Trial Outcomes & Findings for A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV (NCT NCT04490057)
NCT ID: NCT04490057
Last Updated: 2026-01-05
Results Overview
Self reported reduction in average cigarettes smoked per day at 12 weeks
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
323 participants
Primary outcome timeframe
Week 12
Results posted on
2026-01-05
Participant Flow
Participants were consented, completed baseline and randomized to one of 2 arms in Stage 1: nicotine replacement therapy (NRT) or NRT+ CM (contingency management). At week 12, participants who were abstinent remained in their original arm. Participants who were not abstinent were re-randomized. If NRT in Stage 1, re-randomized to NRT+CM or varenicline (VAR). If NRT+CM Stage 1, re-randomized to NRT+CM intensified or VAR+CM.
Participant milestones
| Measure |
Stage 1: NRT
Stage 1: participants randomized to receive nicotine replacement therapy only in Weeks 0-12
|
Stage 1: NRT+CM
Participants randomized to receive nicotine replacement therapy and contingency management (Weeks 0-12)
|
Stage 2: NRT Responders
Responders from Stage 1 remain on nicotine replacement therapy for Stage 2
|
Stage 2: Varenicline or Bupropion
Non-responders to NRT in Stage 1 were switched to varenicline or bupropion alone for second 12 weeks (Stage 2).
|
Stage 2: NRT+CM
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
|
Stage 2: NRT+CM Responders
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
|
Stage 2: Varenicline or Bupropion + CM
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
|
Stage 2: NRT+CM Plus
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1
STARTED
|
163
|
160
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
COMPLETED
|
160
|
158
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
NOT COMPLETED
|
3
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
STARTED
|
0
|
0
|
16
|
70
|
74
|
36
|
60
|
62
|
|
Stage 2
COMPLETED
|
0
|
0
|
16
|
59
|
56
|
32
|
39
|
48
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
11
|
18
|
4
|
21
|
14
|
Reasons for withdrawal
| Measure |
Stage 1: NRT
Stage 1: participants randomized to receive nicotine replacement therapy only in Weeks 0-12
|
Stage 1: NRT+CM
Participants randomized to receive nicotine replacement therapy and contingency management (Weeks 0-12)
|
Stage 2: NRT Responders
Responders from Stage 1 remain on nicotine replacement therapy for Stage 2
|
Stage 2: Varenicline or Bupropion
Non-responders to NRT in Stage 1 were switched to varenicline or bupropion alone for second 12 weeks (Stage 2).
|
Stage 2: NRT+CM
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
|
Stage 2: NRT+CM Responders
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
|
Stage 2: Varenicline or Bupropion + CM
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
|
Stage 2: NRT+CM Plus
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).
|
|---|---|---|---|---|---|---|---|---|
|
Stage 1
Death
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 1
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage 2
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Stage 2
Lost to Follow-up
|
0
|
0
|
0
|
11
|
17
|
4
|
21
|
14
|
Baseline Characteristics
eCO was not collected for 5 participants at baseline due to staff error.
Baseline characteristics by cohort
| Measure |
Stage 1: Nicotine Replacement Only (NRT)
n=163 Participants
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement therapy prescriptions and tobacco cessation counseling
|
Stage 1: Nicotine Replacement (NRT) + Contingency Management (CM)
n=160 Participants
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement (NRT) prescriptions and tobacco cessation counseling. Participants in the NRT+CM arm also had the opportunity to earn prizes (gift cards) for tobacco abstinence, verified by exhaled carbon monoxide or next closest informant verification.
|
Total
n=323 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
92 Participants
n=163 Participants
|
89 Participants
n=160 Participants
|
181 Participants
n=323 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=163 Participants
|
71 Participants
n=160 Participants
|
142 Participants
n=323 Participants
|
|
Age, Continuous
|
55.71 years
STANDARD_DEVIATION 10.8 • n=163 Participants
|
54.42 years
STANDARD_DEVIATION 10.6 • n=160 Participants
|
55.08 years
STANDARD_DEVIATION 10.71 • n=323 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=163 Participants
|
3 Participants
n=160 Participants
|
8 Participants
n=323 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=163 Participants
|
1 Participants
n=160 Participants
|
1 Participants
n=323 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=163 Participants
|
1 Participants
n=160 Participants
|
1 Participants
n=323 Participants
|
|
Race (NIH/OMB)
Black or African American
|
116 Participants
n=163 Participants
|
114 Participants
n=160 Participants
|
230 Participants
n=323 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=163 Participants
|
33 Participants
n=160 Participants
|
62 Participants
n=323 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=163 Participants
|
6 Participants
n=160 Participants
|
15 Participants
n=323 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
6 Participants
n=323 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=163 Participants
|
42 Participants
n=160 Participants
|
74 Participants
n=323 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
130 Participants
n=163 Participants
|
118 Participants
n=160 Participants
|
248 Participants
n=323 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
1 Participants
n=323 Participants
|
|
Region of Enrollment
United States
|
163 Participants
n=163 Participants
|
160 Participants
n=160 Participants
|
323 Participants
n=323 Participants
|
|
Cigarettes per day
|
10.0 cigarettes per day
n=163 Participants
|
10.0 cigarettes per day
n=160 Participants
|
10.0 cigarettes per day
n=323 Participants
|
|
Exhaled carbon monoxide at baseline
|
10.0 parts per million (ppm)
n=159 Participants • eCO was not collected for 5 participants at baseline due to staff error.
|
10.0 parts per million (ppm)
n=159 Participants • eCO was not collected for 5 participants at baseline due to staff error.
|
10.0 parts per million (ppm)
n=318 Participants • eCO was not collected for 5 participants at baseline due to staff error.
|
|
VACS 2.0 score
|
45.0 score on a scale
n=159 Participants • 8 participants were missing a lab value required to calculate VACS 2.0
|
42.0 score on a scale
n=156 Participants • 8 participants were missing a lab value required to calculate VACS 2.0
|
43.0 score on a scale
n=315 Participants • 8 participants were missing a lab value required to calculate VACS 2.0
|
|
HIV viral load, detectable
Viral load detectable
|
19 Participants
n=162 Participants • HIV viral load was not available at baseline for 3 participants
|
17 Participants
n=158 Participants • HIV viral load was not available at baseline for 3 participants
|
36 Participants
n=320 Participants • HIV viral load was not available at baseline for 3 participants
|
|
HIV viral load, detectable
Viral load not detectable
|
143 Participants
n=162 Participants • HIV viral load was not available at baseline for 3 participants
|
141 Participants
n=158 Participants • HIV viral load was not available at baseline for 3 participants
|
284 Participants
n=320 Participants • HIV viral load was not available at baseline for 3 participants
|
|
CD4 cell count
|
600.0 cells per cubic millimeter
n=162 Participants • CD4 count was not available for 1 participant at baseline
|
596.5 cells per cubic millimeter
n=160 Participants • CD4 count was not available for 1 participant at baseline
|
596.5 cells per cubic millimeter
n=322 Participants • CD4 count was not available for 1 participant at baseline
|
PRIMARY outcome
Timeframe: Week 12Self reported reduction in average cigarettes smoked per day at 12 weeks
Outcome measures
| Measure |
Stage 1: Nicotine Replacement only (NRT)
n=163 Participants
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement therapy prescriptions and tobacco cessation counseling
|
Stage 1: Nicotine Replacement (NRT) + Contingency Management (CM)
n=160 Participants
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement (NRT) prescriptions and tobacco cessation counseling. Participants in the NRT+CM arm also had the opportunity to earn prizes (gift cards) for tobacco abstinence, verified by exhaled carbon monoxide or next closest informant verification.
|
Stage 2: NRT+CM
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
|
Stage 2: NRT+CM responders
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
|
Stage 2: varenicline or bupropion + CM
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
|
Stage 2: NRT+CM plus
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).
|
|---|---|---|---|---|---|---|
|
Self Reported Reduction in Average Cigarettes Smoked Per Day at 12 Weeks
|
5.2 cigarettes per day
Interval 3.9 to 6.5
|
4.9 cigarettes per day
Interval 3.5 to 6.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 weeksSelf reported reduction in cigarettes smoked per day at 24 weeks
Outcome measures
| Measure |
Stage 1: Nicotine Replacement only (NRT)
n=16 Participants
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement therapy prescriptions and tobacco cessation counseling
|
Stage 1: Nicotine Replacement (NRT) + Contingency Management (CM)
n=59 Participants
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement (NRT) prescriptions and tobacco cessation counseling. Participants in the NRT+CM arm also had the opportunity to earn prizes (gift cards) for tobacco abstinence, verified by exhaled carbon monoxide or next closest informant verification.
|
Stage 2: NRT+CM
n=56 Participants
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
|
Stage 2: NRT+CM responders
n=32 Participants
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
|
Stage 2: varenicline or bupropion + CM
n=39 Participants
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
|
Stage 2: NRT+CM plus
n=48 Participants
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).
|
|---|---|---|---|---|---|---|
|
Self Reported Reduction in Average Cigarettes Smoked Per Day at 24 Weeks
|
7.90 cigarettes per day
Interval 4.355 to 11.44
|
6.23 cigarettes per day
Interval 4.45 to 8.02
|
2.97 cigarettes per day
Interval 1.5 to 4.44
|
10.92 cigarettes per day
Interval 8.4 to 13.43
|
4.00 cigarettes per day
Interval 2.48 to 5.52
|
4.20 cigarettes per day
Interval 2.6 to 5.8
|
SECONDARY outcome
Timeframe: 12 weeks from baselineNumber of participants with smoking abstinence confirmed by exhaled carbon monoxide or next closest informant verification
Outcome measures
| Measure |
Stage 1: Nicotine Replacement only (NRT)
n=163 Participants
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement therapy prescriptions and tobacco cessation counseling
|
Stage 1: Nicotine Replacement (NRT) + Contingency Management (CM)
n=160 Participants
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement (NRT) prescriptions and tobacco cessation counseling. Participants in the NRT+CM arm also had the opportunity to earn prizes (gift cards) for tobacco abstinence, verified by exhaled carbon monoxide or next closest informant verification.
|
Stage 2: NRT+CM
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
|
Stage 2: NRT+CM responders
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
|
Stage 2: varenicline or bupropion + CM
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
|
Stage 2: NRT+CM plus
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).
|
|---|---|---|---|---|---|---|
|
Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 12 Weeks
|
16 Participants
Interval 3.3 to 18.7
|
36 Participants
Interval 9.8 to 36.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeks from baselineNumber of participants with smoking abstinence confirmed by exhaled carbon monoxide or next closest informant verification
Outcome measures
| Measure |
Stage 1: Nicotine Replacement only (NRT)
n=16 Participants
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement therapy prescriptions and tobacco cessation counseling
|
Stage 1: Nicotine Replacement (NRT) + Contingency Management (CM)
n=59 Participants
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement (NRT) prescriptions and tobacco cessation counseling. Participants in the NRT+CM arm also had the opportunity to earn prizes (gift cards) for tobacco abstinence, verified by exhaled carbon monoxide or next closest informant verification.
|
Stage 2: NRT+CM
n=56 Participants
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
|
Stage 2: NRT+CM responders
n=32 Participants
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
|
Stage 2: varenicline or bupropion + CM
n=39 Participants
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
|
Stage 2: NRT+CM plus
n=48 Participants
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).
|
|---|---|---|---|---|---|---|
|
Exhaled Carbon Monoxide (eCO) Confirmed Smoking Abstinence at 24 Weeks
|
4 Participants
Interval 4.55 to 59.91
|
6 Participants
Interval 4.58 to 32.82
|
7 Participants
Interval 6.43 to 32.21
|
23 Participants
Interval 47.77 to 89.36
|
3 Participants
Interval 11.58 to 48.44
|
8 Participants
Interval 15.61 to 53.04
|
SECONDARY outcome
Timeframe: 24 weeks from baselinePopulation: Lab results were collected for all participants at Week 24 including those who did not complete the Week 24 assessment battery.
The Veterans Aging Cohort Study (VACS) 2.0 Index is A validated measure of morbidity and mortality. It estimates risk of 5-year all-cause mortality in patients with HIV. Total score range of 0-129. A higher total score indicates a greater risk of adverse health outcomes.
Outcome measures
| Measure |
Stage 1: Nicotine Replacement only (NRT)
n=16 Participants
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement therapy prescriptions and tobacco cessation counseling
|
Stage 1: Nicotine Replacement (NRT) + Contingency Management (CM)
n=70 Participants
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement (NRT) prescriptions and tobacco cessation counseling. Participants in the NRT+CM arm also had the opportunity to earn prizes (gift cards) for tobacco abstinence, verified by exhaled carbon monoxide or next closest informant verification.
|
Stage 2: NRT+CM
n=69 Participants
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
|
Stage 2: NRT+CM responders
n=34 Participants
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
|
Stage 2: varenicline or bupropion + CM
n=59 Participants
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
|
Stage 2: NRT+CM plus
n=60 Participants
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).
|
|---|---|---|---|---|---|---|
|
VACS Index 2.0 Score
|
42.88 score on a scale
Standard Deviation 15.09
|
47.26 score on a scale
Standard Deviation 17.61
|
49.42 score on a scale
Standard Deviation 19.61
|
42.65 score on a scale
Standard Deviation 15.38
|
42.66 score on a scale
Standard Deviation 15.66
|
43.63 score on a scale
Standard Deviation 15.70
|
SECONDARY outcome
Timeframe: 24 weeks from baselinePopulation: Lab results were collected for all participants at Week 24 including those who did not complete the Week 24 assessment battery.
CD4 lymphocyte cell count. Normal range is 500-1200 cells per cubic millimeter. As HIV infection progresses, CD4 count drops.
Outcome measures
| Measure |
Stage 1: Nicotine Replacement only (NRT)
n=16 Participants
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement therapy prescriptions and tobacco cessation counseling
|
Stage 1: Nicotine Replacement (NRT) + Contingency Management (CM)
n=70 Participants
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement (NRT) prescriptions and tobacco cessation counseling. Participants in the NRT+CM arm also had the opportunity to earn prizes (gift cards) for tobacco abstinence, verified by exhaled carbon monoxide or next closest informant verification.
|
Stage 2: NRT+CM
n=69 Participants
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
|
Stage 2: NRT+CM responders
n=35 Participants
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
|
Stage 2: varenicline or bupropion + CM
n=59 Participants
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
|
Stage 2: NRT+CM plus
n=60 Participants
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).
|
|---|---|---|---|---|---|---|
|
CD4 Count
|
668.00 Cells per cubic millimeter
Standard Deviation 384.08
|
576.53 Cells per cubic millimeter
Standard Deviation 347.76
|
648.38 Cells per cubic millimeter
Standard Deviation 423.08
|
640.57 Cells per cubic millimeter
Standard Deviation 370.12
|
724.92 Cells per cubic millimeter
Standard Deviation 521.86
|
696.97 Cells per cubic millimeter
Standard Deviation 421.36
|
SECONDARY outcome
Timeframe: 24 weeks from baselinePopulation: Lab results were collected for all participants at Week 24 including those who did not complete the Week 24 assessment battery.
HIV viral load greater than 200 copies per milliliter of blood and detectable on standard lab test
Outcome measures
| Measure |
Stage 1: Nicotine Replacement only (NRT)
n=15 Participants
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement therapy prescriptions and tobacco cessation counseling
|
Stage 1: Nicotine Replacement (NRT) + Contingency Management (CM)
n=70 Participants
Participants met with a clinical pharmacist 6 times (baseline visit plus 5 follow-up visits) for nicotine replacement (NRT) prescriptions and tobacco cessation counseling. Participants in the NRT+CM arm also had the opportunity to earn prizes (gift cards) for tobacco abstinence, verified by exhaled carbon monoxide or next closest informant verification.
|
Stage 2: NRT+CM
n=74 Participants
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
|
Stage 2: NRT+CM responders
n=34 Participants
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
|
Stage 2: varenicline or bupropion + CM
n=60 Participants
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
|
Stage 2: NRT+CM plus
n=62 Participants
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).
|
|---|---|---|---|---|---|---|
|
HIV Viral Load, Detectable
|
0 Participants
|
10 Participants
|
14 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
Adverse Events
Stage 1: NRT
Serious events: 13 serious events
Other events: 6 other events
Deaths: 1 deaths
Stage 1: NRT+CM
Serious events: 9 serious events
Other events: 14 other events
Deaths: 2 deaths
Stage 2: NRT Responders
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2: Varenicline or Bupropion
Serious events: 5 serious events
Other events: 2 other events
Deaths: 0 deaths
Stage 2: NRT+CM
Serious events: 4 serious events
Other events: 0 other events
Deaths: 1 deaths
Stage 2: NRT+CM Responders
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Stage 2: Varenicline or Bupropion + CM
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 2: NRT+CM Plus
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1: NRT
n=163 participants at risk
Stage 1: participants randomized to receive nicotine replacement therapy only in Weeks 0-12
|
Stage 1: NRT+CM
n=160 participants at risk
Participants randomized to receive nicotine replacement therapy and contingency management (Weeks 0-12)
|
Stage 2: NRT Responders
n=16 participants at risk
Responders from Stage 1 remain on nicotine replacement therapy for Stage 2
|
Stage 2: Varenicline or Bupropion
n=70 participants at risk
Non-responders to NRT in Stage 1 were switched to varenicline or bupropion alone for second 12 weeks (Stage 2).
|
Stage 2: NRT+CM
n=74 participants at risk
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
|
Stage 2: NRT+CM Responders
n=36 participants at risk
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
|
Stage 2: Varenicline or Bupropion + CM
n=60 participants at risk
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
|
Stage 2: NRT+CM Plus
n=62 participants at risk
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal (nausea, diarrhea, abdominal pain)
|
1.2%
2/163 • Number of events 2 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/160 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.4%
1/70 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/74 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/60 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/62 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Nervous system disorders
Headache
|
0.61%
1/163 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/160 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/70 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/74 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.7%
1/60 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/62 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Infections and infestations
Infection - pathogen unspecified
|
0.61%
1/163 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.62%
1/160 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
2.9%
2/70 • Number of events 2 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/74 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/60 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/62 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint pain or connective tissue disorder
|
0.00%
0/163 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/160 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/70 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/74 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
2.8%
1/36 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/60 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/62 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Hepatobiliary disorders
Liver injury or dysfunction
|
0.00%
0/163 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/160 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.4%
1/70 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/74 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/60 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/62 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Nervous system disorders
Neurological disorders (sedation, lethargy, dizziness)
|
2.5%
4/163 • Number of events 4 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/160 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
6.2%
1/16 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/70 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/74 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.7%
1/60 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/62 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorders including pneumonia
|
1.8%
3/163 • Number of events 3 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.2%
2/160 • Number of events 2 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.4%
1/70 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.4%
1/74 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.7%
1/60 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
3.2%
2/62 • Number of events 2 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Psychiatric disorders
Altered mental status
|
0.61%
1/163 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.62%
1/160 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/70 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/74 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/60 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/62 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Social circumstances
Alcohol withdrawal
|
0.61%
1/163 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.62%
1/160 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/70 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.4%
1/74 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/60 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/62 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Renal and urinary disorders
Kidney injury
|
0.61%
1/163 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.62%
1/160 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/70 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.4%
1/74 • Number of events 5 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/60 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/62 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Social circumstances
Other
|
0.61%
1/163 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.2%
2/160 • Number of events 2 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/70 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/74 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/60 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.6%
1/62 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Psychiatric disorders
Suicidality
|
0.00%
0/163 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.2%
2/160 • Number of events 2 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/70 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/74 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.7%
1/60 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/62 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Cardiac disorders
Cardiac illness or injury
|
0.00%
0/163 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/160 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/70 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.4%
1/74 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/60 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/62 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
Other adverse events
| Measure |
Stage 1: NRT
n=163 participants at risk
Stage 1: participants randomized to receive nicotine replacement therapy only in Weeks 0-12
|
Stage 1: NRT+CM
n=160 participants at risk
Participants randomized to receive nicotine replacement therapy and contingency management (Weeks 0-12)
|
Stage 2: NRT Responders
n=16 participants at risk
Responders from Stage 1 remain on nicotine replacement therapy for Stage 2
|
Stage 2: Varenicline or Bupropion
n=70 participants at risk
Non-responders to NRT in Stage 1 were switched to varenicline or bupropion alone for second 12 weeks (Stage 2).
|
Stage 2: NRT+CM
n=74 participants at risk
Non-responders to NRT in Stage 1 were intensified to nicotine replacement therapy combined with contingency management for second 12 weeks (Stage 2).
|
Stage 2: NRT+CM Responders
n=36 participants at risk
Responders to NRT+CM in Stage 1 remain on same treatment for second 12 weeks (Stage 2).
|
Stage 2: Varenicline or Bupropion + CM
n=60 participants at risk
Non-responders NRT+CM in Stage 1 were switched to varenicline or bupropion combined with contingency management for second 12 weeks (Stage 2)
|
Stage 2: NRT+CM Plus
n=62 participants at risk
Non-responders to NRT+CM in Stage 1 were switched to nicotine replacement therapy combined with intensified contingency management for second 12 weeks (Stage 2).
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorders including pneumonia
|
0.00%
0/163 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.2%
2/160 • Number of events 2 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/70 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/74 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/60 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.6%
1/62 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Product Issues
Reaction to nicotine replacement therapy
|
0.61%
1/163 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
3.8%
6/160 • Number of events 6 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/70 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/74 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/60 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/62 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/163 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.62%
1/160 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/70 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/74 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/60 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.6%
1/62 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Psychiatric disorders
Psychiatric issues
|
0.61%
1/163 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/160 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/70 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/74 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/60 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/62 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Cardiac disorders
Cardiac illness or injury
|
0.00%
0/163 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.2%
2/160 • Number of events 2 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/70 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/74 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.7%
1/60 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/62 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/163 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.2%
2/160 • Number of events 2 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.4%
1/70 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/74 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
2.8%
1/36 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/60 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/62 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Hepatobiliary disorders
Liver injury or dysfunction
|
0.61%
1/163 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/160 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/70 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/74 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/60 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/62 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
|
Gastrointestinal disorders
Gastrointestinal Gastrointestinal (nausea, diarrhea, abdominal pain)
|
1.8%
3/163 • Number of events 3 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.2%
2/160 • Number of events 2 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/16 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
1.4%
1/70 • Number of events 1 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/74 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/36 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
3.3%
2/60 • Number of events 2 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
0.00%
0/62 • Stage 1: up to 12 weeks; Stage 2: up to 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place