Trial Outcomes & Findings for Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging (NCT NCT01664741)
NCT ID: NCT01664741
Last Updated: 2019-05-09
Results Overview
BP provides an estimate of the product of the density of available receptors (Bmax' or the receptor density Bmax less those occupied by endogenous transmitters) and the affinity \[1/equilibrium dissociation constant (KD)\]. We use reference tissue graphical analysis (RTGA) to obtain regional BP values using occipital lobe as a reference region. Negative BP change means means a decrease in the BP and positive BP change means an increase in the BP.
COMPLETED
PHASE4
127 participants
90 minutes
2019-05-09
Participant Flow
102 of the participants who passed the on-phone screen came in and signed the consent form to be enrolled in the study. Baseline characteristics data was collected from them but they however failed an assessment done prior to getting the PET scan and so could not start the study.
Participant milestones
| Measure |
Nicotine Patch - Transdermal
21 mg nicotine patch
Nicotine patch - transdermal
|
Placebo NRT
Matching placebo patch
placebo
|
Healthy Non-smoker Comparison
Demographically-matched women and men who have never smoked
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
13
|
|
Overall Study
COMPLETED
|
6
|
6
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging
Baseline characteristics by cohort
| Measure |
Nicotine Patch - Transdermal
n=42 Participants
21 mg nicotine patch
Nicotine patch - transdermal
|
Placebo NRT
n=42 Participants
Matching placebo patch
placebo
|
Healthy Non-smoker Comparison
n=43 Participants
Demographically-matched women and men who have never smoked
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 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
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (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
|
|
Region of Enrollment
United States
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
|
Years of regular smoking
|
22.2 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
22.2 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
0 years
STANDARD_DEVIATION 0 • n=5 Participants
|
22.2 years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
|
Cigarettes per day
|
17.0 number of cigarettes/day
STANDARD_DEVIATION 6.9 • n=5 Participants
|
17.0 number of cigarettes/day
STANDARD_DEVIATION 6.9 • n=7 Participants
|
0 number of cigarettes/day
STANDARD_DEVIATION 0 • n=5 Participants
|
17.0 number of cigarettes/day
STANDARD_DEVIATION 6.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: 90 minutesBP provides an estimate of the product of the density of available receptors (Bmax' or the receptor density Bmax less those occupied by endogenous transmitters) and the affinity \[1/equilibrium dissociation constant (KD)\]. We use reference tissue graphical analysis (RTGA) to obtain regional BP values using occipital lobe as a reference region. Negative BP change means means a decrease in the BP and positive BP change means an increase in the BP.
Outcome measures
| Measure |
Nicotine Patch - Transdermal
n=6 Participants
21 mg nicotine patch
Nicotine patch - transdermal
|
Placebo NRT
n=6 Participants
Matching placebo patch
placebo
|
Healthy Non-smoker Comparison
n=13 Participants
Demographically-matched women and men who have never smoked
|
|---|---|---|---|
|
Change in Mu-opioid Receptor Binding Potential (BP) Between Baseline and Post-patch Scans
BP Change - Left Amygdala
|
-2.47 ratio
Standard Error 3.91
|
-5.94 ratio
Standard Error 3.91
|
5.60 ratio
Standard Error 2.66
|
|
Change in Mu-opioid Receptor Binding Potential (BP) Between Baseline and Post-patch Scans
BP Change - Ventral Striatum
|
-1.24 ratio
Standard Error 3.50
|
-9.25 ratio
Standard Error 3.50
|
0.59 ratio
Standard Error 2.38
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: This assessment was not done on the healthy non-smokers because they didn't have any nicotine craving.
Regression measure (β) between change in mu-opioid receptor binding potential between baseline scan and post-treatment scan in the left amygdala and mean Craving Visual Analog Scale score on Days 2 - 4 of the Clinical Research Unit stay. Craving visual analog scale ranges from 0 (not at all) to 20 (worst ever).
Outcome measures
| Measure |
Nicotine Patch - Transdermal
n=6 Participants
21 mg nicotine patch
Nicotine patch - transdermal
|
Placebo NRT
n=6 Participants
Matching placebo patch
placebo
|
Healthy Non-smoker Comparison
Demographically-matched women and men who have never smoked
|
|---|---|---|---|
|
Relationship Between Change in Mu-opioid Receptor Binding Potential and Visual Analog Craving Scale Score
|
0.556 unitless
|
-0.550 unitless
|
—
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: This assessment was not done on the healthy non-smokers because they didn't have any nicotine craving.
Regression measure (β) between change in mu-opioid receptor binding potential between baseline scan and post-treatment scan and mean Minnesota Nicotine Withdrawal Scale (MNWS) score on Days 2 - 4 of the Clinical Research Unit stay. The MNWS is a self-report measure that consists of 14 nicotine withdrawal symptoms each rated on a 0 - 4 response scale for severity over the past 24 hours. Higher scores are indicative of greater nicotine withdrawal severity.
Outcome measures
| Measure |
Nicotine Patch - Transdermal
n=6 Participants
21 mg nicotine patch
Nicotine patch - transdermal
|
Placebo NRT
n=6 Participants
Matching placebo patch
placebo
|
Healthy Non-smoker Comparison
Demographically-matched women and men who have never smoked
|
|---|---|---|---|
|
Relationship Between Change in Mu-opioid Receptor Binding Potential and Minnesota Nicotine Withdrawal Scale Score
Left Amygdala
|
-0.087 unitless
|
-0.836 unitless
|
—
|
|
Relationship Between Change in Mu-opioid Receptor Binding Potential and Minnesota Nicotine Withdrawal Scale Score
Ventral Striatum
|
0.419 unitless
|
-0.794 unitless
|
—
|
Adverse Events
Nicotine Patch - Transdermal
Placebo NRT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place