Mobile Contingency Management for Marijuana and Tobacco Cessation

Cigarette Smoking Clinical Trial

Official title:

Mobile Contingency Management for Concurrent Abstinence From Cannabis and Cigarette Smoking: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869451
• Other study ID #: Pro00072366
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: May 17, 2017

Study information

• Verified date: January 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 17, 2017
• Est. primary completion date: May 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• report 40 or more days of cannabis use in the past 90 day;

• have smoked at least seven cigarettes in the past seven days;

• have been smoking for at least the past year;

• can speak and write fluent conversational English;

• are between 18 and 70 years of age; and

• are willing to make an attempt to quit both cannabis and tobacco smoking.

Exclusion Criteria:

• expected to have unstable medication regimen during the study;

• currently receiving non-study behavioral treatment for cannabis use disorder or smoking;

• myocardial infarction in past six months;

• contraindication to NRT with no medical clearance;

• use of other forms of nicotine such as cigars, pipes, or chewing tobacco with unwillingness to stop use of these forms;

• current pregnancy;

• primary psychotic disorder or current manic episode;

• substance use disorder (other than cannabis or nicotine) within the preceding three months; or

• current imprisonment or psychiatric hospitalization.

Related Conditions & MeSH terms

• Cigarette Smoking
• Marijuana Abuse

Intervention

Drug:
• bupropion
Prescribed one week prior to quit and continued until the 6 month follow-up visit.
• transdermal nicotine patch
Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant
• Nicotine polacrilex
Initiated at smoking quit date.
• nicotine lozenge
Initiated at smoking quit date.

Behavioral:
• counseling for marijuana and smoking cessation
5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention
• mobile contingency management
treatment that provides money rewards for abstinence from smoking and marijuana

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 month follow up
Primary	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.	6 month follow up
Primary	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.	6 month follow up
Primary	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.	6 month follow up
Secondary	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.	6 month follow up
Secondary	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.	6 month follow up
Secondary	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.	6 month follow up
Secondary	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.	6 month follow up
Secondary	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.	3 month follow up
Secondary	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.	3 month follow up
Secondary	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.	3 month follow up
Secondary	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.	3 month follow up
Secondary	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.	baseline, 6 month follow up
Secondary	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.	30 days prior to quit date, 6 month follow up
Secondary	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	7 days prior to quit date, 6 month follow up
Secondary	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.	30 days prior to quit date, 6 month follow up
Secondary	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	3 month follow up
Secondary	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	3 month follow up
Secondary	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	Evaluated at 6 month follow-up