| ID | Type | Description | Link |
|---|---|---|---|
| R01DA017441 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Adult smokers (21-65) and adolescent smokers (18 - 21) years of age residing in Alameda and Santa Clara counties will serve as the target population for this study. A total of 400 smokers meeting eligibility criteria will be randomized. Treatment will include both open label and extended treatment phases. Randomization. Participants will be randomized to extended therapy or control conditions at baseline (prior to open label treatment) and the analysis will be intention-to-treat (ITT) to avoid the threat of selection bias. Primary hypothesis. Smokers randomized to receive CBT during extended treatment will have a higher prolonged abstinence rate (PA) at 52 week and 104 week follow-up than participants in the Supportive therapy Control treatment.
During open label treatment, all receive CBT and bupropion and nicotine patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and nicotine replacement therapy (NRT) through week 26. Medication will not be available after week 26. All will receive CBT through week 26.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-extended treatment | Active Comparator |
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| Extended treatment | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupropion | Drug | Both groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26. |
| Measure | Description | Time Frame |
|---|---|---|
| Expired-air CO Verified Point-prevalence Abstinence | Self-reported no smoking in last 7 days verified by CO<10 ppm | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Expired-air CO Verified Point-prevalence Abstinence | Self-reported no smoking in last 7 days verified by CO<10 ppm | 104 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean P. David, MD, DPhil | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27357195 | Background | Leyro TM, Crew EE, Bryson SW, Lembke A, Bailey SR, Prochaska JJ, Henriksen L, Fortmann SP, Killen JD, Killen DT, Hall SM, David SP. Retrospective analysis of changing characteristics of treatment-seeking smokers: implications for further reducing smoking prevalence. BMJ Open. 2016 Jun 29;6(6):e010960. doi: 10.1136/bmjopen-2015-010960. | |
| 28239942 | Result | Laude JR, Bailey SR, Crew E, Varady A, Lembke A, McFall D, Jeon A, Killen D, Killen JD, David SP. Extended treatment for cigarette smoking cessation: a randomized control trial. Addiction. 2017 Aug;112(8):1451-1459. doi: 10.1111/add.13806. Epub 2017 May 2. |
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Two participants were withdrawn from the study, of which one withdrew following a medication side effect of tachycardia and one participant was removed from the study for disruptive behavior -- both prior to randomization.
Adult cigarette smokers (N = 223) between the ages of 18 and 65 who smoked at least 10 cigarettes per day were included. Participants were randomized between 06/1/2010 and 01/22/2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Maintenance Therapy | Participants will receive six months (26 weeks) of cognitive behavioral therapy (maintenance treatment) and a monthly phone call after 26 weeks asking about their smoking status and will not receive any treatment. |
| FG001 | Extended Treatment | Participants will receive twelve months (52 weeks) of cognitive behavioral therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Maintenance Treatment | Participants receive 26 weeks of cognitive behavioral therapy (maintenance treatment) followed by a monthly phone call asking about their smoking status and will not receive any additional behavioral treatment after 26 weeks. Cognitive behavior therapy (CBT): During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 26. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Expired-air CO Verified Point-prevalence Abstinence | Self-reported no smoking in last 7 days verified by CO<10 ppm | Posted | Number | participants | 52 weeks |
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Adverse events were monitored over 104 weeks.
Participants were queried at every in-person visit for adverse events and asked to call the health educator if they developed any troubling side effects or medical events. All side effects or adverse events were reported to the study physician who provided clinical advice as needed.
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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 | Maintenance Treatment | Participants receive 26 weeks of cognitive behavioral therapy (maintenance treatment) followed by a monthly phone call asking about their smoking status and will not receive any additional behavioral treatment after 26 weeks. Cognitive behavior therapy (CBT): During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. Maintenance treatment (cognitive behavioral therapy)(CBT): During open label treatment, all receive CBT and bupropion and NRT patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | Systematic Assessment | Rapid heart rate associated with syncopal or near-syncopal event |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Systematic Assessment |
The target sample size of N=400 was not reached due to challenges with recruitment, however, the sample size achieved was sufficient to test main effects of extended treatment on abstinence outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sean P. David | Stanford University | 401-265-2275 | spdavid@stanford.edu |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| D061485 | Tobacco Use Cessation Devices |
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
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Participants were randomized to extended or non-extended treatment and followed for 104 weeks.
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Behavioral therapists were blinded until the end of open-label treatment (26 weeks). Investigators were blinded to treatment assignment until the end of the study.
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| Nicotine patch | Drug | Both groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26. |
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| Varenicline | Drug | Both groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26. |
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| BG001 | Extended Treatment | Participants receive 52 weeks of cognitive behavioral therapy (maintenance plus extended treatment). Cognitive behavior therapy (CBT): During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 52. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Extended Treatment | Participants receive 52 weeks of cognitive behavioral therapy (extended treatment). During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. All will receive CBT through week 52. |
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| Secondary | Expired-air CO Verified Point-prevalence Abstinence | Self-reported no smoking in last 7 days verified by CO<10 ppm | Posted | Number | participants | 104 weeks |
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| 0 |
| 111 |
| 0 |
| 111 |
| 22 |
| 111 |
| EG001 | Extended Treatment | Participants receive 26 weeks of cognitive behavioral therapy (maintenance treatment) followed by another 26 weeks of cognitive behavioral therapy (extended treatment). Cognitive behavior therapy (CBT): During open label treatment, all receive CBT and bupropion and nicotine replacement therapy (NRT) patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications. Those who are abstinent but report difficulty with craving or depression symptoms will remain on zyban and NRT through week 26. Maintenance treatment (cognitive behavioral therapy)(CBT): During open label treatment, all receive CBT and bupropion and NRT patch. At week 10 those who continue to smoke will be switched to varenicline through week 26. At week 10 those who are abstinent and report low levels of cravin | 2 | 112 | 3 | 112 | 20 | 112 |
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| Lung cancer | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Death from lung cancer during the follow-up period |
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| Myocardial infarction | Cardiac disorders | Non-systematic Assessment | Death from myocardial infection during the follow-up period |
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| Dry mouth | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Insomnia | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vivid dreams | Nervous system disorders | Systematic Assessment |
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| D001552 |
| Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |