Mobile Contingency Management for Concurrent Abstinence From Alcohol and Smoking

Duke University

Status and phase: Completed; Phase 4

Conditions: Smoking Cessation; Alcohol Drinking

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02995915

Pro00062101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Tele-health Mobile Contingency Management Intervention

Experimental group

Description:

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).

Treatment:

Behavioral: Mobile Contingency Management

Other: Nicotine Replacement Therapy

Drug: Bupropion

Behavioral: Cognitive Behavioral Treatment

Tele-health for Alcohol and Smoking Cessation

Active Comparator group

Description:

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.

Treatment:

Other: Nicotine Replacement Therapy

Behavioral: Mobile Monitoring

Drug: Bupropion

Behavioral: Cognitive Behavioral Treatment