Clinical trial NCT02869451: Mobile Contingency Management for Marijuana and Tobacco Cessation
Official title: Mobile Contingency Management for Concurrent Abstinence From Cannabis and Cigarette Smoking: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Marijuana Abuse
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Self-report Prolonged Abstinence From Smoking
timeFrame: 6 month follow up
measure: Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine
timeFrame: 6 month follow up
measure: Number of Participants Who Self-report Prolonged Abstinence From Marijuana Use
timeFrame: 6 month follow up
measure: Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Oral Fluid
timeFrame: 6 month follow up
Secondary outcomes:
measure: Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
timeFrame: 6 month follow up
measure: Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Marijuana
timeFrame: 6 month follow up
measure: Number of Participants Who Report 30 Day Point Prevalence Abstinence From Marijuana
timeFrame: 6 month follow up
measure: Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking
timeFrame: 6 month follow up
measure: Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking
timeFrame: 3 month follow up
measure: Number of Participants Who Report 7 Day Point Prevalence Abstinence From Marijuana
timeFrame: 3 month follow up
measure: Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine
timeFrame: 3 month follow up
measure: Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Salivary Cotinine
timeFrame: 3 month follow up
measure: Change From Baseline in Number of Days Per Week of Cannabis Use
timeFrame: baseline, 6 month follow up
measure: Proportional Change in Days of Cannabis Use From Pre-quit to 6 Month Follow-up (Entire Group)
timeFrame: 30 days prior to quit date, 6 month follow up
measure: Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit
timeFrame: 7 days prior to quit date, 6 month follow up
measure: Proportional Change in Days Smoked From Pre-quit to 6-month Follow up (for Entire Group)
timeFrame: 30 days prior to quit date, 6 month follow up
measure: Percentage of Missing Mobile Contingency Management Video Recordings
timeFrame: 3 month follow up
measure: Number of Missed Behavioral Counseling Sessions
timeFrame: 3 month follow up
measure: Number of Voluntary Withdrawals From the Project
timeFrame: Evaluated at 6 month follow-up
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Study Principal Investigator
name: Jean C Beckham, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: