Cigarette Smoking, Marijuana Abuse
Conditions
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.
Interventions
DRUGbupropion
Prescribed one week prior to quit and continued until the 6 month follow-up visit.
DRUGtransdermal nicotine patch
Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant
Initiated at smoking quit date.
DRUGnicotine lozenge
Initiated at smoking quit date.
BEHAVIORALcounseling for marijuana and smoking cessation
5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention
BEHAVIORALmobile contingency management
treatment that provides money rewards for abstinence from smoking and marijuana
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Oral Fluid | 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. |
| Number of Participants Who Self-report Prolonged Abstinence From Smoking | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking | 3 month follow up | 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 | 3 month follow up | 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 | 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. |
| Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Salivary Cotinine | 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. |
| Change From Baseline in Number of Days Per Week of Cannabis Use | 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. |
| Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking | 6 month follow up | 7-day point prevalence abstinence is defined as no smoking in the prior 7 days. |
| Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit | 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 |
| Proportional Change in Days Smoked From Pre-quit to 6-month Follow up (for Entire Group) | 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. |
| Percentage of Missing Mobile Contingency Management Video Recordings | 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 |
| Number of Missed Behavioral Counseling Sessions | 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 |
| Number of Voluntary Withdrawals From the Project | 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 |
| Proportional Change in Days of Cannabis Use From Pre-quit to 6 Month Follow-up (Entire Group) | 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. |
| Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Marijuana | 6 month follow up | 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 | 6 month follow up | 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 | 6 month follow up | 30-day point prevalence abstinence is defined as no smoking in the prior 30 days. |
Countries
United States
Participant flow
Recruitment details
Study recruitment occurred between August 2016 to May 2017. Participants were recruited from community settings and Craigslist.
Pre-assignment details
Seven participants signed consent. Two of these participants were withdrawn by the principal investigator after signing consent because they did not meet study eligibility criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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.
bupropion: Prescribed one week prior to quit and continued until the 6 month follow-up visit.
transdermal nicotine patch: Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant
Nicotine polacrilex: Initiated at smoking quit date.
nicotine lozenge: Initiated at smoking quit date.
counseling for marijuana and smoking cessation: 5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention
mobile contingency management: treatment that provides money rewards for abstinence from smoking and marijuana | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 43.6 years STANDARD_DEVIATION 8.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 1 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
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.
Time frame: 6 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Oral Fluid | 0 Participants |
Primary
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.
Time frame: 6 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine | 0 Participants |
Primary
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.
Time frame: 6 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Who Self-report Prolonged Abstinence From Marijuana Use | 0 Participants |
Primary
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.
Time frame: 6 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Who Self-report Prolonged Abstinence From Smoking | 0 Participants |
Secondary
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.
Time frame: baseline, 6 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Change From Baseline in Number of Days Per Week of Cannabis Use | -3.4 days per week of marijuana use | Standard Deviation 1.34 |
Secondary
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
Time frame: 7 days prior to quit date, 6 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit | -37.8 number of cigarettes per wk | Standard Deviation 39.16 |
Secondary
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
Time frame: 3 month follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Number of Missed Behavioral Counseling Sessions | 0 missed counseling sessions |
Secondary
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.
Time frame: 6 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Who Report 30 Day Point Prevalence Abstinence From Marijuana | 1 Participants |
Secondary
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.
Time frame: 6 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking | 1 Participants |
Secondary
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.
Time frame: 3 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Who Report 7 Day Point Prevalence Abstinence From Marijuana | 3 Participants |
Secondary
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.
Time frame: 3 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking | 0 Participants |
Secondary
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.
Time frame: 3 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Salivary Cotinine | 3 Participants |
Secondary
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.
Time frame: 3 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine | 0 Participants |
Secondary
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.
Time frame: 6 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Marijuana | 2 Participants |
Secondary
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.
Time frame: 6 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking | 1 Participants |
Secondary
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
Time frame: Evaluated at 6 month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Voluntary Withdrawals From the Project | 0 Participants |
Secondary
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
Time frame: 3 month follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Percentage of Missing Mobile Contingency Management Video Recordings | 33.9 percent missed video recordings |
Secondary
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.
Time frame: 30 days prior to quit date, 6 month follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Proportional Change in Days of Cannabis Use From Pre-quit to 6 Month Follow-up (Entire Group) | 28 percentage of pre-quit use |
Secondary
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.
Time frame: 30 days prior to quit date, 6 month follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Proportional Change in Days Smoked From Pre-quit to 6-month Follow up (for Entire Group) | 80 percentage of pre-quit use |