Trial Outcomes & Findings for Extended Treatment for Smoking Cessation (NCT NCT01330043)

NCT ID: NCT01330043

Last Updated: 2017-08-01

Results Overview

Self-reported no smoking in last 7 days verified by CO\<10 ppm

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 223 participants
• Primary outcome timeframe: 52 weeks
• Results posted on: 2017-08-01

Participant Flow

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.

Two participants were withdrawn from the study, of which one withdrew following a medication side effect of tachycardia and one participant was removed from the study for disruptive behavior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.

Participant milestones

Measure	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.	Extended Treatment Participants will receive twelve months (52 weeks) of cognitive behavioral therapy.
Overall Study STARTED	111	112
Overall Study COMPLETED	111	108
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Extended Treatment for Smoking Cessation

Baseline characteristics by cohort

Measure	Maintenance Treatment n=111 Participants 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 At week 10 those who are abstinent and report low levels of craving and low levels of depression symptoms will be withdrawn from study medications.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.	Extended Treatment n=112 Participants 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.	Total n=223 Participants Total of all reporting groups
Age, Continuous	42 years STANDARD_DEVIATION 12 • n=5 Participants	43 years STANDARD_DEVIATION 12 • n=7 Participants	43 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	46 Participants n=7 Participants	89 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	66 Participants n=7 Participants	134 Participants n=5 Participants
Region of Enrollment United States	111 participants n=5 Participants	112 participants n=7 Participants	223 participants n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

Self-reported no smoking in last 7 days verified by CO<10 ppm

Outcome measures

Measure	Maintenance Treatment n=111 Participants 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. 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.	Extended Treatment n=108 Participants 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.
Expired-air CO Verified Point-prevalence Abstinence	44 participants	42 participants

SECONDARY outcome

Timeframe: 104 weeks

Self-reported no smoking in last 7 days verified by CO<10 ppm

Outcome measures

Measure	Maintenance Treatment n=111 Participants 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. 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.	Extended Treatment n=108 Participants 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.
Expired-air CO Verified Point-prevalence Abstinence	39 participants	33 participants

Adverse Events

Maintenance Treatment

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Extended Treatment

Serious events: 3 serious events

Other events: 20 other events

Deaths: 2 deaths

Serious adverse events

Measure	Maintenance Treatment n=111 participants at risk 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	Extended Treatment n=112 participants at risk 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
Cardiac disorders Tachycardia	0.00% 0/111 • 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.	0.89% 1/112 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Lung cancer	0.00% 0/111 • 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.	0.89% 1/112 • Number of events 1 • 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.
Cardiac disorders Myocardial infarction	0.00% 0/111 • 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.	0.89% 1/112 • Number of events 1 • 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.

Other adverse events

Measure	Maintenance Treatment n=111 participants at risk 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	Extended Treatment n=112 participants at risk 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
Psychiatric disorders Anxiety	9.9% 11/111 • Number of events 11 • 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.	7.1% 8/112 • Number of events 8 • 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.
General disorders Dry mouth	13.5% 15/111 • Number of events 15 • 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.	9.8% 11/112 • Number of events 11 • 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.
Nervous system disorders Headache	5.4% 6/111 • Number of events 6 • 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.	8.0% 9/112 • Number of events 9 • 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.
Nervous system disorders Insomnia	14.4% 16/111 • Number of events 16 • 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.	11.6% 13/112 • Number of events 13 • 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.
Gastrointestinal disorders Nausea	8.1% 9/111 • Number of events 9 • 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.	3.6% 4/112 • Number of events 4 • 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.
Nervous system disorders Vivid dreams	19.8% 22/111 • Number of events 22 • 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.	17.9% 20/112 • Number of events 20 • 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.

Additional Information

Dr. Sean P. David

Stanford University

Phone: 401-265-2275

Email: spdavid@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place