Trial Outcomes & Findings for Cannabis and Tobacco Co-use Study (NCT NCT04228965)
NCT ID: NCT04228965
Last Updated: 2025-06-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
181 participants
Primary outcome timeframe
Final 7 days of treatment (Week 12)
Results posted on
2025-06-15
Participant Flow
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
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
71
|
|
Overall Study
COMPLETED
|
66
|
55
|
|
Overall Study
NOT COMPLETED
|
44
|
16
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
26
|
11
|
|
Overall Study
Withdrawal by Subject
|
18
|
5
|
Baseline Characteristics
Cannabis and Tobacco Co-use Study
Baseline characteristics by cohort
| Measure |
Co-Use Group
n=110 Participants
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.
|
Tobacco Only Group
n=71 Participants
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.
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.3 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
34.5 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
33.1 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex/Gender, Customized
Gender Identity · Woman
|
47 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identity · Man
|
62 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender Identity · Other/Unknown
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
102 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
110 participants
n=5 Participants
|
71 participants
n=7 Participants
|
181 participants
n=5 Participants
|
|
Cigarettes per day (assessed in the 30 days prior to screening/baseline))
|
13.4 cigarettes per day
STANDARD_DEVIATION 7.8 • n=5 Participants
|
14.9 cigarettes per day
STANDARD_DEVIATION 7.2 • n=7 Participants
|
14.1 cigarettes per day
STANDARD_DEVIATION 7.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Co-Use Group
n=110 Participants
Cannabis and tobacco co-use group, defined as use of cannabis on 10+ out of the past 30 days or submitted a positive qualitative urinary cannabinoid test at screening.
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: 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.
|
Tobacco Only Group
n=71 Participants
Tobacco only group, defined as ≥ 5 cigarettes per day and not using cannabis 10 or more days in the past 30 nor submitting a positive qualitative urinary cannabinoid test at screening.
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: 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.
|
|---|---|---|
|
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
|
40 Participants
|
|
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
|
42 Participants
|
|
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
|
40 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Co-Use Group
n=75 Participants
Cannabis and tobacco co-use group, defined as use of cannabis on 10+ out of the past 30 days or submitted a positive qualitative urinary cannabinoid test at screening.
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: 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.
|
Tobacco Only Group
Tobacco only group, defined as ≥ 5 cigarettes per day and not using cannabis 10 or more days in the past 30 nor submitting a positive qualitative urinary cannabinoid test at screening.
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: 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.
|
|---|---|---|
|
Cannabis Use During Tobacco Cessation Treatment (Among Co-users)
Week 11 urinary cannabinoids [ng/ml]
|
376 urinary cannabinoids in ng/ml
Standard Error 86
|
—
|
|
Cannabis Use During Tobacco Cessation Treatment (Among Co-users)
Week 9 urinary cannabinoids [ng/ml]
|
405 urinary cannabinoids in ng/ml
Standard Error 96
|
—
|
|
Cannabis Use During Tobacco Cessation Treatment (Among Co-users)
Week 10 urinary cannabinoids [ng/ml]
|
402 urinary cannabinoids in ng/ml
Standard Error 98
|
—
|
|
Cannabis Use During Tobacco Cessation Treatment (Among Co-users)
Week 12 urinary cannabinoids [ng/ml]
|
414 urinary cannabinoids in ng/ml
Standard Error 88
|
—
|
Adverse Events
Co-Use Group
Serious events: 1 serious events
Other events: 76 other events
Deaths: 0 deaths
Tobacco Only Group
Serious events: 1 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Co-Use Group
n=110 participants at risk
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.
|
Tobacco Only Group
n=71 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Gastrointestinal Surgery
|
0.00%
0/110 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
|
Nervous system disorders
Altered State of Consciousness
|
0.91%
1/110 • Number of events 1 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
0.00%
0/71 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
Other adverse events
| Measure |
Co-Use Group
n=110 participants at risk
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.
|
Tobacco Only Group
n=71 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
28.2%
31/110 • Number of events 40 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
31.0%
22/71 • Number of events 27 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
|
General disorders
Irritability
|
9.1%
10/110 • Number of events 11 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
4.2%
3/71 • Number of events 3 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
|
Metabolism and nutrition disorders
Weight gain
|
0.91%
1/110 • Number of events 1 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
5.6%
4/71 • Number of events 4 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
|
Nervous system disorders
Headache
|
6.4%
7/110 • Number of events 8 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
8.5%
6/71 • Number of events 6 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
|
Nervous system disorders
Somnolence
|
3.6%
4/110 • Number of events 4 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
5.6%
4/71 • Number of events 4 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
|
Psychiatric disorders
Vivid Dreams
|
20.0%
22/110 • Number of events 24 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
32.4%
23/71 • Number of events 29 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
|
Psychiatric disorders
Depressed mood
|
5.5%
6/110 • Number of events 7 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
4.2%
3/71 • Number of events 3 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
|
Psychiatric disorders
Insomnia
|
5.5%
6/110 • Number of events 6 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
7.0%
5/71 • Number of events 7 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
|
Psychiatric disorders
Anxiety (Worsening)
|
5.5%
6/110 • Number of events 6 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
2.8%
2/71 • Number of events 5 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
|
Psychiatric disorders
Tobacco Withdrawal Symptoms
|
1.8%
2/110 • Number of events 2 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
5.6%
4/71 • Number of events 4 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
|
Psychiatric disorders
Vivid Dreams (Worsening)
|
4.5%
5/110 • Number of events 7 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
7.0%
5/71 • Number of events 5 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
|
Gastrointestinal disorders
Vomiting
|
5.5%
6/110 • Number of events 6 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected starting after study screening and up to 6 months following the screening assessment and through the Week 26 follow-up study visit.
Other non-serious adverse events that occured in greater than 5% of participants (in either experimental group) are reported here. Each adverse event was coded with a MedDRA term and the specific Adverse Event term is used.
|
Additional Information
Erin A. McClure, Principal Investigator
Medical University of South Carolina
Phone: 843-792-7192
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place