Trial Outcomes & Findings for Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes (NCT NCT03612960)
NCT ID: NCT03612960
Last Updated: 2024-08-20
Results Overview
Change from baseline to 6-weeks post-intervention in percentage of BOLD signal during hard vs. no choice conditions on a monetary delay discounting task in a left-sided cortical brain region encompassing the central opercular and dorsolateral prefrontal cortices.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
Change in BOLD signal from baseline to the 6-week visit.
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Very Low Nicotine Content Cigarettes
Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.
|
Normal Nicotine Content Cigarettes
Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
13
|
|
Overall Study
COMPLETED
|
20
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes
Baseline characteristics by cohort
| Measure |
Very Low Nicotine Content Cigarettes
n=21 Participants
Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.
|
Normal Nicotine Content Cigarettes
n=13 Participants
Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.90 years
STANDARD_DEVIATION 7.98 • n=5 Participants
|
44.46 years
STANDARD_DEVIATION 8.69 • n=7 Participants
|
43.50 years
STANDARD_DEVIATION 8.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
13 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Cigarettes per day (CPD)
|
18.90 cigarettes per day
STANDARD_DEVIATION 7.35 • n=5 Participants
|
14.46 cigarettes per day
STANDARD_DEVIATION 5.39 • n=7 Participants
|
17.21 cigarettes per day
STANDARD_DEVIATION 7.01 • n=5 Participants
|
|
Menthol vs Non-Menthol
Menthol
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Menthol vs Non-Menthol
Non-Menthol
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Cigarette Dependence
|
4.10 units on a scale
STANDARD_DEVIATION 1.22 • n=5 Participants
|
3.77 units on a scale
STANDARD_DEVIATION 1.09 • n=7 Participants
|
3.97 units on a scale
STANDARD_DEVIATION 1.17 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change in BOLD signal from baseline to the 6-week visit.Population: Only participants who completed the baseline and post-randomization laboratory visits were included in the analysis.
Change from baseline to 6-weeks post-intervention in percentage of BOLD signal during hard vs. no choice conditions on a monetary delay discounting task in a left-sided cortical brain region encompassing the central opercular and dorsolateral prefrontal cortices.
Outcome measures
| Measure |
Very Low Nicotine Content Cigarettes
n=20 Participants
Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.
Very low nicotine content cigarettes: Very low nicotine content cigarettes
|
Normal Nicotine Content Cigarettes
n=10 Participants
Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.
Normal nicotine content cigarettes: Normal nicotine content cigarettes
|
|---|---|---|
|
Change in Blood Oxygen Level Dependent (BOLD) Signal Collected by Functional Magnetic Resonance Imaging (fMRI) During Monetary Delay Discounting Task
|
0.13 Percent change
Standard Deviation 0.18
|
-0.16 Percent change
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: Average cigarettes per day during week 1 subtracted from average cigarettes per day during week 6.Difference in week 6 mean minus week 1 mean of cigarettes used per day reported by participants on daily logs.
Outcome measures
| Measure |
Very Low Nicotine Content Cigarettes
n=20 Participants
Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.
Very low nicotine content cigarettes: Very low nicotine content cigarettes
|
Normal Nicotine Content Cigarettes
n=10 Participants
Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.
Normal nicotine content cigarettes: Normal nicotine content cigarettes
|
|---|---|---|
|
Change in Self-reported Cigarettes Per Day
|
-5.1 Number of cigarettes per day
Standard Deviation 7.9
|
3.3 Number of cigarettes per day
Standard Deviation 16.0
|
SECONDARY outcome
Timeframe: Changes from baseline to 6-weeks post intervention.Population: Participants who completed both trial laboratory visits were included in the analysis.
A difference score (6-weeks minus baseline) of the percentage of trials where the immediate (vs. delayed) monetary option was chosen out of all task trials during the monetary delay discounting task that was completed outside of the MRI scan.
Outcome measures
| Measure |
Very Low Nicotine Content Cigarettes
n=20 Participants
Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.
Very low nicotine content cigarettes: Very low nicotine content cigarettes
|
Normal Nicotine Content Cigarettes
n=10 Participants
Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.
Normal nicotine content cigarettes: Normal nicotine content cigarettes
|
|---|---|---|
|
Change in Percentage of Immediate Choices on Monetary Delay Discounting Task
|
0.20 Change in percentage
Standard Deviation 30.26
|
1.57 Change in percentage
Standard Deviation 9.16
|
Adverse Events
Very Low Nicotine Content Cigarettes
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Normal Nicotine Content Cigarettes
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Very Low Nicotine Content Cigarettes
n=21 participants at risk
Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.
|
Normal Nicotine Content Cigarettes
n=13 participants at risk
Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fractured Finger
|
0.00%
0/21 • 3 years, 4 months
|
7.7%
1/13 • Number of events 1 • 3 years, 4 months
|
|
Gastrointestinal disorders
Nausea and Headaches
|
4.8%
1/21 • Number of events 1 • 3 years, 4 months
|
0.00%
0/13 • 3 years, 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place