Clinical trial NCT02995915: Mobile Contingency Management for Concurrent Abstinence From Alcohol and Smoking
Official title: Mobile Contingency Management for Concurrent Abstinence From Alcohol and Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Alcohol Drinking
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Self-report Prolonged Abstinence From Smoking
timeFrame: 6 month follow-up
measure: Number of Participants Whose Prolonged Abstinence From Smoking is Bio-verified
timeFrame: 6 month follow-up
measure: Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use
timeFrame: 6 month follow-up
measure: Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified
timeFrame: 6 month follow-up
measure: Number of Participants Who Self-report Prolonged Dual Abstinence From Both Smoking and Alcohol
timeFrame: 6 month follow-up
measure: Number of Participants Whose Prolonged Dual Abstinence From Alcohol and Smoking is Bio-verified
timeFrame: 6 month follow-up
Secondary outcomes:
measure: Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
timeFrame: 6 month follow-up
measure: Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking
timeFrame: 6 month follow-up
measure: Change in the Proportion of Days in Which Consumed Alcohol Compared to Pre-quit Use
timeFrame: 6 month follow-up
measure: Change in the Number of Standard Alcoholic Beverages Consumed Per Week Compared to Pre-quit Use
timeFrame: 6 month follow-up
measure: Change in the Number of Heavy Drinking Episodes Compared to Pre-quit Use
timeFrame: 6 month follow-up
measure: 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)
timeFrame: 6 month follow-up
measure: Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use
timeFrame: 6 week follow-up (i.e., end of treatment visit)
measure: Number of Participants Whose Prolonged Abstinence From Alcohol is Bio-verified
timeFrame: 6 week follow-up (i.e., end of treatment visit)
measure: Change in Number of Average Cigarettes Smoked Per Day
timeFrame: 6 month follow-up
measure: Change in the Proportion of Days in Which Smoked Compared to Pre-quit Use
timeFrame: 6 month follow-up
measure: Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
timeFrame: 6 week follow-up (i.e., end of treatment visit)
measure: Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
timeFrame: 8 week follow-up (i.e., Session 7, end of monitoring visit)
measure: Number of Participants Who Self-report Prolonged Abstinence From Alcohol Use
timeFrame: 8 week follow-up (i.e., Session 7, end of monitoring visit)
measure: Number of Participants Who Self-report Prolonged Abstinence From Smoking
timeFrame: 6 week follow-up (i.e., end of treatment visit)
measure: Number of Participants Who Self-report Prolonged Abstinence From Smoking
timeFrame: 8 week follow-up (i.e., Session 7, end of monitoring visit)
measure: Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking
timeFrame: 6 week follow-up (i.e., end of treatment visit)
measure: Number of Participants Who Self-report 30 Day Point Prevalence Abstinence From Smoking
timeFrame: 8 week follow-up (i.e., Session 7, end of monitoring visit)
measure: Number of Smoking Quit Attempts
timeFrame: 6 week follow-up (i.e., end of treatment visit)
measure: Number of Smoking Quit Attempts
timeFrame: 8 week follow-up (i.e., Session 7, end of monitoring visit)
measure: Number of Smoking Quit Attempts
timeFrame: 6-month follow-up
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Study Principal Investigator
name: Eric A. Dedert, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: