Trial Outcomes & Findings for Mobile Contingency Management for Concurrent Abstinence From Alcohol and Smoking (NCT NCT02995915)
NCT ID: NCT02995915
Last Updated: 2021-04-28
Results Overview
Participants will be asked to report on smoking since two weeks past quit date
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
45 participants
Primary outcome timeframe
6 month follow-up
Results posted on
2021-04-28
Participant Flow
Participant milestones
| Measure |
Tele-health Mobile Contingency Management Intervention
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
15
|
|
Overall Study
COMPLETED
|
30
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobile Contingency Management for Concurrent Abstinence From Alcohol and Smoking
Baseline characteristics by cohort
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.77 years
STANDARD_DEVIATION 11.39 • n=5 Participants
|
42.67 years
STANDARD_DEVIATION 11.46 • n=7 Participants
|
42.73 years
STANDARD_DEVIATION 11.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 month follow-upParticipants will be asked to report on smoking since two weeks past quit date
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Who Self-report Prolonged Abstinence From Smoking
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 month follow-upSelf-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Whose Prolonged Abstinence From Smoking is Bio-verified
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 month follow-upParticipants will be asked to report on alcohol use since two weeks past quit date
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 month follow-upPopulation: This subset of participants self-reported prolonged abstinence from alcohol.
Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=4 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 month follow-upParticipants will be asked to report on smoking and alcohol use since two weeks past quit date
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Who Self-report Prolonged Dual Abstinence From Both Smoking and Alcohol
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 month follow-upPopulation: This subset of participants self-reported dual abstinence from alcohol use and smoking.
Self-reported prolonged abstinence from smoking will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=1 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Whose Prolonged Dual Abstinence From Alcohol and Smoking is Bio-verified
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 month follow-up7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 month follow-up30-day point prevalence abstinence is defined as no smoking in the prior 30 days
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 month follow-upParticipants will self-report number of days drank alcohol in the past 30 days and this will be compared to self-reported number of days drank alcohol in 30 days prior to quit.
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Change in the Proportion of Days in Which Consumed Alcohol Compared to Pre-quit Use
|
-9.67 drinking days per month
Standard Deviation 9.68
|
-10.3 drinking days per month
Standard Deviation 10.69
|
SECONDARY outcome
Timeframe: 6 month follow-upParticipants will self-report number of alcoholic beverages consumed in past 7 days and this will be compared to self-reported number of alcoholic beverages consumed in 7 days prior to quit.
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Change in the Number of Standard Alcoholic Beverages Consumed Per Week Compared to Pre-quit Use
|
-7.53 drinks per week
Standard Deviation 17.54
|
-13.9 drinks per week
Standard Deviation 17.72
|
SECONDARY outcome
Timeframe: 6 month follow-upParticipants will self-report number of heavy drinking episodes in the past 30 days and this will be compared to self-reported number of heavy drinking episodes in 30 days prior to quit.
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Change in the Number of Heavy Drinking Episodes Compared to Pre-quit Use
|
-9.22 heavy drinking episodes
Standard Deviation 10.22
|
-11.00 heavy drinking episodes
Standard Deviation 9.61
|
SECONDARY outcome
Timeframe: 6 month follow-upParticipants will be asked to report on alcohol use in past week
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Who Are Able to Achieve Recommended Drinking Limits (i.e., Less Than or Equal to 14 Drinks Per Week and Fewer Than 5 Drinks Per Day for Men; Less Than or Equal to 7 Days Per Week and Less Than 4 Drinks Per Day for Women)
|
16 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 week follow-up (i.e., end of treatment visit)Participants will be asked to report on alcohol use since two weeks past quit date
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use
|
14 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 week follow-up (i.e., end of treatment visit)Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified
|
13 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 month follow-upParticipants will self-report average number of cigarettes smoked in the past week and this will be compared to self-reported number of smoked in the week prior to quit.
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Change in Number of Average Cigarettes Smoked Per Day
|
-8.56 cigarettes per day
Standard Deviation 7.45
|
-5.30 cigarettes per day
Standard Deviation 6.50
|
SECONDARY outcome
Timeframe: 6 month follow-upParticipants will self-report number of days smoked in the past 30 days and this will be compared to self-reported number of days smoked 30 days prior to quit.
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Change in the Proportion of Days in Which Smoked Compared to Pre-quit Use
|
-9.22 days
Standard Deviation 10.98
|
-4.70 days
Standard Deviation 11.50
|
SECONDARY outcome
Timeframe: 6 week follow-up (i.e., end of treatment visit)Participants will be asked to report on smoking since two weeks past quit date
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
|
12 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 8 week follow-up (i.e., Session 7, end of monitoring visit)Participants will be asked to report on smoking since two weeks past quit date
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
|
13 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 8 week follow-up (i.e., Session 7, end of monitoring visit)Participants will be asked to report on alcohol use since two weeks past quit
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use
|
13 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 week follow-up (i.e., end of treatment visit)Participants will be asked to report on alcohol use since two weeks past quit
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Who Self-report Prolonged Abstinence From Smoking
|
11 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 week follow-up (i.e., Session 7, end of monitoring visit)Participants will be asked to report on alcohol use since two weeks past quit
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Who Self-report Prolonged Abstinence From Smoking
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 week follow-up (i.e., end of treatment visit)Participants will be asked to report on smoking since two weeks past quit date
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 8 week follow-up (i.e., Session 7, end of monitoring visit)Participants will be asked to report on smoking since two weeks past quit date
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 week follow-up (i.e., end of treatment visit)Participants will be asked to report the number of quit attempts made since quit date
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Smoking Quit Attempts
|
2.25 smoking quit attempts
Standard Deviation 6.58
|
0.86 smoking quit attempts
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: 8 week follow-up (i.e., Session 7, end of monitoring visit)Participants will be asked to report the number of quit attempts made since quit date
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Smoking Quit Attempts
|
0.44 smoking quit attempts
Standard Deviation 1.03
|
4.11 smoking quit attempts
Standard Deviation 9.84
|
SECONDARY outcome
Timeframe: 6-month follow-upParticipants will be asked to report the number of quit attempts made since quit date
Outcome measures
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 Participants
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 Participants
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Number of Smoking Quit Attempts
|
2.29 smoking quit attempts
Standard Deviation 7.17
|
1.00 smoking quit attempts
Standard Deviation 1.64
|
Adverse Events
Tele-health Mobile Contingency Management Intervention
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Tele-health for Alcohol and Smoking Cessation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 participants at risk
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 participants at risk
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Gastrointestinal disorders
Hospitalization secondary to burned esophagus
|
3.3%
1/30 • Number of events 1 • Adverse events were collected for approximately seven months, from informed consent signature to the 6-month follow-up visit, which occurred six months after the substance quit date (session 4).
|
0.00%
0/15 • Adverse events were collected for approximately seven months, from informed consent signature to the 6-month follow-up visit, which occurred six months after the substance quit date (session 4).
|
|
General disorders
Hospitalization secondary to flu
|
3.3%
1/30 • Number of events 1 • Adverse events were collected for approximately seven months, from informed consent signature to the 6-month follow-up visit, which occurred six months after the substance quit date (session 4).
|
0.00%
0/15 • Adverse events were collected for approximately seven months, from informed consent signature to the 6-month follow-up visit, which occurred six months after the substance quit date (session 4).
|
Other adverse events
| Measure |
Tele-health Mobile Contingency Management Intervention
n=30 participants at risk
This arm includes a tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM).
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: All medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency Management: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
|
Tele-health for Alcohol and Smoking Cessation
n=15 participants at risk
This arm includes a tele-health intervention that will provide controls for therapist, medication, time and attention effects. The tele-health intervention provides the same evidence-based telephone CBT for alcohol and smoking cessation, and smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants receive monetary compensation for each assessment, regardless of abstinence.
Nicotine Replacement Therapy: Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
Bupropion: medically eligible participants will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
Cognitive Behavioral Treatment: Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Monitoring: Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea/diarrhea
|
6.7%
2/30 • Number of events 3 • Adverse events were collected for approximately seven months, from informed consent signature to the 6-month follow-up visit, which occurred six months after the substance quit date (session 4).
|
0.00%
0/15 • Adverse events were collected for approximately seven months, from informed consent signature to the 6-month follow-up visit, which occurred six months after the substance quit date (session 4).
|
|
Psychiatric disorders
Increased stress
|
3.3%
1/30 • Number of events 2 • Adverse events were collected for approximately seven months, from informed consent signature to the 6-month follow-up visit, which occurred six months after the substance quit date (session 4).
|
0.00%
0/15 • Adverse events were collected for approximately seven months, from informed consent signature to the 6-month follow-up visit, which occurred six months after the substance quit date (session 4).
|
|
Psychiatric disorders
Threat of domestic violence
|
3.3%
1/30 • Number of events 1 • Adverse events were collected for approximately seven months, from informed consent signature to the 6-month follow-up visit, which occurred six months after the substance quit date (session 4).
|
0.00%
0/15 • Adverse events were collected for approximately seven months, from informed consent signature to the 6-month follow-up visit, which occurred six months after the substance quit date (session 4).
|
|
Surgical and medical procedures
Dental surgery
|
3.3%
1/30 • Number of events 1 • Adverse events were collected for approximately seven months, from informed consent signature to the 6-month follow-up visit, which occurred six months after the substance quit date (session 4).
|
0.00%
0/15 • Adverse events were collected for approximately seven months, from informed consent signature to the 6-month follow-up visit, which occurred six months after the substance quit date (session 4).
|
|
Psychiatric disorders
Increase in depressed mood
|
3.3%
1/30 • Number of events 1 • Adverse events were collected for approximately seven months, from informed consent signature to the 6-month follow-up visit, which occurred six months after the substance quit date (session 4).
|
0.00%
0/15 • Adverse events were collected for approximately seven months, from informed consent signature to the 6-month follow-up visit, which occurred six months after the substance quit date (session 4).
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
3.3%
1/30 • Number of events 1 • Adverse events were collected for approximately seven months, from informed consent signature to the 6-month follow-up visit, which occurred six months after the substance quit date (session 4).
|
0.00%
0/15 • Adverse events were collected for approximately seven months, from informed consent signature to the 6-month follow-up visit, which occurred six months after the substance quit date (session 4).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place