Smoking Cessation
Conditions
Keywords
smoking cessation intervention
Brief summary
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.
Detailed description
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 At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications.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.
Interventions
DRUGBupropion
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 At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications.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.
DRUGNicotine patch
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 At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications.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.
DRUGVarenicline
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.
Sponsors
National Institute on Drug Abuse (NIDA)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
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.
Intervention model description
Participants were randomized to extended or non-extended treatment and followed for 104 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age at least 18 years at the beginning of the study Smoking at least 10 cigarettes a day (1/2 pack)
Exclusion criteria
1. Currently pregnant 2. Currently breastfeeding 3. Currently diagnosed with a seizure disorder, major depression, liver disease, kidney disease, congestive heart failure or diabetes mellitus 4. History of a seizure, seizure disorder, significant head trauma or central nervous system tumor 5. Family history of seizures 6. Currently using intravenous drugs 7. Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis 8. Currently using any over-the-counter stimulants and anorectics (diet pills) 9. Currently on bupropion (Wellbutrin, Wellbutrin SR) or other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa 10. Currently on NRT or bupropion (Zyban) 11. Current or past diagnosis of anorexia nervosa or bulimia nervosa 12. Previous allergic response to bupropion or NRT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expired-air CO Verified Point-prevalence Abstinence | 52 weeks | Self-reported no smoking in last 7 days verified by CO\<10 ppm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expired-air CO Verified Point-prevalence Abstinence | 104 weeks | Self-reported no smoking in last 7 days verified by CO\<10 ppm |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 111 |
| 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. | 112 |
| Total | 223 |
Baseline characteristics
| Characteristic | Maintenance Treatment | Extended Treatment | Total |
|---|---|---|---|
| Age, Continuous | 42 years STANDARD_DEVIATION 12 | 43 years STANDARD_DEVIATION 12 | 43 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 111 participants | 112 participants | 223 participants |
| Sex: Female, Male Female | 43 Participants | 46 Participants | 89 Participants |
| Sex: Female, Male Male | 68 Participants | 66 Participants | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 111 | 2 / 112 |
| other Total, other adverse events | 22 / 111 | 20 / 112 |
| serious Total, serious adverse events | 0 / 111 | 3 / 112 |
Outcome results
Primary
Expired-air CO Verified Point-prevalence Abstinence
Self-reported no smoking in last 7 days verified by CO\<10 ppm
Time frame: 52 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maintenance Treatment | Expired-air CO Verified Point-prevalence Abstinence | 44 participants |
| Extended Treatment | Expired-air CO Verified Point-prevalence Abstinence | 42 participants |
Secondary
Expired-air CO Verified Point-prevalence Abstinence
Self-reported no smoking in last 7 days verified by CO\<10 ppm
Time frame: 104 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maintenance Treatment | Expired-air CO Verified Point-prevalence Abstinence | 39 participants |
| Extended Treatment | Expired-air CO Verified Point-prevalence Abstinence | 33 participants |