Tobacco Use Disorder
Conditions
Keywords
Smoking Cessation
Brief summary
The purpose of this study is to better understand tobacco outcomes using a well-known stop smoking medication, varenicline, and financial incentives with tobacco users. The investigators are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive tobacco cessation treatment (varenicline) for 12 weeks. This study will recruit adult tobacco users (ages 18-40) who are motivated to quit smoking cigarettes.
Detailed description
Cannabis co-use among tobacco users is exceedingly common and rates of co-use appear to be increasing among adults in the US, which is consistent with overall increases in cannabis use rates among US adults. Given the current cannabis landscape, further increases in cannabis use are likely and may result in continued increases in the co-use of cannabis and tobacco. Despite high rates of co-use, there is little consensus regarding treatment recommendations for this population and an understanding of the impact of co-use on successful cessation. The literature on the impact of co-use on tobacco cessation outcomes specifically has been mixed and fraught with limitations, including methodological variation, lack of biochemical verification to confirm cannabis use status and severity, and variations in study samples. Currently, no prospective studies have been conducted to evaluate the impact of cannabis use on tobacco cessation outcomes. Further, no studies have collected cannabis use changes during tobacco cessation treatment to assess for concurrent reductions, abstinence, or of greater concern, compensatory (i.e., increased) use as a result of tobacco reduction/abstinence. This study is a prospective 12-week tobacco cessation trial using established methods and outcomes typical of tobacco cessation trials, but specifically recruiting co-users of cannabis. The aims of this proposed study are to; 1) examine the impact of cannabis co-use on tobacco cessation outcomes among co-users compared to tobacco only participants (Aim #1), 2) among cannabis co-users, assess changes in cannabis use during tobacco treatment (Aim #2), and 3) assess for a dose-dependent impact of cannabis co-use severity on tobacco cessation (Exploratory Aim #1).
Interventions
DRUGVarenicline
Varenicline is a medication approved by the Food and Drug Administration for the treatment of tobacco use disorder among adults (ages 18 and over). In this study, all participants will be administered active medication for the recommended 12 week treatment period. The standard dose titration schedule will be used, which includes 0.5 mg once per day (q.d.) on Days 1-3, 0.5 mg twice per day (b.i.d.) on Days 4-7, and 1.0 mg b.i.d. starting on Day 8. Dosing of 2.0 mg per day will be maintained for the next 11 weeks, for a total of 12 weeks of active treatment for all study participants.
BEHAVIORALContingency Management
Contingency management procedures will be implemented and financial incentives will be provided at weekly visits contingent on tobacco abstinence verified through urinary qualitative cotinine (starting at Week 2). A set amount of $20 per study visit will be delivered based on a negative qualitative urinary cotinine result.
BEHAVIORALCounseling
Psychosocial counseling will be administered by trained research staff leading up to the target quit date and throughout the study. Counseling will include motivational enhancement for medication adherence and tobacco cessation. The content of counseling will be skills-based and will focus on enlisting social support, recognizing smoking triggers, managing craving/withdrawal/stress, etc.
Sponsors
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Medical University of South Carolina
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Between the ages of 18 and 40 years old 2. Must be able to understand the study and provide written informed consent 3. Daily cigarette smoker for ≥ 6 months, smoking ≥ 5 cigarettes per day 4. Must submit a breath carbon monoxide (CO) sample of ≥ 7 parts per million (ppm) at the screening visit 5. Be interested in quitting smoking tobacco cigarettes (defined as a 5 or above on a 10-point Likert scale assessing interest in quitting \[1=not at all interested, 10=extremely interested\]) 6. Must be willing to take varenicline for the standard 12-week course of treatment 7. If female, agreement to use birth control (any form) to avoid pregnancy during study procedures Additional inclusion criteria will be implemented for cannabis co-users, which include: 8. Self-reported use of cannabis on at least 10 out of the past 30 days or submit a positive qualitative urinary cannabinoid test at screening (limit of detection is 50 ng/ml)
Exclusion criteria
1. Any serious or unstable medical/psychiatric disorder (including severe substance use disorders, other than cannabis or tobacco use disorders) or other significant concern in the past three months that may interfere with study performance, impact participant safety, compliance with study procedures, or potentially confound the interpretation of findings 2. Currently pregnant, lactating, or contemplating pregnancy in the next 6 months 3. Current use of medications with smoking cessation efficacy 4. Use of any medications that would interfere with varenicline 5. No regular use of other tobacco or nicotine products other than combustible cigarettes (e.g., smokeless tobacco, electronic cigarettes, etc.) in the past month prior to the quit attempt
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Biologically Verified 7-day Point Prevalence Tobacco Abstinence at the End of Treatment (Week 12) | Final 7 days of treatment (Week 12) | 7-day point prevalence abstinence from tobacco at the end of treatment (Week 12) will be assessed via biochemical verification (urinary cotinine; ng/ml) and will be compared between cannabis co-users and tobacco only controls. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cannabis Use During Tobacco Cessation Treatment (Among Co-users) | Final 4 weeks of study treatment (Weeks 9-12) | Among cannabis co-users (n=110), cannabis use (based on urinary cannabinoids \[ng/ml\]) during the final 4 weeks of tobacco treatment (Weeks 9-12) will be assessed. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the community at three sites across South Carolina, USA; MUSC Charleston (Charleston, SC), Behavioral Health Services of Pickens County (BHS, Pickens, SC) and MUSC Florence (Florence, SC). Enrollment ran from January 2020 until March 2024, with the MUSC Florence site being added in 2022. A total of 259 participants were screened for eligibility and 181 (70%) were enrolled
Participants by arm
| Arm | Count |
|---|---|
| Co-Use Group Cannabis and tobacco co-use group.
Varenicline: Varenicline is a medication approved by the Food and Drug Administration for the treatment of tobacco use disorder among adults (ages 18 and over). In this study, all participants will be administered active medication for the recommended 12 week treatment period. The standard dose titration schedule will be used, which includes 0.5 mg once per day (q.d.) on Days 1-3, 0.5 mg twice per day (b.i.d.) on Days 4-7, and 1.0 mg b.i.d. starting on Day 8. Dosing of 2.0 mg per day will be maintained for the next 11 weeks, for a total of 12 weeks of active treatment for all study participants.
Contingency Management: Contingency management procedures will be implemented and financial incentives will be provided at weekly visits contingent on tobacco abstinence verified through urinary qualitative cotinine (starting at Week 2). A set amount of $20 per study visit will be delivered based on a negative qualitative urinary cotinine result.
Counseling: Psychosocial counseling will be administered by trained research staff leading up to the target quit date and throughout the study. Counseling will include motivational enhancement for medication adherence and tobacco cessation. The content of counseling will be skills-based and will focus on enlisting social support, recognizing smoking triggers, managing craving/withdrawal/stress, etc. | 110 |
| Tobacco Only Group Tobacco only group.
Varenicline: Varenicline is a medication approved by the Food and Drug Administration for the treatment of tobacco use disorder among adults (ages 18 and over). In this study, all participants will be administered active medication for the recommended 12 week treatment period. The standard dose titration schedule will be used, which includes 0.5 mg once per day (q.d.) on Days 1-3, 0.5 mg twice per day (b.i.d.) on Days 4-7, and 1.0 mg b.i.d. starting on Day 8. Dosing of 2.0 mg per day will be maintained for the next 11 weeks, for a total of 12 weeks of active treatment for all study participants.
Contingency Management: Contingency management procedures will be implemented and financial incentives will be provided at weekly visits contingent on tobacco abstinence verified through urinary qualitative cotinine (starting at Week 2). A set amount of $20 per study visit will be delivered based on a negative qualitative urinary cotinine result.
Counseling: Psychosocial counseling will be administered by trained research staff leading up to the target quit date and throughout the study. Counseling will include motivational enhancement for medication adherence and tobacco cessation. The content of counseling will be skills-based and will focus on enlisting social support, recognizing smoking triggers, managing craving/withdrawal/stress, etc. | 71 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 26 | 11 |
| Overall Study | Withdrawal by Subject | 18 | 5 |
Baseline characteristics
| Characteristic | Co-Use Group | Total | Tobacco Only Group |
|---|---|---|---|
| Age, Continuous | 32.3 years STANDARD_DEVIATION 5.6 | 33.1 years STANDARD_DEVIATION 5.5 | 34.5 years STANDARD_DEVIATION 5.1 |
| Cigarettes per day (assessed in the 30 days prior to screening/baseline)) | 13.4 cigarettes per day STANDARD_DEVIATION 7.8 | 14.1 cigarettes per day STANDARD_DEVIATION 7.6 | 14.9 cigarettes per day STANDARD_DEVIATION 7.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 11 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 102 Participants | 170 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 34 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 73 Participants | 135 Participants | 62 Participants |
| Region of Enrollment United States | 110 participants | 181 participants | 71 participants |
| Sex: Female, Male Female | 47 Participants | 89 Participants | 42 Participants |
| Sex: Female, Male Male | 63 Participants | 92 Participants | 29 Participants |
| Sex/Gender, Customized Gender Identity Man | 62 Participants | 89 Participants | 27 Participants |
| Sex/Gender, Customized Gender Identity Other/Unknown | 1 Participants | 3 Participants | 2 Participants |
| Sex/Gender, Customized Gender Identity Woman | 47 Participants | 89 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 71 |
| other Total, other adverse events | 76 / 110 | 56 / 71 |
| serious Total, serious adverse events | 1 / 110 | 1 / 71 |
Outcome results
Primary
Number of Participants With Biologically Verified 7-day Point Prevalence Tobacco Abstinence at the End of Treatment (Week 12)
7-day point prevalence abstinence from tobacco at the end of treatment (Week 12) will be assessed via biochemical verification (urinary cotinine; ng/ml) and will be compared between cannabis co-users and tobacco only controls.
Time frame: Final 7 days of treatment (Week 12)
Population: Estimation of the primary outcome was completed using 3 methods: 1) simple imputation (missing=smoking), 2) methods of multiple imputation, and 3) utilizing all available data (number analyzed is lower in each compared to imputation methods).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Co-Use Group | Number of Participants With Biologically Verified 7-day Point Prevalence Tobacco Abstinence at the End of Treatment (Week 12) | Number of Participants with 7-day Point Prevalence Abstinence: Simple Imputation | 30 Participants |
| Co-Use Group | Number of Participants With Biologically Verified 7-day Point Prevalence Tobacco Abstinence at the End of Treatment (Week 12) | Number of Participants with 7-day Point Prevalence Abstinence: Multiple Imputation | 36 Participants |
| Co-Use Group | Number of Participants With Biologically Verified 7-day Point Prevalence Tobacco Abstinence at the End of Treatment (Week 12) | Number of Participants with 7-day Point Prevalence Abstinence: Available Data | 30 Participants |
| Tobacco Only Group | Number of Participants With Biologically Verified 7-day Point Prevalence Tobacco Abstinence at the End of Treatment (Week 12) | Number of Participants with 7-day Point Prevalence Abstinence: Simple Imputation | 40 Participants |
| Tobacco Only Group | Number of Participants With Biologically Verified 7-day Point Prevalence Tobacco Abstinence at the End of Treatment (Week 12) | Number of Participants with 7-day Point Prevalence Abstinence: Multiple Imputation | 42 Participants |
| Tobacco Only Group | Number of Participants With Biologically Verified 7-day Point Prevalence Tobacco Abstinence at the End of Treatment (Week 12) | Number of Participants with 7-day Point Prevalence Abstinence: Available Data | 40 Participants |
Secondary
Cannabis Use During Tobacco Cessation Treatment (Among Co-users)
Among cannabis co-users (n=110), cannabis use (based on urinary cannabinoids \[ng/ml\]) during the final 4 weeks of tobacco treatment (Weeks 9-12) will be assessed.
Time frame: Final 4 weeks of study treatment (Weeks 9-12)
Population: All participants in the cannabis co-use group (n=110) with any data available during the final 4 weeks of study treatment (weeks 9-12). A total of 75 participants had data available for at least one of the final 4 weekly visits. The tobacco-only group was not included in this outcome.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Co-Use Group | Cannabis Use During Tobacco Cessation Treatment (Among Co-users) | Week 9 urinary cannabinoids [ng/ml] | 405 urinary cannabinoids in ng/ml | Standard Error 96 |
| Co-Use Group | Cannabis Use During Tobacco Cessation Treatment (Among Co-users) | Week 10 urinary cannabinoids [ng/ml] | 402 urinary cannabinoids in ng/ml | Standard Error 98 |
| Co-Use Group | Cannabis Use During Tobacco Cessation Treatment (Among Co-users) | Week 11 urinary cannabinoids [ng/ml] | 376 urinary cannabinoids in ng/ml | Standard Error 86 |
| Co-Use Group | Cannabis Use During Tobacco Cessation Treatment (Among Co-users) | Week 12 urinary cannabinoids [ng/ml] | 414 urinary cannabinoids in ng/ml | Standard Error 88 |