Mobile Contingency Management for Concurrent Abstinence From Alcohol and Smoking

NCT ID: NCT02995915

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2020-03-02

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.

Conditions

Smoking Cessation; Alcohol Drinking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Nicotine Replacement Therapy

Intervention Type: OTHER

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

Bupropion

Intervention Type: DRUG

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.

Cognitive Behavioral Treatment

Intervention Type: BEHAVIORAL

Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.

Mobile Contingency Management

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Nicotine Replacement Therapy

Intervention Type: OTHER

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

Bupropion

Intervention Type: DRUG

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.

Cognitive Behavioral Treatment

Intervention Type: BEHAVIORAL

Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.

Mobile Monitoring

Intervention Type: BEHAVIORAL

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.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: DRUG

Cognitive Behavioral Treatment

Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

nicotine gum, patch, inhaler, and/or lozenge; Zyban; CBT; mobile CM, mCM

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric A. Dedert, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00062101

Identifier Type: -

Identifier Source: org_study_id