Mobile Contingency Management for Marijuana and Tobacco Cessation

January 28, 2020 updated by: Duke University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27706
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
Cognitive-behavioral counseling for marijuana and smoking cessation, mobile contingency management for marijuana and smoking cessation, transdermal nicotine patch (7-21 mg over six weeks), nicotine polacrilex or nicotine lozenge (4 mg administered as needed over six weeks), bupropion (150 mg once per day for 7 days, then 150 mg twice per day for about six months.
Drug: bupropion
Prescribed one week prior to quit and continued until the 6 month follow-up visit.
Other Names:
  • Zyban
Drug: transdermal nicotine patch
Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant
Drug: Nicotine polacrilex
Initiated at smoking quit date.
Other Names:
  • nicotine gum; nicorette
Drug: 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
Behavioral: mobile contingency management
treatment that provides money rewards for abstinence from smoking and marijuana

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Self-report Prolonged Abstinence From Smoking
Time Frame: 6 month follow up
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
Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine
Time Frame: 6 month follow up
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
Number of Participants Who Self-report Prolonged Abstinence From Marijuana Use
Time Frame: 6 month follow up
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
Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Oral Fluid
Time Frame: 6 month follow up
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
Time Frame: 6 month follow up
7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
6 month follow up
Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking
Time Frame: 6 month follow up
30-day point prevalence abstinence is defined as no smoking in the prior 30 days.
6 month follow up
Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking
Time Frame: 3 month follow up
7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
3 month follow up
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Marijuana
Time Frame: 6 month follow up
7-day point prevalence abstinence is defined as no marijuana use in the prior 7 days.
6 month follow up
Number of Participants Who Report 30 Day Point Prevalence Abstinence From Marijuana
Time Frame: 6 month follow up
30-day point prevalence abstinence is defined as no marijuana use in the prior 30 days.
6 month follow up
Number of Participants Who Report 7 Day Point Prevalence Abstinence From Marijuana
Time Frame: 3 month follow up
7-day point prevalence abstinence is defined as no marijuana use in the prior 7 days.
3 month follow up
Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine
Time Frame: 3 month follow up
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
Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Salivary Cotinine
Time Frame: 3 month follow up
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
Change From Baseline in Number of Days Per Week of Cannabis Use
Time Frame: baseline, 6 month follow up
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
Proportional Change in Days of Cannabis Use From Pre-quit to 6 Month Follow-up (Entire Group)
Time Frame: 30 days prior to quit date, 6 month follow up
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
Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit
Time Frame: 7 days prior to quit date, 6 month follow up
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
Proportional Change in Days Smoked From Pre-quit to 6-month Follow up (for Entire Group)
Time Frame: 30 days prior to quit date, 6 month follow up
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
Percentage of Missing Mobile Contingency Management Video Recordings
Time Frame: 3 month follow up
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
Number of Missed Behavioral Counseling Sessions
Time Frame: 3 month follow up
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
Number of Voluntary Withdrawals From the Project
Time Frame: Evaluated at 6 month follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean C Beckham, Ph.D., Study Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 17, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 17, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00072366

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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