Trial Outcomes & Findings for Neurobehavioral Substrates of Propranolol's Effects on Drug Cue Reactivity (NCT NCT03309943)
NCT ID: NCT03309943
Last Updated: 2020-08-13
Results Overview
BOLD activation in amygdala (% Signal Change). These are analyzed as separate units for each Trial Type (6 total: Proximal Non-Smoking, Proximal Smoking, Standard Environment Non-Smoking, Standard Environment Smoking, Personal Environment Non-Smoking, personal Environment Smoking), MRI Run (4 total: The task was divided into 4 runs to allow for participant breaks) and Brain Hemisphere (2 total: Left and Right). These are only presented by trial type as MRI Run and Brain Hemisphere are not variables of interest.
COMPLETED
PHASE4
44 participants
MRI Scan: 2-3 hours post-administration
2020-08-13
Participant Flow
Participants were enrolled in a laboratory setting at Duke University School of Medicine during a period ranging from January 2018 to June 2019.
Participant milestones
| Measure |
Propranolol
Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions
Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
|
Placebo
Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions
Placebo: Participants will take one dose of Placebo on two separate occasions.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
22
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Propranolol
Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions
Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
|
Placebo
Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions
Placebo: Participants will take one dose of Placebo on two separate occasions.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Inappropriate behavior towards staff
|
0
|
1
|
Baseline Characteristics
Neurobehavioral Substrates of Propranolol's Effects on Drug Cue Reactivity
Baseline characteristics by cohort
| Measure |
Propranolol
n=22 Participants
Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions
Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
|
Placebo
n=20 Participants
Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions
Placebo: Participants will take one dose of Placebo on two separate occasions.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.6 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
35.0 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
36.3 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 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
|
1 Participants
n=7 Participants
|
1 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
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
|
Cigarettes Per Day
|
15.0 Cigarettes/day
STANDARD_DEVIATION 6.1 • n=5 Participants
|
15.4 Cigarettes/day
STANDARD_DEVIATION 7.3 • n=7 Participants
|
15.2 Cigarettes/day
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Fagerstrom Test for Cigarette Dependence
|
4.2 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 2.2 • n=7 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Contemplation Ladder (Motivation to Quit)
|
4.9 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 2.9 • n=7 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Number of Previous Quit Attempts
|
2.5 quit-attempts
STANDARD_DEVIATION 2.3 • n=5 Participants
|
2.0 quit-attempts
STANDARD_DEVIATION 1.6 • n=7 Participants
|
2.2 quit-attempts
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Education
Education <= High School Diploma
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Education
Education > High School Diploma
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Income
Usual Annual Income < $30,000
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Income
Usual Annual income >= $30,000
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: MRI Scan: 2-3 hours post-administrationPopulation: Participants who completed the study. Excludes two additional participants in the placebo condition who had excessive motion artifact during scanning and could not be included in neuroimaging analyses.
BOLD activation in amygdala (% Signal Change). These are analyzed as separate units for each Trial Type (6 total: Proximal Non-Smoking, Proximal Smoking, Standard Environment Non-Smoking, Standard Environment Smoking, Personal Environment Non-Smoking, personal Environment Smoking), MRI Run (4 total: The task was divided into 4 runs to allow for participant breaks) and Brain Hemisphere (2 total: Left and Right). These are only presented by trial type as MRI Run and Brain Hemisphere are not variables of interest.
Outcome measures
| Measure |
Propranolol
n=1056 Trial Type, MRI Run, Brain Hemisphere
Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions
Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
|
Placebo
n=864 Trial Type, MRI Run, Brain Hemisphere
Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions
Placebo: Participants will take one dose of Placebo on two separate occasions.
|
|---|---|---|
|
BOLD Activation to Smoking Cues - Amygdala
Non-Smoking Personal Environments
|
0.002471 Percent Signal Change
Standard Deviation 0.367038
|
0.077325 Percent Signal Change
Standard Deviation 0.337887
|
|
BOLD Activation to Smoking Cues - Amygdala
Smoking Personal Environments
|
0.009450 Percent Signal Change
Standard Deviation 0.384823
|
0.090345 Percent Signal Change
Standard Deviation 0.293101
|
|
BOLD Activation to Smoking Cues - Amygdala
Non-Smoking Standard Environments
|
0.044903 Percent Signal Change
Standard Deviation 0.352711
|
0.042836 Percent Signal Change
Standard Deviation 0.341324
|
|
BOLD Activation to Smoking Cues - Amygdala
Smoking Standard Environments
|
0.111746 Percent Signal Change
Standard Deviation 0.321235
|
0.161114 Percent Signal Change
Standard Deviation 0.355927
|
|
BOLD Activation to Smoking Cues - Amygdala
Non-Smoking Proximal
|
0.066409 Percent Signal Change
Standard Deviation 0.386921
|
0.015171 Percent Signal Change
Standard Deviation 0.353829
|
|
BOLD Activation to Smoking Cues - Amygdala
Smoking Proximal
|
0.025432 Percent Signal Change
Standard Deviation 0.378728
|
0.133363 Percent Signal Change
Standard Deviation 0.409809
|
PRIMARY outcome
Timeframe: MRI Scan: 2-3 hours post-administrationPopulation: Participants who completed the study. Excludes two additional participants in the placebo condition who had excessive motion artifact during scanning and could not be included in neuroimaging analyses.
BOLD activation in Anterior Insula (% Signal Change). These are analyzed as separate units for each Trial Type (6 total: Proximal Non-Smoking, Proximal Smoking, Standard Environment Non-Smoking, Standard Environment Smoking, Personal Environment Non-Smoking, personal Environment Smoking), MRI Run (4 total: The task was divided into 4 runs to allow for participant breaks) and Brain Hemisphere (2 total: Left and Right). These are only presented by trial type as MRI Run and Brain Hemisphere are not variables of interest.
Outcome measures
| Measure |
Propranolol
n=176 Trial Type, MRI Run, Brain Hemisphere
Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions
Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
|
Placebo
n=144 Trial Type, MRI Run, Brain Hemisphere
Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions
Placebo: Participants will take one dose of Placebo on two separate occasions.
|
|---|---|---|
|
BOLD Activation to Smoking Cues - Anterior Insula
Non-Smoking Personal Environments
|
-0.179076 Percent Signal Change
Standard Deviation 0.288539
|
-0.157851 Percent Signal Change
Standard Deviation 0.281748
|
|
BOLD Activation to Smoking Cues - Anterior Insula
Smoking Personal Environments
|
-0.127730 Percent Signal Change
Standard Deviation 0.293581
|
-0.142636 Percent Signal Change
Standard Deviation 0.269551
|
|
BOLD Activation to Smoking Cues - Anterior Insula
Non-Smoking Standard Environments
|
-0.118271 Percent Signal Change
Standard Deviation 0.317144
|
-0.152299 Percent Signal Change
Standard Deviation 0.326875
|
|
BOLD Activation to Smoking Cues - Anterior Insula
Smoking Standard Environments
|
-0.146114 Percent Signal Change
Standard Deviation 0.312662
|
-0.149887 Percent Signal Change
Standard Deviation 0.282468
|
|
BOLD Activation to Smoking Cues - Anterior Insula
Non-Smoking Proximal
|
-0.085715 Percent Signal Change
Standard Deviation 0.331652
|
-0.085873 Percent Signal Change
Standard Deviation 0.270967
|
|
BOLD Activation to Smoking Cues - Anterior Insula
Smoking Proximal
|
-0.086867 Percent Signal Change
Standard Deviation 0.352310
|
-0.098181 Percent Signal Change
Standard Deviation 0.318646
|
PRIMARY outcome
Timeframe: MRI Scan: 2-3 hours post-administrationPopulation: Participants who completed the study. Excludes two additional participants in the placebo condition who had excessive motion artifact during scanning and could not be included in neuroimaging analyses.
BOLD activation in Anterior Hippocampus (% Signal Change). These are analyzed as separate units for each Trial Type (6 total: Proximal Non-Smoking, Proximal Smoking, Standard Environment Non-Smoking, Standard Environment Smoking, Personal Environment Non-Smoking, personal Environment Smoking), MRI Run (4 total: The task was divided into 4 runs to allow for participant breaks) and Brain Hemisphere (2 total: Left and Right). These are only presented by trial type as MRI Run and Brain Hemisphere are not variables of interest.
Outcome measures
| Measure |
Propranolol
n=176 Trial Type, MRI Run, Brain Hemisphere
Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions
Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
|
Placebo
n=144 Trial Type, MRI Run, Brain Hemisphere
Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions
Placebo: Participants will take one dose of Placebo on two separate occasions.
|
|---|---|---|
|
BOLD Activation to Smoking Cues - Anterior Hippocampus
Non-Smoking Personal Environments
|
0.061001 Percent Signal Change
Standard Deviation 0.324934
|
0.095120 Percent Signal Change
Standard Deviation 0.271027
|
|
BOLD Activation to Smoking Cues - Anterior Hippocampus
Smoking Personal Environments
|
0.073925 Percent Signal Change
Standard Deviation 0.300800
|
0.088399 Percent Signal Change
Standard Deviation 0.267232
|
|
BOLD Activation to Smoking Cues - Anterior Hippocampus
Non-Smoking Standard Environments
|
0.133369 Percent Signal Change
Standard Deviation 0.315323
|
0.083638 Percent Signal Change
Standard Deviation 0.277520
|
|
BOLD Activation to Smoking Cues - Anterior Hippocampus
Smoking Standard Environments
|
0.171673 Percent Signal Change
Standard Deviation 0.289132
|
0.186590 Percent Signal Change
Standard Deviation 0.300916
|
|
BOLD Activation to Smoking Cues - Anterior Hippocampus
Non-Smoking Proximal
|
0.088852 Percent Signal Change
Standard Deviation 0.323655
|
0.000827 Percent Signal Change
Standard Deviation 0.280219
|
|
BOLD Activation to Smoking Cues - Anterior Hippocampus
Smoking Proximal
|
0.024626 Percent Signal Change
Standard Deviation 0.296327
|
0.095598 Percent Signal Change
Standard Deviation 0.291577
|
PRIMARY outcome
Timeframe: MRI Scan: 2-3 hours post-administrationPopulation: Participants who completed the study. Excludes two additional participants in the placebo condition who had excessive motion artifact during scanning and could not be included in neuroimaging analyses.
BOLD activation in Posterior Hippocampus (% Signal Change). These are analyzed as separate units for each Trial Type (6 total: Proximal Non-Smoking, Proximal Smoking, Standard Environment Non-Smoking, Standard Environment Smoking, Personal Environment Non-Smoking, personal Environment Smoking), MRI Run (4 total: The task was divided into 4 runs to allow for participant breaks) and Brain Hemisphere (2 total: Left and Right). These are only presented by trial type as MRI Run and Brain Hemisphere are not variables of interest.
Outcome measures
| Measure |
Propranolol
n=176 Trial Type, MRI Run, Brain Hemisphere
Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions
Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
|
Placebo
n=144 Trial Type, MRI Run, Brain Hemisphere
Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions
Placebo: Participants will take one dose of Placebo on two separate occasions.
|
|---|---|---|
|
BOLD Activation to Smoking Cues - Posterior Hippocampus
Non-Smoking Personal Environments
|
0.161077 Percent Signal Change
Standard Deviation 0.288481
|
0.185521 Percent Signal Change
Standard Deviation 0.262021
|
|
BOLD Activation to Smoking Cues - Posterior Hippocampus
Smoking Personal Environments
|
0.156684 Percent Signal Change
Standard Deviation 0.303924
|
0.166154 Percent Signal Change
Standard Deviation 0.252282
|
|
BOLD Activation to Smoking Cues - Posterior Hippocampus
Non-Smoking Standard Environments
|
0.137124 Percent Signal Change
Standard Deviation 0.304769
|
0.161655 Percent Signal Change
Standard Deviation 0.241679
|
|
BOLD Activation to Smoking Cues - Posterior Hippocampus
Smoking Standard Environments
|
0.179651 Percent Signal Change
Standard Deviation 0.256910
|
0.176196 Percent Signal Change
Standard Deviation 0.269538
|
|
BOLD Activation to Smoking Cues - Posterior Hippocampus
Non-Smoking Proximal
|
0.056247 Percent Signal Change
Standard Deviation 0.281092
|
0.053026 Percent Signal Change
Standard Deviation 0.271871
|
|
BOLD Activation to Smoking Cues - Posterior Hippocampus
Smoking Proximal
|
0.050077 Percent Signal Change
Standard Deviation 0.260461
|
0.121240 Percent Signal Change
Standard Deviation 0.262651
|
PRIMARY outcome
Timeframe: MRI Scan: 2-3 hours post-administrationPopulation: Participants who completed the study. Excludes two additional participants in the placebo condition who had excessive motion artifact during scanning and could not be included in neuroimaging analyses.
BOLD activation in Medial Prefrontal Cortex (% Signal Change). These are analyzed as separate units for each Trial Type (6 total: Proximal Non-Smoking, Proximal Smoking, Standard Environment Non-Smoking, Standard Environment Smoking, Personal Environment Non-Smoking, personal Environment Smoking), MRI Run (4 total: The task was divided into 4 runs to allow for participant breaks) and Brain Hemisphere (2 total: Left and Right). These are only presented by trial type as MRI Run and Brain Hemisphere are not variables of interest.
Outcome measures
| Measure |
Propranolol
n=176 Trial Type, MRI Run, Brain Hemisphere
Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions
Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
|
Placebo
n=144 Trial Type, MRI Run, Brain Hemisphere
Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions
Placebo: Participants will take one dose of Placebo on two separate occasions.
|
|---|---|---|
|
BOLD Activation to Smoking Cues - Medial Prefrontal Cortex
Non-Smoking Personal Environments
|
0.033030 Percent Signal Change
Standard Deviation 0.322540
|
0.012705 Percent Signal Change
Standard Deviation 0.409304
|
|
BOLD Activation to Smoking Cues - Medial Prefrontal Cortex
Smoking Personal Environments
|
0.058184 Percent Signal Change
Standard Deviation 0.378236
|
0.060320 Percent Signal Change
Standard Deviation 0.313844
|
|
BOLD Activation to Smoking Cues - Medial Prefrontal Cortex
Non-Smoking Standard Environments
|
-0.078483 Percent Signal Change
Standard Deviation 0.350182
|
-0.167025 Percent Signal Change
Standard Deviation 0.447513
|
|
BOLD Activation to Smoking Cues - Medial Prefrontal Cortex
Smoking Standard Environments
|
-0.068693 Percent Signal Change
Standard Deviation 0.311347
|
-0.093598 Percent Signal Change
Standard Deviation 0.447743
|
|
BOLD Activation to Smoking Cues - Medial Prefrontal Cortex
Non-Smoking Proximal
|
-0.039529 Percent Signal Change
Standard Deviation 0.362686
|
-0.109172 Percent Signal Change
Standard Deviation 0.422732
|
|
BOLD Activation to Smoking Cues - Medial Prefrontal Cortex
Smoking Proximal
|
-0.064034 Percent Signal Change
Standard Deviation 0.345958
|
0.015524 Percent Signal Change
Standard Deviation 0.413311
|
PRIMARY outcome
Timeframe: MRI Scan: 2-3 hours post-administrationPopulation: Participants who completed the study. Excludes two additional participants in the placebo condition who had excessive motion artifact during scanning and could not be included in neuroimaging analyses.
Connectivity with right amygdala when viewing proximal smoking images, using a right anterior hippocampus seed region (psychophysiological interaction analysis; PPI). Larger values represent greater connectivity between these regions while viewing proximal smoking images.
Outcome measures
| Measure |
Propranolol
n=22 Participants
Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions
Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
|
Placebo
n=18 Participants
Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions
Placebo: Participants will take one dose of Placebo on two separate occasions.
|
|---|---|---|
|
fMRI BOLD Connectivity
|
-0.0740 PPI Index
Standard Deviation 0.0769
|
0.0228 PPI Index
Standard Deviation 0.0997
|
PRIMARY outcome
Timeframe: MRI Scan: 2-3 hours post-administrationPopulation: Participants who completed the study. Excludes two additional participants in the placebo condition who had excessive motion artifact during scanning and could not be included in neuroimaging analyses.
During MRI Scans, participants rated their craving in response to the question "While focusing on the place/object, I craved a cigarette." using a 1 (Do not agree) to 8 (Strongly agree) scale immediately following each image. Ratings were then averaged within each image category (total scale range of 1-8). Higher values represent greater craving.
Outcome measures
| Measure |
Propranolol
n=22 Participants
Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions
Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
|
Placebo
n=18 Participants
Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions
Placebo: Participants will take one dose of Placebo on two separate occasions.
|
|---|---|---|
|
Cue-Provoked Craving - Proximal Cues
Non-Smoking
|
2.866883 units on a scale
Standard Deviation 1.566946
|
1.898148 units on a scale
Standard Deviation 0.824614
|
|
Cue-Provoked Craving - Proximal Cues
Smoking
|
6.103084 units on a scale
Standard Deviation 1.618450
|
6.547619 units on a scale
Standard Deviation 1.685597
|
PRIMARY outcome
Timeframe: MRI Scan: 2-3 hours post-administrationPopulation: Participants who completed the study. Excludes two additional participants in the placebo condition who had excessive motion artifact during scanning and could not be included in neuroimaging analyses.
During MRI Scans, participants rated their craving in response to the question "While focusing on the place/object, I craved a cigarette." using a 1 (Do not agree) to 8 (Strongly agree) scale immediately following each image. Ratings were then averaged within each image category (total scale range of 1-8). Higher values represent greater craving.
Outcome measures
| Measure |
Propranolol
n=22 Participants
Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions
Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
|
Placebo
n=18 Participants
Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions
Placebo: Participants will take one dose of Placebo on two separate occasions.
|
|---|---|---|
|
Cue-Provoked Craving - Standard Environment Images
Non-Smoking
|
2.673052 units on a scale
Standard Deviation 1.681618
|
1.763889 units on a scale
Standard Deviation 0.644389
|
|
Cue-Provoked Craving - Standard Environment Images
Smoking
|
4.666937 units on a scale
Standard Deviation 1.588874
|
4.868056 units on a scale
Standard Deviation 1.716846
|
PRIMARY outcome
Timeframe: MRI Scan: 2-3 hours post-administrationPopulation: Participants who completed the study. Excludes two additional participants in the placebo condition who had excessive motion artifact during scanning and could not be included in neuroimaging analyses.
During MRI Scans, participants rated their craving in response to the question "While focusing on the place/object, I craved a cigarette." using a 1 (Do not agree) to 8 (Strongly agree) scale immediately following each image. Ratings were then averaged within each image category (total scale range of 1-8). Higher values represent greater craving.
Outcome measures
| Measure |
Propranolol
n=22 Participants
Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions
Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
|
Placebo
n=20 Participants
Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions
Placebo: Participants will take one dose of Placebo on two separate occasions.
|
|---|---|---|
|
Cue-Provoked Craving - Personal Environment Cues
Non-Smoking
|
3.369318 units on a scale
Standard Deviation 1.802147
|
2.965278 units on a scale
Standard Deviation 1.668703
|
|
Cue-Provoked Craving - Personal Environment Cues
Smoking
|
6.045996 units on a scale
Standard Deviation 1.457661
|
6.638889 units on a scale
Standard Deviation 1.569405
|
SECONDARY outcome
Timeframe: Lab Task: 2-3 hours post-administrationPopulation: Participants who completed the study.
Self-reported craving to smoke following presentation of personal smoking environments (prior to ad-lib smoking period). Assessed using the average rating across four questions drawn from the Questionnaire on Smoking Urges: (1) While focusing on those places...nothing would have been better than smoking a cigarette; (2) While focusing on those places...I had the urge for a cigarette; (3) While focusing on those places...all I wanted right then was a cigarette; (4) While focusing on those places...I craved a cigarette. Participants rated each item on an 11-point scale ranging from 0 (Do not agree) to 100 (Strongly agree) in 10-point intervals. These ratings were averaged across items for analysis. higher values represent greater craving. Tiffany, S. T., \& Drobes, D. J. (1991). The development and initial validation of a questionnaire on smoking urges. British Journal of addiction, 86(11), 1467-1476.
Outcome measures
| Measure |
Propranolol
n=22 Participants
Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions
Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
|
Placebo
n=20 Participants
Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions
Placebo: Participants will take one dose of Placebo on two separate occasions.
|
|---|---|---|
|
Laboratory Visit - Self-Reported Craving
|
7.3 units on a scale
Standard Deviation 2.7
|
7.9 units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Lab Task: 2-3 hours post-administrationPopulation: Participants who completed the study. Data from one participant in the placebo condition was lost due to technical problems with the recording.
Number of cigarette puffs taken during ad lib smoking period while participants view images of their personal smoking environment. Smoking was video recorded and puffs were coded by two raters.
Outcome measures
| Measure |
Propranolol
n=22 Participants
Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions
Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
|
Placebo
n=19 Participants
Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions
Placebo: Participants will take one dose of Placebo on two separate occasions.
|
|---|---|---|
|
Laboratory Visit - # Cigarette Puffs
|
15.2 Puffs
Standard Deviation 7.1
|
17.7 Puffs
Standard Deviation 9.8
|
Adverse Events
Propranolol
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Propranolol
n=22 participants at risk
Propranolol Capsule: 40 mg IR, administered 2x at separate laboratory sessions
Propranolol: Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
|
Placebo
n=22 participants at risk
Placebo Capsule: No active ingredients, administered 2x at separate laboratory sessions
Placebo: Participants will take one dose of Placebo on two separate occasions.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dog Bite
|
4.5%
1/22 • Number of events 1 • This is an acute administration study with an approved medication with a well-established safety profile. Adverse events were assessed over the 1-3 month period in which participants were engaged in the project, primarily for purposes of ensuring new contraindications did not emerge prior to drug administration vs concerns about adverse events related to the drug itself.
Participants abstain from smoking for 24 hours before the MRI visit and 6 hours before the laboratory visit. Symptoms of nicotine withdrawal are assessed but are not considered adverse events. Participant self-report of any newly-onset or worsening medical problems during their time of participation are considered adverse events. Repeat blood draws were occasionally necessary but are also not considered adverse events.
|
0.00%
0/22 • This is an acute administration study with an approved medication with a well-established safety profile. Adverse events were assessed over the 1-3 month period in which participants were engaged in the project, primarily for purposes of ensuring new contraindications did not emerge prior to drug administration vs concerns about adverse events related to the drug itself.
Participants abstain from smoking for 24 hours before the MRI visit and 6 hours before the laboratory visit. Symptoms of nicotine withdrawal are assessed but are not considered adverse events. Participant self-report of any newly-onset or worsening medical problems during their time of participation are considered adverse events. Repeat blood draws were occasionally necessary but are also not considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Wrist Injury
|
0.00%
0/22 • This is an acute administration study with an approved medication with a well-established safety profile. Adverse events were assessed over the 1-3 month period in which participants were engaged in the project, primarily for purposes of ensuring new contraindications did not emerge prior to drug administration vs concerns about adverse events related to the drug itself.
Participants abstain from smoking for 24 hours before the MRI visit and 6 hours before the laboratory visit. Symptoms of nicotine withdrawal are assessed but are not considered adverse events. Participant self-report of any newly-onset or worsening medical problems during their time of participation are considered adverse events. Repeat blood draws were occasionally necessary but are also not considered adverse events.
|
4.5%
1/22 • Number of events 1 • This is an acute administration study with an approved medication with a well-established safety profile. Adverse events were assessed over the 1-3 month period in which participants were engaged in the project, primarily for purposes of ensuring new contraindications did not emerge prior to drug administration vs concerns about adverse events related to the drug itself.
Participants abstain from smoking for 24 hours before the MRI visit and 6 hours before the laboratory visit. Symptoms of nicotine withdrawal are assessed but are not considered adverse events. Participant self-report of any newly-onset or worsening medical problems during their time of participation are considered adverse events. Repeat blood draws were occasionally necessary but are also not considered adverse events.
|
Additional Information
Jason A. Oliver, Ph.D.
Duke University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place