Cigarette SmokingNCT02869451
Mobile Contingency Management for Marijuana and Tobacco Cessation
A study testing bupropion, transdermal nicotine patch and Nicotine polacrilex in people with Cigarette Smoking and Marijuana Abuse, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cigarette Smoking, Marijuana Abuse
- What is being tested?
- bupropion, transdermal nicotine patch and Nicotine polacrilex
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 17 May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27706
About this study
Official title: 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.
Read the 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.
- Conditions
- Cigarette Smoking, Marijuana Abuse
- Being tested
- bupropion, transdermal nicotine patch, Nicotine polacrilex, nicotine lozenge, counseling for marijuana and smoking cessation
- Medical subject headings
- Cigarette Smoking, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupropionDrug
Also called Zyban
Prescribed one week prior to quit and continued until the 6 month follow-up visit.
transdermal nicotine patchDrug
Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant
Nicotine polacrilexDrug
Also called nicotine gum; nicorette
Initiated at smoking quit date.
nicotine lozengeDrug
Initiated at smoking quit date.
counseling for marijuana and smoking cessationBehavioural
5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention
mobile contingency managementBehavioural
treatment that provides money rewards for abstinence from smoking and marijuana
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Drug: bupropion; Drug: transdermal nicotine patch; Drug: Nicotine polacrilex; Drug: nicotine lozenge; Behavioral: counseling for marijuana and smoking cessation; Behavioral: mobile contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month follow up
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.
Measured: 6 month follow up
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.
Measured: 6 month follow up
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.
Measured: 6 month follow up
Secondary outcomes (15)
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.
Measured: 6 month follow up
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.
Measured: 6 month follow up
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.
Measured: 6 month follow up
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.
Measured: 6 month follow up
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.
Measured: 3 month follow up
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.
Measured: 3 month follow up
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.
Measured: 3 month follow up
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.
Measured: 3 month follow up
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.
Measured: baseline, 6 month follow up
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.
Measured: 30 days prior to quit date, 6 month follow up
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
Measured: 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)
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.
Measured: 30 days prior to quit date, 6 month follow up
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
Measured: 3 month follow up
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
Measured: 3 month follow up
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
Measured: Evaluated at 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion17 May 2017
- Study completion17 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean C Beckham, Ph.D., Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869451
- Sponsor's protocol ID
- Pro00072366
- Status last verified
- Jan 2020
- First submitted
- 8 Aug 2016
- Last updated
- 7 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Contingency Management for Concurrent Abstinence From Cannabis and Cigarette Smoking: A Pilot Study
- ClinicalTrials.gov ID
- NCT02869451
- Acronym / sponsor ID
- Pro00072366
- Conditions
- Cigarette Smoking, Marijuana Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 17 May 2017 (actual)
- Study completion
- 17 May 2017 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Posted 9 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: bupropion, Drug: transdermal nicotine patch, Drug: Nicotine polacrilex, Drug: nicotine lozenge, Behavioral: counseling for marijuana and smoking cessation, Behavioral: mobile contingency managementCognitive-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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupropionAlso: ZybanPrescribed one week prior to quit and continued until the 6 month follow-up visit. | Drug | Treatment |
| transdermal nicotine patchInitiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant | Drug | Treatment |
| Nicotine polacrilexAlso: nicotine gum; nicoretteInitiated at smoking quit date. | Drug | Treatment |
| nicotine lozengeInitiated at smoking quit date. | Drug | Treatment |
| counseling for marijuana and smoking cessation5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention | Behavioural | Treatment |
| mobile contingency managementtreatment that provides money rewards for abstinence from smoking and marijuana | Behavioural | Treatment |
Primary outcome
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.
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.
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.
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.
15 secondary outcomes
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking
Time frame: 6 month follow up
Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Marijuana
Time frame: 6 month follow up
Number of Participants Who Report 30 Day Point Prevalence Abstinence From Marijuana
Time frame: 6 month follow up
Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking
Time frame: 6 month follow up
Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking
Time frame: 3 month follow up
Number of Participants Who Report 7 Day Point Prevalence Abstinence From Marijuana
Time frame: 3 month follow up
Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine
Time frame: 3 month follow up
Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Salivary Cotinine
Time frame: 3 month follow up
Change From Baseline in Number of Days Per Week of Cannabis Use
Time frame: 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
Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit
Time frame: 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
Percentage of Missing Mobile Contingency Management Video Recordings
Time frame: 3 month follow up
Number of Missed Behavioral Counseling Sessions
Time frame: 3 month follow up
Number of Voluntary Withdrawals From the Project
Time frame: Evaluated at 6 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean C Beckham, Ph.D. principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bupropion, transdermal nicotine patch and Nicotine polacrilex in people with Cigarette Smoking and Marijuana Abuse, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Self-report Prolonged Abstinence From Smoking (time frame: 6 month follow up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.