Trial Outcomes & Findings for Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO) (NCT NCT03722966)
NCT ID: NCT03722966
Last Updated: 2024-02-06
Results Overview
Self-reported abstinence over the prior 7-days with a carbon monoxide value \<7 ppm (in exhaled breath) at 12 weeks post-quit date
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
12 weeks post-quit date
Results posted on
2024-02-06
Participant Flow
Participant milestones
| Measure |
Varenicline/Counseling + Med Reminders (VAR+REM)
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, and automated medication reminders via their smartphones.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Medication Reminders: Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + No Reminders (VAR+NREM)
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, and no automated medication reminders.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + Oral NRT + No Reminders (VAR+NRT+NREM)
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, 12 weeks of oral nicotine replacement therapy (NRT; gum or lozenge), and no automated medication reminders.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Oral Nicotine Replacement Therapy (NRT): Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + Oral NRT + Med Reminders (VAR+NRT+REM)
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, 12 weeks of oral nicotine replacement therapy (NRT; gum or lozenge), and automated medication reminders via their smartphones.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Oral Nicotine Replacement Therapy (NRT): Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline.
Medication Reminders: Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
12
|
11
|
9
|
|
Overall Study
COMPLETED
|
1
|
9
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)
Baseline characteristics by cohort
| Measure |
Varenicline/Counseling + Med Reminders (VAR+REM)
n=2 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, and automated medication reminders via their smartphones.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Medication Reminders: Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + No Reminders (VAR+NREM)
n=12 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, and no automated medication reminders.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + Oral NRT + No Reminders (VAR+NRT+NREM)
n=11 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, 12 weeks of oral nicotine replacement therapy (NRT; gum or lozenge), and no automated medication reminders.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Oral Nicotine Replacement Therapy (NRT): Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + Oral NRT + Med Reminders (VAR+NRT+REM)
n=9 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, 12 weeks of oral nicotine replacement therapy (NRT; gum or lozenge), and automated medication reminders via their smartphones.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Oral Nicotine Replacement Therapy (NRT): Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline.
Medication Reminders: Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.5 Years
STANDARD_DEVIATION 4.950 • n=5 Participants
|
50.75 Years
STANDARD_DEVIATION 9.016 • n=7 Participants
|
56.36 Years
STANDARD_DEVIATION 9.102 • n=5 Participants
|
54.56 Years
STANDARD_DEVIATION 10.608 • n=4 Participants
|
54.15 Years
STANDARD_DEVIATION 9.410 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
12 participants
n=7 Participants
|
11 participants
n=5 Participants
|
9 participants
n=4 Participants
|
34 participants
n=21 Participants
|
|
Cigarettes Smoked per Day
|
17.50 Cigarettes per day
STANDARD_DEVIATION 10.607 • n=5 Participants
|
16.42 Cigarettes per day
STANDARD_DEVIATION 5.316 • n=7 Participants
|
20.27 Cigarettes per day
STANDARD_DEVIATION 11.429 • n=5 Participants
|
21.11 Cigarettes per day
STANDARD_DEVIATION 10.105 • n=4 Participants
|
18.97 Cigarettes per day
STANDARD_DEVIATION 9.027 • n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post-quit dateSelf-reported abstinence over the prior 7-days with a carbon monoxide value \<7 ppm (in exhaled breath) at 12 weeks post-quit date
Outcome measures
| Measure |
Varenicline/Counseling + Med Reminders (VAR+REM)
n=2 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, and automated medication reminders via their smartphones.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Medication Reminders: Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + No Reminders (VAR+NREM)
n=12 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, and no automated medication reminders.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + Oral NRT + No Reminders (VAR+NRT+NREM)
n=11 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, 12 weeks of oral nicotine replacement therapy (NRT; gum or lozenge), and no automated medication reminders.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Oral Nicotine Replacement Therapy (NRT): Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + Oral NRT + Med Reminders (VAR+NRT+REM)
n=9 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, 12 weeks of oral nicotine replacement therapy (NRT; gum or lozenge), and automated medication reminders via their smartphones.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Oral Nicotine Replacement Therapy (NRT): Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline.
Medication Reminders: Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
|---|---|---|---|---|
|
Biochemically-Verified Smoking Cessation
|
1 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 26 weeks post-quit dateSelf-reported abstinence over the prior 7-days in conjunction with a carbon monoxide value \<7 ppm (in exhaled breath) at 26 weeks post-quit date
Outcome measures
| Measure |
Varenicline/Counseling + Med Reminders (VAR+REM)
n=2 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, and automated medication reminders via their smartphones.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Medication Reminders: Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + No Reminders (VAR+NREM)
n=12 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, and no automated medication reminders.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + Oral NRT + No Reminders (VAR+NRT+NREM)
n=11 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, 12 weeks of oral nicotine replacement therapy (NRT; gum or lozenge), and no automated medication reminders.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Oral Nicotine Replacement Therapy (NRT): Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + Oral NRT + Med Reminders (VAR+NRT+REM)
n=9 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, 12 weeks of oral nicotine replacement therapy (NRT; gum or lozenge), and automated medication reminders via their smartphones.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Oral Nicotine Replacement Therapy (NRT): Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline.
Medication Reminders: Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
|---|---|---|---|---|
|
Biochemically-Verified Smoking Cessation
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 week pre-quit though 12 weeks following a scheduled quit date (13 weeks)Total number of days of complete varenicline adherence from 1-week pre-quit through 12 weeks post-quit (91 days possible). Complete varenicline adherence was indicated when participants reported taking varenicline daily as prescribed.
Outcome measures
| Measure |
Varenicline/Counseling + Med Reminders (VAR+REM)
n=2 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, and automated medication reminders via their smartphones.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Medication Reminders: Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + No Reminders (VAR+NREM)
n=12 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, and no automated medication reminders.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + Oral NRT + No Reminders (VAR+NRT+NREM)
n=11 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, 12 weeks of oral nicotine replacement therapy (NRT; gum or lozenge), and no automated medication reminders.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Oral Nicotine Replacement Therapy (NRT): Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + Oral NRT + Med Reminders (VAR+NRT+REM)
n=9 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, 12 weeks of oral nicotine replacement therapy (NRT; gum or lozenge), and automated medication reminders via their smartphones.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Oral Nicotine Replacement Therapy (NRT): Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline.
Medication Reminders: Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
|---|---|---|---|---|
|
Varenicline Adherence
|
81.50 Days
Standard Deviation 0.71
|
45.58 Days
Standard Deviation 30.44
|
35.00 Days
Standard Deviation 34.74
|
53.44 Days
Standard Deviation 31.22
|
SECONDARY outcome
Timeframe: 12 weeks post-quit datePopulation: Participants in the VAR+ REM and VAR+NREM groups did not receive oral NRT and therefore do not have values.
Average daily pieces of gum/lozenges used over the first 12 weeks following a scheduled quit date.
Outcome measures
| Measure |
Varenicline/Counseling + Med Reminders (VAR+REM)
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, and automated medication reminders via their smartphones.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Medication Reminders: Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + No Reminders (VAR+NREM)
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, and no automated medication reminders.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + Oral NRT + No Reminders (VAR+NRT+NREM)
n=9 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, 12 weeks of oral nicotine replacement therapy (NRT; gum or lozenge), and no automated medication reminders.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Oral Nicotine Replacement Therapy (NRT): Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + Oral NRT + Med Reminders (VAR+NRT+REM)
n=9 Participants
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, 12 weeks of oral nicotine replacement therapy (NRT; gum or lozenge), and automated medication reminders via their smartphones.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Oral Nicotine Replacement Therapy (NRT): Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline.
Medication Reminders: Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
|---|---|---|---|---|
|
Oral NRT Adherence
|
—
|
—
|
7.44 Daily pieces of NRT used
Standard Deviation 9.80
|
14.00 Daily pieces of NRT used
Standard Deviation 15.57
|
Adverse Events
Varenicline/Counseling + Med Reminders (VAR+REM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Varenicline/Counseling (VAR+NREM)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Varenicline/Counseling + Oral NRT (VAR+NRT+NREM)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Varenicline/Counseling + Oral NRT + Med Reminders (VAR+NRT+REM)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Varenicline/Counseling + Med Reminders (VAR+REM)
n=2 participants at risk
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, and automated medication reminders via their smartphones.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Medication Reminders: Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling (VAR+NREM)
n=12 participants at risk
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, and no automated medication reminders.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + Oral NRT (VAR+NRT+NREM)
n=11 participants at risk
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, 12 weeks of oral nicotine replacement therapy (NRT; gum or lozenge), and no automated medication reminders.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Oral Nicotine Replacement Therapy (NRT): Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
Varenicline/Counseling + Oral NRT + Med Reminders (VAR+NRT+REM)
n=9 participants at risk
Participants will receive behavioral tobacco cessation counseling, a 13-week course of varenicline, 12 weeks of oral nicotine replacement therapy (NRT; gum or lozenge), and automated medication reminders via their smartphones.
Varenicline: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.
Oral Nicotine Replacement Therapy (NRT): Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline.
Medication Reminders: Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones.
Tobacco Cessation Counseling: All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
|
|---|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • 27 weeks (1-week pre-quit through 26 weeks post-quit)
|
25.0%
3/12 • Number of events 3 • 27 weeks (1-week pre-quit through 26 weeks post-quit)
|
27.3%
3/11 • Number of events 5 • 27 weeks (1-week pre-quit through 26 weeks post-quit)
|
33.3%
3/9 • Number of events 8 • 27 weeks (1-week pre-quit through 26 weeks post-quit)
|
|
Psychiatric disorders
Sleep Problems
|
0.00%
0/2 • 27 weeks (1-week pre-quit through 26 weeks post-quit)
|
0.00%
0/12 • 27 weeks (1-week pre-quit through 26 weeks post-quit)
|
18.2%
2/11 • Number of events 4 • 27 weeks (1-week pre-quit through 26 weeks post-quit)
|
0.00%
0/9 • 27 weeks (1-week pre-quit through 26 weeks post-quit)
|
|
Gastrointestinal disorders
Nausea with or without vomiting
|
0.00%
0/2 • 27 weeks (1-week pre-quit through 26 weeks post-quit)
|
8.3%
1/12 • Number of events 1 • 27 weeks (1-week pre-quit through 26 weeks post-quit)
|
18.2%
2/11 • Number of events 4 • 27 weeks (1-week pre-quit through 26 weeks post-quit)
|
0.00%
0/9 • 27 weeks (1-week pre-quit through 26 weeks post-quit)
|
Additional Information
Dr. Darla Kendzor
The University of Oklahoma Health Sciences Center
Phone: (405) 271-8001
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place