The purpose of this pilot project is to pilot-test a combined cannabis and smoking cessation treatment. The intervention combines mobile technology with behavioral strategies, counseling, and medications.
Cannabis is the most widely used illicit drug in the United States with 19.8 million current users. Population based data indicate that almost all cannabis users (90%) have a lifetime history of tobacco smoking and the majority (74%) currently smoke tobacco. While cannabis use alone is associated with significant adverse health effects, tobacco smoking is the number one preventable cause of illness and death in the U.S. This is true even among those using illicit drugs where the tobacco -related mortality rate is twice that of the general population. Among cannabis users, smoking tobacco is associated with increased frequency of marijuana use, increased morbidity, and poorer cannabis cessation outcomes. There is strong evidence for the short -term efficacy for cannabis use disorder (CUD) 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 and effects are short lived. 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. The mobile CM (mCM) approach paired with cognitive-behavioral counseling and pharmacological smoking cessation aids has been effective in reducing smoking in the short and long-term. The purpose of this pilot project is to pilot-test a combined cannabis and smoking mCM intervention. The pilot will allow the investigators to examine feasibility of the treatment and of planned recruitment strategies. These project 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 CUD and cigarette smoking.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Prescribed one week prior to quit and continued until the 6 month follow-up visit.
Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant
Initiated at smoking quit date.
Duke University Medical Center
Durham, North Carolina, United States
Number of Participants Who Self-report Prolonged Abstinence From Smoking
Participants self-report smoking behavior since smoking quit date. Prolonged abstinence is defined as sustained abstinence since two weeks post-initial smoking quit date.
Time frame: 6 month follow up
Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine
Self-reported abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.
Time frame: 6 month follow up
Number of Participants Who Self-report Prolonged Abstinence From Marijuana Use
Participants self-report marijuana use since marijuana quit date. Prolonged abstinence is defined as sustained abstinence since two weeks post-initial quit date.
Time frame: 6 month follow up
Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Oral Fluid
Self-reported abstinence (primary outcome) will be verified by oral fluid (OF) cannabis assessment. Oral fluid samples will be collected from participants who self-report prolonged abstinence.
Time frame: 6 month follow up
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.
Time frame: 6 month follow up
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Marijuana
7-day point prevalence abstinence is defined as no marijuana use in the prior 7 days.
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Initiated at smoking quit date.
5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention
treatment that provides money rewards for abstinence from smoking and marijuana
Time frame: 6 month follow up
Number of Participants Who Report 30 Day Point Prevalence Abstinence From Marijuana
30-day point prevalence abstinence is defined as no marijuana use in the prior 30 days.
Time frame: 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.
Time frame: 6 month follow up
Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking
7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
Time frame: 3 month follow up
Number of Participants Who Report 7 Day Point Prevalence Abstinence From Marijuana
7-day point prevalence abstinence is defined as no marijuana use in the prior 7 days.
Time frame: 3 month follow up
Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine
Self-reported abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.
Time frame: 3 month follow up
Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Salivary Cotinine
Self-reported abstinence (primary outcome) will be verified by oral fluid (OF) cannabis assessment. Oral fluid samples will be collected from participants who self-report prolonged abstinence.
Time frame: 3 month follow up
Change From Baseline in Number of Days Per Week of Cannabis Use
Participants will self-report amount of marijuana used in past week; this will be compared to self-reported amount smoked per week prior to quit date.
Time frame: baseline, 6 month follow up
Proportional Change in Days of Cannabis Use From Pre-quit to 6 Month Follow-up (Entire Group)
Participants will self-report number of days marijuana used in the past 30 days and this will be compared for the entire group to self-reported number of days of use in 30 days prior to quit. The proportion will be calculated by totaling baseline days used and pretreatment days used, and then dividing baseline days used by pretreatment days used.
Time frame: 30 days prior to quit date, 6 month follow up
Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit
Self-reported number of cigarettes smoked each day in past 7 days; this will be compared to self-reported amount smoked in week prior to quit date
Time frame: 7 days prior to quit date, 6 month follow up
Proportional Change in Days Smoked From Pre-quit to 6-month Follow up (for Entire Group)
Participants will self-report number of days smoked in the past 30 days and this will be compared (for the entire group) to self-reported number of days smoked in 30 days prior to quit. The proportion will be calculated by totaling baseline days used and pretreatment days used, and then dividing baseline days used by pretreatment days used.
Time frame: 30 days prior to quit date, 6 month follow up
Percentage of Missing Mobile Contingency Management Video Recordings
Participants upload video recordings of abstinence verification as part of contingency management treatment. Percentage of missed videos (compared to expected videos) will be assessed as a measure of feasibility of the contingency management intervention
Time frame: 3 month follow up
Number of Missed Behavioral Counseling Sessions
Participants attend telephone counseling sessions. Number of missed sessions for the total group will be assessed as a measure of acceptability of the behavioral counseling
Time frame: 3 month follow up
Number of Voluntary Withdrawals From the Project
The number of participants who withdraw from the study will be evaluated as a measure of treatment feasibility and acceptability
Time frame: Evaluated at 6 month follow-up