Trial Outcomes & Findings for Effects of Smoking Environments on Craving and Smoking (CameraCue2.0) (NCT NCT02551692)
NCT ID: NCT02551692
Last Updated: 2020-01-18
Results Overview
Scores range from 0 (no craving) to 100 (extreme craving).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
125 participants
Primary outcome timeframe
Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)
Results posted on
2020-01-18
Participant Flow
37 participants were withdrawn from the study prior to treatment assignment due to either loss of interest, lost to contact, or inability to complete baseline procedures per protocol.
Participant milestones
| Measure |
Placebo (PLAC)
Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.
|
Transdermal Nicotine Patch (NRT)
Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the NRT group, participants will take a placebo capsule while wearing nicotine patches.
|
Varenicline (VAR)
Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the VAR group, participants will wear a placebo patch while taking varenicline.
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
27
|
30
|
|
Overall Study
COMPLETED
|
30
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
5
|
Reasons for withdrawal
| Measure |
Placebo (PLAC)
Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.
|
Transdermal Nicotine Patch (NRT)
Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the NRT group, participants will take a placebo capsule while wearing nicotine patches.
|
Varenicline (VAR)
Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the VAR group, participants will wear a placebo patch while taking varenicline.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
Baseline Characteristics
Effects of Smoking Environments on Craving and Smoking (CameraCue2.0)
Baseline characteristics by cohort
| Measure |
Placebo (PLAC)
n=31 Participants
Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.
|
Transdermal Nicotine Patch (NRT)
n=27 Participants
Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the NRT group, participants will take a placebo capsule while wearing nicotine patches.
|
Varenicline (VAR)
n=30 Participants
Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the VAR group, participants will wear a placebo patch while taking varenicline.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
41.2 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
44.4 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)Population: Subjects who completed the study.
Scores range from 0 (no craving) to 100 (extreme craving).
Outcome measures
| Measure |
Placebo (PLAC)
n=30 Participants
Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.
|
Transdermal Nicotine Patch (NRT)
n=26 Participants
Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the NRT group, participants will take a placebo capsule while wearing nicotine patches.
|
Varenicline (VAR)
n=25 Participants
Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the VAR group, participants will wear a placebo patch while taking varenicline.
|
|---|---|---|---|
|
Change in Craving Score During Cue Exposure Task
|
-11.17 score on a scale
Standard Deviation 24.93
|
-8.84 score on a scale
Standard Deviation 28.3
|
-14.29 score on a scale
Standard Deviation 25.09
|
PRIMARY outcome
Timeframe: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)Population: Subjects who completed the study.
The latency is the interval between smoking one cigarette and wanting, craving, or needing another.
Outcome measures
| Measure |
Placebo (PLAC)
n=30 Participants
Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.
|
Transdermal Nicotine Patch (NRT)
n=26 Participants
Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the NRT group, participants will take a placebo capsule while wearing nicotine patches.
|
Varenicline (VAR)
n=25 Participants
Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the VAR group, participants will wear a placebo patch while taking varenicline.
|
|---|---|---|---|
|
Change in Latency to Smoke During Cue Exposure Task
|
30.22 seconds
Standard Deviation 71.58
|
48.04 seconds
Standard Deviation 95.79
|
65.15 seconds
Standard Deviation 133.12
|
PRIMARY outcome
Timeframe: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)Population: Subjects who completed the study.
Measured by number of puffs.
Outcome measures
| Measure |
Placebo (PLAC)
n=30 Participants
Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.
|
Transdermal Nicotine Patch (NRT)
n=26 Participants
Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the NRT group, participants will take a placebo capsule while wearing nicotine patches.
|
Varenicline (VAR)
n=25 Participants
Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the VAR group, participants will wear a placebo patch while taking varenicline.
|
|---|---|---|---|
|
Change in Smoke Intake During Cue Exposure Task
|
14.42 puffs
Standard Deviation 6.35
|
12.21 puffs
Standard Deviation 4.42
|
12.98 puffs
Standard Deviation 7.90
|
Adverse Events
Placebo (PLAC)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Transdermal Nicotine Patch (NRT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Varenicline (VAR)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (PLAC)
n=31 participants at risk
Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.
|
Transdermal Nicotine Patch (NRT)
n=27 participants at risk
Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the NRT group, participants will take a placebo capsule while wearing nicotine patches.
|
Varenicline (VAR)
n=30 participants at risk
Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the VAR group, participants will wear a placebo patch while taking varenicline.
|
|---|---|---|---|
|
Infections and infestations
Bacterial blood infection
|
3.2%
1/31 • 3 weeks
|
0.00%
0/27 • 3 weeks
|
0.00%
0/30 • 3 weeks
|
|
Renal and urinary disorders
Blood in urine
|
3.2%
1/31 • 3 weeks
|
0.00%
0/27 • 3 weeks
|
0.00%
0/30 • 3 weeks
|
|
General disorders
Dehydration
|
3.2%
1/31 • 3 weeks
|
0.00%
0/27 • 3 weeks
|
0.00%
0/30 • 3 weeks
|
|
Infections and infestations
Kidney infection
|
3.2%
1/31 • 3 weeks
|
0.00%
0/27 • 3 weeks
|
0.00%
0/30 • 3 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place