Mobile Contingency Management for Concurrent Abstinence From Alcohol and Smoking

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking; Smoking Cessation
• Intervention / Treatment: Drug: Bupropion; Other: Nicotine Replacement Therapy; Behavioral: Cognitive Behavioral Treatment; Behavioral: Mobile Contingency Management; Behavioral: Mobile Monitoring

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27706
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tele-health Mobile Contingency Management Intervention; 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).	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.; Other Names: Zyban; 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; Other Names: nicotine gum, patch, inhaler, and/or lozenge; Behavioral: Cognitive Behavioral Treatment; Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.; Other Names: CBT; Behavioral: 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.; Other Names: mobile CM, mCM
Active Comparator: Tele-health for Alcohol and Smoking Cessation; 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.	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.; Other Names: Zyban; 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; Other Names: nicotine gum, patch, inhaler, and/or lozenge; Behavioral: Cognitive Behavioral Treatment; Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.; Other Names: CBT; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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)
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)
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
Number of Smoking Quit Attempts	Participants will be asked to report the number of quit attempts made since quit date	6-month follow-up

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Eric A. Dedert, Ph.D., Study Principal Investigator

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): March 2, 2020
• Study Completion (Actual): March 2, 2020

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimate): December 19, 2016

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 1, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Nicotine; Bupropion
• Other Study ID Numbers: Pro00062101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No