Mobile Contingency Management for Concurrent Abstinence From Alcohol and Smoking

NCT02995915 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00062101
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Alcohol Drinking

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (20)

• Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking

  6 month follow-up

• Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking

  6 month follow-up

• Change in the Proportion of Days in Which Consumed Alcohol Compared to Pre-quit Use

  6 month follow-up

• Change in the Number of Standard Alcoholic Beverages Consumed Per Week Compared to Pre-quit Use

  6 month follow-up

• Change in the Number of Heavy Drinking Episodes Compared to Pre-quit Use

  6 month follow-up

Study Arms (2)

Tele-health Mobile Contingency Management Intervention

EXPERIMENTAL

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).

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

Tele-health for Alcohol and Smoking Cessation

ACTIVE COMPARATOR

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.

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

Interventions

Nicotine Replacement Therapy 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

Also known as: nicotine gum, patch, inhaler, and/or lozenge

Tele-health Mobile Contingency Management Intervention; Tele-health for Alcohol and Smoking Cessation

Bupropion 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.

Also known as: Zyban

Tele-health Mobile Contingency Management Intervention; Tele-health for Alcohol and Smoking Cessation

Cognitive Behavioral Treatment BEHAVIORAL

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

Also known as: CBT

Tele-health Mobile Contingency Management Intervention; Tele-health for Alcohol and Smoking Cessation

Mobile Contingency Management 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.

Also known as: mobile CM, mCM

Tele-health Mobile Contingency Management Intervention

Mobile Monitoring 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.

Tele-health for Alcohol and Smoking Cessation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27706, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Alcohol Drinking

Interventions

Nicotine Replacement Therapy; Nicotine Chewing Gum; Transdermal Patch; Nebulizers and Vaporizers; Bupropion

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Drinking Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Equipment and Supplies; Propiophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Angela Kirby, MS
• Organization: Duke University Medical Center

angela.kirby@duke.edu

(919) 824-7729

Study Officials

• Eric A. Dedert, Ph.D.

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 19, 2016
• Study Start: November 1, 2016
• Primary Completion: March 2, 2020
• Study Completion: March 2, 2020
• Last Updated: April 28, 2021
• Results First Posted: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)