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Mobile Contingency Management for Marijuana and Tobacco Cessation

Primary Purpose

Cigarette Smoking, Marijuana Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
bupropion
transdermal nicotine patch
Nicotine polacrilex
nicotine lozenge
counseling for marijuana and smoking cessation
mobile contingency management
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cigarette Smoking

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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
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
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

Full Information

First Posted
August 8, 2016
Last Updated
January 28, 2020
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02869451
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
May 17, 2017 (Actual)
Study Completion Date
May 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cigarette Smoking, Marijuana Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
bupropion
Other Intervention Name(s)
Zyban
Intervention Description
Prescribed one week prior to quit and continued until the 6 month follow-up visit.
Intervention Type
Drug
Intervention Name(s)
transdermal nicotine patch
Intervention Description
Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant
Intervention Type
Drug
Intervention Name(s)
Nicotine polacrilex
Other Intervention Name(s)
nicotine gum; nicorette
Intervention Description
Initiated at smoking quit date.
Intervention Type
Drug
Intervention Name(s)
nicotine lozenge
Intervention Description
Initiated at smoking quit date.
Intervention Type
Behavioral
Intervention Name(s)
counseling for marijuana and smoking cessation
Intervention Description
5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention
Intervention Type
Behavioral
Intervention Name(s)
mobile contingency management
Intervention Description
treatment that provides money rewards for abstinence from smoking and marijuana
Primary Outcome Measure Information:
Title
Number of Participants Who Self-report Prolonged Abstinence From Smoking
Description
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
Title
Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine
Description
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
Title
Number of Participants Who Self-report Prolonged Abstinence From Marijuana Use
Description
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
Title
Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Oral Fluid
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
Description
7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
Time Frame
6 month follow up
Title
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Marijuana
Description
7-day point prevalence abstinence is defined as no marijuana use in the prior 7 days.
Time Frame
6 month follow up
Title
Number of Participants Who Report 30 Day Point Prevalence Abstinence From Marijuana
Description
30-day point prevalence abstinence is defined as no marijuana use in the prior 30 days.
Time Frame
6 month follow up
Title
Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking
Description
30-day point prevalence abstinence is defined as no smoking in the prior 30 days.
Time Frame
6 month follow up
Title
Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking
Description
7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
Time Frame
3 month follow up
Title
Number of Participants Who Report 7 Day Point Prevalence Abstinence From Marijuana
Description
7-day point prevalence abstinence is defined as no marijuana use in the prior 7 days.
Time Frame
3 month follow up
Title
Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine
Description
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
Title
Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Salivary Cotinine
Description
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
Title
Change From Baseline in Number of Days Per Week of Cannabis Use
Description
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
Title
Proportional Change in Days of Cannabis Use From Pre-quit to 6 Month Follow-up (Entire Group)
Description
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
Title
Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit
Description
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
Title
Proportional Change in Days Smoked From Pre-quit to 6-month Follow up (for Entire Group)
Description
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
Title
Percentage of Missing Mobile Contingency Management Video Recordings
Description
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
Title
Number of Missed Behavioral Counseling Sessions
Description
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
Title
Number of Voluntary Withdrawals From the Project
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean C Beckham, Ph.D.
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27706
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Mobile Contingency Management for Marijuana and Tobacco Cessation

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