Mobile Contingency Management for Concurrent Abstinence From Alcohol and Smoking

Phase 4

Completed

Conditions: Smoking Cessation
Alcohol Drinking

Interventions: Other: Nicotine Replacement Therapy
Drug: Bupropion
Behavioral: Cognitive Behavioral Treatment
Behavioral: Mobile Contingency Management
Behavioral: Mobile Monitoring

Registration Number: NCT02995915

Lead Sponsor: Duke University

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 45

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tele-health for Alcohol and Smoking Cessation	Nicotine Replacement Therapy	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.
Tele-health for Alcohol and Smoking Cessation	Cognitive Behavioral Treatment	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.
Tele-health Mobile Contingency Management Intervention	Nicotine Replacement Therapy	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).
Tele-health Mobile Contingency Management Intervention	Mobile Contingency Management	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).
Tele-health Mobile Contingency Management Intervention	Cognitive Behavioral Treatment	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).
Tele-health for Alcohol and Smoking Cessation	Mobile Monitoring	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.
Tele-health Mobile Contingency Management Intervention	Bupropion	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).
Tele-health for Alcohol and Smoking Cessation	Bupropion	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Self-report Prolonged Dual Abstinence From Both Smoking and Alcohol	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 Abstinence From Smoking is Bio-verified	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 Whose Prolonged Abstinence From Alcohol is Bio-verified	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 Abstinence From Smoking	6 month follow-up	Participants will be asked to report on smoking since two weeks past quit date
Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use	6 month follow-up	Participants will be asked to report on alcohol use since two weeks past quit date
Number of Participants Whose Prolonged Dual Abstinence From Alcohol and Smoking is Bio-verified	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking	6 month follow-up	30-day point prevalence abstinence is defined as no smoking in the prior 30 days
Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use	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
Number of Smoking Quit Attempts	6-month follow-up	Participants will be asked to report the number of quit attempts made since quit date
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking	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
Change in the Proportion of Days in Which Consumed Alcohol Compared to Pre-quit Use	6 month follow-up	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.
Change in the Number of Standard Alcoholic Beverages Consumed Per Week Compared to Pre-quit Use	6 month follow-up	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.
Change in the Number of Heavy Drinking Episodes Compared to Pre-quit Use	6 month follow-up	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.
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)	6 month follow-up	Participants will be asked to report on alcohol use in past week
Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified	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.
Change in Number of Average Cigarettes Smoked Per Day	6 month follow-up	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.
Number of Participants Who Self-report Prolonged Abstinence From Smoking	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
Change in the Proportion of Days in Which Smoked Compared to Pre-quit Use	6 month follow-up	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.
Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking	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