Smoking CessationPhase 4NCT02995915
Mobile Contingency Management for Concurrent Abstinence From Alcohol and Smoking
A Phase 4 study testing Nicotine Replacement Therapy, Bupropion and Cognitive Behavioral Treatment in people with Smoking Cessation and Alcohol Drinking, run by Duke University at 1 site in United States.
Trial summary
Alcohol misuse and smoking constitute two of the three leading preventable causes of death in the United States. The purpose of this research study is to develop an intervention designed to help people stop drinking alcohol and stop smoking at the same time. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Smoking Cessation, Alcohol Drinking
- What is being tested?
- Nicotine Replacement Therapy, Bupropion and Cognitive Behavioral Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 2 Mar 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- currently meet criteria for DSM-5 mild to moderate alcohol use disorder (meeting 2-5 criteria for AUD)
- have been engaging in hazardous drinking over the past month, defined as either exceeding a mean of 14 standard drinks/wk for men, 7 drinks/wk for women; or by consuming >5 on at least one occasion in the last month for men, >4 drinks on at least one occasion in the last month for women
- currently smoke >10 cigarettes a day, and have smoked for at least one year
- can speak and write fluent conversational English
- are willing to make an attempt to quit both alcohol and smoking
Who cannot join
- are expected to have unstable medication regimen during the study
- are currently receiving non-study behavioral treatment for alcohol use disorder or smoking
- have severe alcohol use disorder (meeting >6 criteria for AUD or having alcohol withdrawal symptom criterion)
- have AUD that is in early remission, with no symptoms evident over the past month
- have experienced myocardial infarction in past 6 months
- contraindication to nicotine replacement therapy with no medical clearance to participate in the study
Show all 11Show fewer
- use other forms of nicotine such as cigars, pipes, or chewing tobacco
- are currently pregnant
- have a primary psychotic disorder or current manic episode
- have had substance use disorder (other than alcohol or nicotine) in the preceding 3 months
- are currently imprisoned or in psychiatric hospitalization
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27706
About this study
Alcohol misuse and smoking constitute two of the three leading preventable causes of death in the United States. The purpose of this research study is to develop an intervention designed to help people stop drinking alcohol and stop smoking at the same time.
Read the detailed description
Alcohol misuse and smoking constitute two of the three leading preventable causes of death in the United States. Reluctance to treat tobacco dependence among those with AUD is misguided as recent research suggests smoking cessation treatment can be effective, does not increase risk of relapse to alcohol, and may even improve rates of sobriety. There is strong evidence for the short-term efficacy for alcohol misuse and smoking of contingency management (CM). It is an intensive behavioral therapy that provides incentives (vouchers, money) to individuals misusing substances contingent upon objective evidence from drug use. Implementation of CM has been limited because of the need to verify abstinence multiple times daily using clinic based monitoring. The investigators recently developed a smart-phone application which allows a patient to video themselves several times daily while using a small CO monitor and to transmit the data to a secure server which has made the use of CM for outpatient smoking cessation portable and feasible. This mobile CM (mCM) approach paired with cognitive-behavioral counseling and pharmacological smoking cessation aids has been effective in reducing smoking.
Thus, the purpose of this project is to develop a combined alcohol and smoking mCM intervention. The intervention will be developed in two successive cohorts of five participants, who will provide information on treatment acceptability and feasibility. A third cohort of participants (n=45) will participate in a randomized clinical trials to further examine feasibility and efficacy. The long term goal is to develop mCM procedures that will be used as part of a multi-component intervention to concurrently and effectively treat both alcohol misuse and smoking. As part of this project, the investigators will develop a multi-component telehealth alcohol and smoking mCM intervention. It will include mCM, cognitive-behavioral phone counseling, and standard smoking cessation pharmacotherapy. The work proposed in these aims will provide the first step toward implementation of an innovative approach that builds upon the power of mHealth technology to reduce the prevalence of both alcohol misuse and smoking.
- Conditions
- Smoking Cessation, Alcohol Drinking
- Being tested
- Nicotine Replacement Therapy, Bupropion, Cognitive Behavioral Treatment, Mobile Contingency Management, Mobile Monitoring
- Medical subject headings
- Smoking Cessation, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement TherapyOther
Also called nicotine gum, patch, inhaler, and/or lozenge
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 nicotine lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
BupropionDrug
Also called Zyban
All participants who are medically eligible 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 TreatmentBehavioural
Also called CBT
Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
Mobile Contingency ManagementBehavioural
Also called mobile CM, mCM
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 asked to upload these videos to the study's secured server, and are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
Mobile MonitoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tele-health Mobile Contingency Management Intervention | Experimental | This arm includes a proactive tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, a tele-medicine clinic for access to smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM). Receives: Other: Nicotine Replacement Therapy; Drug: Bupropion; Behavioral: Cognitive Behavioral Treatment; Behavioral: Mobile Contingency Management |
| Tele-health for Alcohol and Smoking Cessation | Active comparator | This arm includes a proactive 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 tele-medicine clinic for access to smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants will receive monetary compensation for each assessment, regardless of abstinence. Receives: Other: Nicotine Replacement Therapy; Drug: Bupropion; Behavioral: Cognitive Behavioral Treatment; Behavioral: Mobile Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Self-report Prolonged Abstinence From Smoking
Participants will be asked to report on smoking since two weeks past quit date
Measured: 6 month follow-up
Number of Participants Whose Prolonged Abstinence From Smoking is Bio-verified
Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.
Measured: 6 month follow-up
Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use
Participants will be asked to report on alcohol use since two weeks past quit date
Measured: 6 month follow-up
Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified
Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.
Measured: 6 month follow-up
Number of Participants Who Self-report Prolonged Dual Abstinence From Both Smoking and Alcohol
Participants will be asked to report on smoking and alcohol use since two weeks past quit date
Measured: 6 month follow-up
Number of Participants Whose Prolonged Dual Abstinence From Alcohol and Smoking is Bio-verified
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.
Measured: 6 month follow-up
Secondary outcomes (20)
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
Measured: 6 month follow-up
Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking
30-day point prevalence abstinence is defined as no smoking in the prior 30 days
Measured: 6 month follow-up
Change in the Proportion of Days in Which Consumed Alcohol Compared to Pre-quit Use
Participants 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.
Measured: 6 month follow-up
Change in the Number of Standard Alcoholic Beverages Consumed Per Week Compared to Pre-quit Use
Participants 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.
Measured: 6 month follow-up
Change in the Number of Heavy Drinking Episodes Compared to Pre-quit Use
Participants 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.
Measured: 6 month follow-up
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)
Participants will be asked to report on alcohol use in past week
Measured: 6 month follow-up
Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use
Participants will be asked to report on alcohol use since two weeks past quit date
Measured: 6 week follow-up (i.e., end of treatment visit)
Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified
Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.
Measured: 6 week follow-up (i.e., end of treatment visit)
Change in Number of Average Cigarettes Smoked Per Day
Participants 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.
Measured: 6 month follow-up
Change in the Proportion of Days in Which Smoked Compared to Pre-quit Use
Participants 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.
Measured: 6 month follow-up
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
Participants will be asked to report on smoking since two weeks past quit date
Measured: 6 week follow-up (i.e., end of treatment visit)
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
Participants will be asked to report on smoking since two weeks past quit date
Measured: 8 week follow-up (i.e., Session 7, end of monitoring visit)
Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use
Participants will be asked to report on alcohol use since two weeks past quit
Measured: 8 week follow-up (i.e., Session 7, end of monitoring visit)
Number of Participants Who Self-report Prolonged Abstinence From Smoking
Participants will be asked to report on alcohol use since two weeks past quit
Measured: 6 week follow-up (i.e., end of treatment visit)
Number of Participants Who Self-report Prolonged Abstinence From Smoking
Participants will be asked to report on alcohol use since two weeks past quit
Measured: 8 week follow-up (i.e., Session 7, end of monitoring visit)
Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking
Participants will be asked to report on smoking since two weeks past quit date
Measured: 6 week follow-up (i.e., end of treatment visit)
Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking
Participants will be asked to report on smoking since two weeks past quit date
Measured: 8 week follow-up (i.e., Session 7, end of monitoring visit)
Number of Smoking Quit Attempts
Participants will be asked to report the number of quit attempts made since quit date
Measured: 6 week follow-up (i.e., end of treatment visit)
Number of Smoking Quit Attempts
Participants will be asked to report the number of quit attempts made since quit date
Measured: 8 week follow-up (i.e., Session 7, end of monitoring visit)
Number of Smoking Quit Attempts
Participants will be asked to report the number of quit attempts made since quit date
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric A. Dedert, Ph.D., Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995915
- Sponsor's protocol ID
- Pro00062101
- Status last verified
- Apr 2021
- First submitted
- 14 Dec 2016
- Last updated
- 28 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Contingency Management for Concurrent Abstinence From Alcohol and Smoking
- ClinicalTrials.gov ID
- NCT02995915
- Acronym / sponsor ID
- Pro00062101
- Conditions
- Smoking Cessation, Alcohol Drinking
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Posted 28 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alcohol misuse and smoking constitute two of the three leading preventable causes of death in the United States. The purpose of this research study is to develop an intervention designed to help people stop drinking alcohol and stop smoking at the same time.
Detailed description
Alcohol misuse and smoking constitute two of the three leading preventable causes of death in the United States. Reluctance to treat tobacco dependence among those with AUD is misguided as recent research suggests smoking cessation treatment can be effective, does not increase risk of relapse to alcohol, and may even improve rates of sobriety. There is strong evidence for the short-term efficacy for alcohol misuse and smoking of contingency management (CM). It is an intensive behavioral therapy that provides incentives (vouchers, money) to individuals misusing substances contingent upon objective evidence from drug use. Implementation of CM has been limited because of the need to verify abstinence multiple times daily using clinic based monitoring. The investigators recently developed a smart-phone application which allows a patient to video themselves several times daily while using a small CO monitor and to transmit the data to a secure server which has made the use of CM for outpatient smoking cessation portable and feasible. This mobile CM (mCM) approach paired with cognitive-behavioral counseling and pharmacological smoking cessation aids has been effective in reducing smoking.
Thus, the purpose of this project is to develop a combined alcohol and smoking mCM intervention. The intervention will be developed in two successive cohorts of five participants, who will provide information on treatment acceptability and feasibility. A third cohort of participants (n=45) will participate in a randomized clinical trials to further examine feasibility and efficacy. The long term goal is to develop mCM procedures that will be used as part of a multi-component intervention to concurrently and effectively treat both alcohol misuse and smoking. As part of this project, the investigators will develop a multi-component telehealth alcohol and smoking mCM intervention. It will include mCM, cognitive-behavioral phone counseling, and standard smoking cessation pharmacotherapy. The work proposed in these aims will provide the first step toward implementation of an innovative approach that builds upon the power of mHealth technology to reduce the prevalence of both alcohol misuse and smoking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-health Mobile Contingency Management Intervention | Experimental | Other: Nicotine Replacement Therapy, Drug: Bupropion, Behavioral: Cognitive Behavioral Treatment, Behavioral: Mobile Contingency ManagementThis arm includes a proactive tele-health intervention that combines evidence-based telephone cognitive behavioral treatment for alcohol and smoking cessation, a tele-medicine clinic for access to smoking cessation pharmacotherapy (including nicotine replacement therapy and bupropion), and mobile contingency management treatment administered via a smart-phone based application (mobile CM). |
| Tele-health for Alcohol and Smoking Cessation | Active comparator | Other: Nicotine Replacement Therapy, Drug: Bupropion, Behavioral: Cognitive Behavioral Treatment, Behavioral: Mobile MonitoringThis arm includes a proactive 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 tele-medicine clinic for access to smoking cessation pharmacotherapy as in the mCM intervention, but does not include mCM. Instead, participants will receive monetary compensation for each assessment, regardless of abstinence. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- currently meet criteria for DSM-5 mild to moderate alcohol use disorder (meeting 2-5 criteria for AUD)
- have been engaging in hazardous drinking over the past month, defined as either exceeding a mean of 14 standard drinks/wk for men, 7 drinks/wk for women; or by consuming >5 on at least one occasion in the last month for men, >4 drinks on at least one occasion in the last month for women
- currently smoke >10 cigarettes a day, and have smoked for at least one year
- can speak and write fluent conversational English
- are willing to make an attempt to quit both alcohol and smoking
Key exclusion criteria (11 listed)
- are expected to have unstable medication regimen during the study
- are currently receiving non-study behavioral treatment for alcohol use disorder or smoking
- have severe alcohol use disorder (meeting >6 criteria for AUD or having alcohol withdrawal symptom criterion)
- have AUD that is in early remission, with no symptoms evident over the past month
- have experienced myocardial infarction in past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Replacement TherapyAlso: nicotine gum, patch, inhaler, and/or lozengeParticipants 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 nicotine lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings | Other | Tele-health Mobile Contingency Management Intervention, Tele-health for Alcohol and Smoking Cessation |
| BupropionAlso: ZybanAll participants who are medically eligible 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. | Drug | Tele-health Mobile Contingency Management Intervention, Tele-health for Alcohol and Smoking Cessation |
| Cognitive Behavioral TreatmentAlso: CBTParticipants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation. | Behavioural | Tele-health Mobile Contingency Management Intervention, Tele-health for Alcohol and Smoking Cessation |
| Mobile Contingency ManagementAlso: mobile CM, mCMParticipants 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 asked to upload these videos to the study's secured server, and are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence. | Behavioural | Tele-health Mobile Contingency Management Intervention |
| Mobile MonitoringParticipants 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. | Behavioural | Tele-health for Alcohol and Smoking Cessation |
Primary outcome
Number of Participants Who Self-report Prolonged Abstinence From Smoking
Time frame: 6 month follow-up
Participants will be asked to report on smoking since two weeks past quit date
Number of Participants Whose Prolonged Abstinence From Smoking is Bio-verified
Time frame: 6 month follow-up
Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.
Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use
Time frame: 6 month follow-up
Participants will be asked to report on alcohol use since two weeks past quit date
Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified
Time frame: 6 month follow-up
Self-reported prolonged abstinence will be verified by breathalyzer. Breathalyzer data will be collected from participants who self-report prolonged abstinence.
Number of Participants Who Self-report Prolonged Dual Abstinence From Both Smoking and Alcohol
Time frame: 6 month follow-up
Participants will be asked to report on smoking and alcohol use since two weeks past quit date
Number of Participants Whose Prolonged Dual Abstinence From Alcohol and Smoking is Bio-verified
Time frame: 6 month follow-up
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.
20 secondary outcomes
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
Time frame: 6 month follow-up
Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking
Time frame: 6 month follow-up
Change in the Proportion of Days in Which Consumed Alcohol Compared to Pre-quit Use
Time frame: 6 month follow-up
Change in the Number of Standard Alcoholic Beverages Consumed Per Week Compared to Pre-quit Use
Time frame: 6 month follow-up
Change in the Number of Heavy Drinking Episodes Compared to Pre-quit Use
Time frame: 6 month follow-up
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)
Time frame: 6 month follow-up
Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use
Time frame: 6 week follow-up (i.e., end of treatment visit)
Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified
Time frame: 6 week follow-up (i.e., end of treatment visit)
Change in Number of Average Cigarettes Smoked Per Day
Time frame: 6 month follow-up
Change in the Proportion of Days in Which Smoked Compared to Pre-quit Use
Time frame: 6 month follow-up
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
Time frame: 6 week follow-up (i.e., end of treatment visit)
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
Time frame: 8 week follow-up (i.e., Session 7, end of monitoring visit)
Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use
Time frame: 8 week follow-up (i.e., Session 7, end of monitoring visit)
Number of Participants Who Self-report Prolonged Abstinence From Smoking
Time frame: 6 week follow-up (i.e., end of treatment visit)
Number of Participants Who Self-report Prolonged Abstinence From Smoking
Time frame: 8 week follow-up (i.e., Session 7, end of monitoring visit)
Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking
Time frame: 6 week follow-up (i.e., end of treatment visit)
Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking
Time frame: 8 week follow-up (i.e., Session 7, end of monitoring visit)
Number of Smoking Quit Attempts
Time frame: 6 week follow-up (i.e., end of treatment visit)
Number of Smoking Quit Attempts
Time frame: 8 week follow-up (i.e., Session 7, end of monitoring visit)
Number of Smoking Quit Attempts
Time frame: 6-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric A. Dedert, Ph.D. principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine Replacement Therapy, Bupropion and Cognitive Behavioral Treatment in people with Smoking Cessation and Alcohol Drinking, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Self-report Prolonged Abstinence From Smoking (time frame: 6 month follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.