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Mobile Contingency Management for Marijuana and Tobacco Cessation

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ClinicalTrials.gov Identifier: NCT02869451
Recruitment Status : Completed
First Posted : August 17, 2016
Results First Posted : April 9, 2018
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Cigarette Smoking Marijuana Abuse Drug: bupropion Drug: transdermal nicotine patch Drug: Nicotine polacrilex Drug: nicotine lozenge Behavioral: counseling for marijuana and smoking cessation Behavioral: mobile contingency management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mobile Contingency Management for Concurrent Abstinence From Cannabis and Cigarette Smoking: A Pilot Study
Actual Study Start Date : August 2016
Actual Primary Completion Date : May 17, 2017
Actual Study Completion Date : May 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana Smoking

Arm Intervention/treatment
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 Name: 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 Name: 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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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.

  13. 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

  14. 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

  15. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02869451


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27706
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Jean C Beckham, Ph.D. Study Principal Investigator
  Study Documents (Full-Text)

Documents provided by Duke University:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02869451    
Other Study ID Numbers: Pro00072366
First Posted: August 17, 2016    Key Record Dates
Results First Posted: April 9, 2018
Last Update Posted: February 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Bupropion
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors