combined With NRT | All AEs (adverse experiences) spontaneously reported by subjects and/or observed by investigator and evaluation of physical examinations, prior and concomitant medications, clinical laboratory tests, ECGs, and vital signs measurements. Data was collected at every visit and was analyzed as aggregate at the end of week 12 | Weeks 1-12 |
| Effects of EVP-6124 on Working Memory as Measured by the N-Back Task Reaction Time | This task is a standard measure that can assess working memory performance under varying levels of task demand. Subjects are presented with a stream of stimuli, and the task is to decide for each stimulus whether it matches the one presented N items before. The processing load can be varied systematically by manipulating the value of N, which is expressed with changes in accuracy and reaction time. The number of errors as well as reaction times increase monotonically with increasing levels of N. The n-back task is sensitive to nicotine administration and abstinence effects. Here we present reaction time (RT) | Baseline, week 1, week 12 |
| FG001 | EVP-6124 + NRT Patch (Placebo) | One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days) EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) NRT (nicotine replacement therapy) Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. |
| FG002 | Placebo + NicoDerm (Active) | One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days) Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days) NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. |
| FG003 | Placebo + NRT Patch (Placebo) | One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days) Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days) NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | EVP-6124 + NicoDerm (Active) | One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days) EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. |
| BG001 | EVP-6124 + NRT Patch (Placebo) | One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days) EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. |
| BG002 | Placebo + NicoDerm (Active) | One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days) Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days) NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. |
| BG003 | Placebo + NRT Patch (Placebo) | One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days) Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days) NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Years of Regular Smoking | Mean | Standard Deviation | years |
| |||||||||||||||
| Cigarettes Smoked Per Day | Mean | Standard Deviation | cigarettes per day |
| |||||||||||||||
| Expired CO, ppm | Measurements of CO in expired breath was the primary means of biochemical verification of smoking self-report during the study at each study visit. End-expiratory CO levels ≥10 ppm indicate current cigarette use, whereas levels of <10 ppm indicate abstinence. | Mean | Standard Deviation | parts per million |
| ||||||||||||||
| FTND Score | Fagerström Test for Nicotine Dependence (FTND) will determine the level of nicotine dependence. The scale score ranges from 0 to 10. An FTND score ≥6 indicates high nicotine dependence and a score of <6 indicates a low to moderate level of dependence | Mean | Standard Deviation | units on a scale |
|
| 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 | Effects of EVP-6124 on 7-day Point-prevalence Smoking Abstinence | Smoking abstinence is defined as a self-report of smoking no cigarettes for the past 7 days by time-line follow-back, confirmed by expired carbon monoxide (CO) <10 ppm and/or urine cotinine <50 ng/mL. | The primary smoking cessation variable is biochemically verified self-report of 7-day point prevalence abstinence at 12 weeks (end of treatment). | Posted | Number | % participants with 7-Day Point Prevalen | Week 1, 2, 4, 6, 8, 10, 12 |
|
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| |||||||||||||||||||||||||||||||||||
| Primary | Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point | CO concentration was measured at every visit. | Posted | Mean | Standard Deviation | part per million | Baseline, Weeks 1, 2, 4, 6, 8, 10, 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Effects of EVP-6124 on Cognitive Performance as Measured by the Continuous Performance Test Hit Reaction Time | The Continuous Performance Test (CPT) is a measure of both vigilance/attentional control and response inhibition. During the task, subjects are required to press a button whenever a letter appears on the screen unless that letter is an 'X'. Measures of attentional control will serve as primary measure from this test. Baseline attentional impairment is associated with reduced odds of abstinence, abstinence differentially worsens performance on this measure in those with baseline attentional impairment, and NRT improves performance on a similar measure. | Posted | Mean | Standard Deviation | mili seconds | Baseline, week 1, week 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Safety and Tolerability of EVP-6124 Alone or Combined With NRT | All AEs (adverse experiences) spontaneously reported by subjects and/or observed by investigator and evaluation of physical examinations, prior and concomitant medications, clinical laboratory tests, ECGs, and vital signs measurements. Data was collected at every visit and was analyzed as aggregate at the end of week 12 | Posted | Count of Participants | Participants | Weeks 1-12 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Effects of EVP-6124 on Working Memory as Measured by the N-Back Task Reaction Time | This task is a standard measure that can assess working memory performance under varying levels of task demand. Subjects are presented with a stream of stimuli, and the task is to decide for each stimulus whether it matches the one presented N items before. The processing load can be varied systematically by manipulating the value of N, which is expressed with changes in accuracy and reaction time. The number of errors as well as reaction times increase monotonically with increasing levels of N. The n-back task is sensitive to nicotine administration and abstinence effects. Here we present reaction time (RT) | Posted | Mean | Standard Deviation | mili seconds | Baseline, week 1, week 12 |
|
week 1 to week 12
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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 | EVP-6124 + NicoDerm (Active) | One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days) EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. | 1 | 40 | 35 | 40 | ||
| EG001 | EVP-6124 + NRT Patch (Placebo) | One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days) EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. | 1 | 41 | 30 | 41 | ||
| EG002 | Placebo + NicoDerm (Active) | One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days) Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days) NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. | 1 | 38 | 34 | 38 | ||
| EG003 | Placebo + NRT Patch (Placebo) | One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days) Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days) NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. | 0 | 41 | 34 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Diverticulitis Flare | Gastrointestinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Elevated Creatine phosphokinase (CPK) | General disorders | Systematic Assessment |
| ||
| Depressive symptoms | Psychiatric disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Cold/flu | Infections and infestations | Systematic Assessment |
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| Skin Irritation at Patch Site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Stomach pain | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | General disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| weight gain | General disorders | Systematic Assessment |
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| Irritability | General disorders | Systematic Assessment |
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| Increase appetite | General disorders | Systematic Assessment |
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| Muscle spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Allergies | General disorders | Systematic Assessment |
| ||
| Abnormal sleeping pattern | General disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| A. Eden Evins, MD, MPH | Massachusetts General Hospital-Center for Addiction Medicine | 617-643-4679 | aeevins@mgh.harvard.edu |
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C573817 | 7-chloro-N-quinuclidin-3-yl-benzo(b)thiophene-2-carboxamide |
| D015444 | Exercise |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| African American |
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| Other |
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| Seven-Day Point Prevalence Abstinence Rate week 2 |
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| Seven-Day Point Prevalence Abstinence Rate week 4 |
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| Seven-Day Point Prevalence Abstinence Rate week 6 |
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| Seven-Day Point Prevalence Abstinence Rate week 8 |
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| Seven-Day Point Prevalence Abstinence Rate week 10 |
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| Seven-Day Point Prevalence Abstinence Rate week 12 |
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| Placebo + NicoDerm CQ (Active) |
One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days) Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days) NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. |
| OG003 | Placebo + NRT Patch (Placebo) | One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days) Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days) NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. |
|
|
| OG002 | Placebo + NicoDerm CQ (Active) | One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days) Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days) NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. |
| OG003 | Placebo + NRT Patch (Placebo) | One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days) Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days) NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. |
|
|
| OG002 | Placebo + NicoDerm CQ (Active) | One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days) Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days) NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. |
| OG003 | Placebo + NRT Patch (Placebo) | One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days) Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days) NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. |
|
|
| OG002 | Placebo + NicoDerm CQ (Active) | One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days) Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days) NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. |
| OG003 | Placebo + NRT Patch (Placebo) | One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days) Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days) NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days). Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association. |
|
|