Mobile Contingency Management for Concurrent Abstinence From Alcohol and Smoking

Smoking Cessation Clinical Trial

Official title:

Mobile Contingency Management for Concurrent Abstinence From Alcohol and Smoking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02995915
• Other study ID #: Pro00062101
• Status: Completed
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: March 2, 2020

Study information

• Verified date: April 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2, 2020
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Alcohol Drinking
• Smoking Cessation

Intervention

Other:
• 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 nicotine lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings

Drug:
• Bupropion
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.

Behavioral:
• 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 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 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Self-report Prolonged Abstinence From Smoking	Participants will be asked to report on smoking since two weeks past quit date	6 month follow-up
Primary	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.	6 month follow-up
Primary	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	6 month follow-up
Primary	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.	6 month follow-up
Primary	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	6 month follow-up
Primary	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.	6 month follow-up
Secondary	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.	6 month follow-up
Secondary	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	6 month follow-up
Secondary	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.	6 month follow-up
Secondary	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.	6 month follow-up
Secondary	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.	6 month follow-up
Secondary	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	6 month follow-up
Secondary	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	6 week follow-up (i.e., end of treatment visit)
Secondary	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.	6 week follow-up (i.e., end of treatment visit)
Secondary	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.	6 month follow-up
Secondary	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.	6 month follow-up
Secondary	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	6 week follow-up (i.e., end of treatment visit)
Secondary	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	8 week follow-up (i.e., Session 7, end of monitoring visit)
Secondary	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	8 week follow-up (i.e., Session 7, end of monitoring visit)
Secondary	Number of Participants Who Self-report Prolonged Abstinence From Smoking	Participants will be asked to report on alcohol use since two weeks past quit	6 week follow-up (i.e., end of treatment visit)
Secondary	Number of Participants Who Self-report Prolonged Abstinence From Smoking	Participants will be asked to report on alcohol use since two weeks past quit	8 week follow-up (i.e., Session 7, end of monitoring visit)
Secondary	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	6 week follow-up (i.e., end of treatment visit)
Secondary	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	8 week follow-up (i.e., Session 7, end of monitoring visit)
Secondary	Number of Smoking Quit Attempts	Participants will be asked to report the number of quit attempts made since quit date	6 week follow-up (i.e., end of treatment visit)
Secondary	Number of Smoking Quit Attempts	Participants will be asked to report the number of quit attempts made since quit date	8 week follow-up (i.e., Session 7, end of monitoring visit)
Secondary	Number of Smoking Quit Attempts	Participants will be asked to report the number of quit attempts made since quit date	6-month follow-up