Trial Outcomes & Findings for Enhancing Self Regulation Among Smokers (NCT NCT04161144)
NCT ID: NCT04161144
Last Updated: 2021-03-09
Results Overview
Patients are asked about craving level on a scale of 0-100, 0 is least amount of craving and 100 is highest amount of craving
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Study visit 1 (Baseline; day 0), visit 2 (day 7) and visit 3 (day 14)
Results posted on
2021-03-09
Participant Flow
Participant milestones
| Measure |
Rapamycin 15mg (Sirolimus)
Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.
sirolimus: Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.
|
Placebo
Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.
Placebo: Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Rapamycin 15mg (Sirolimus)
Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.
sirolimus: Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.
|
Placebo
Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.
Placebo: Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Enhancing Self Regulation Among Smokers
Baseline characteristics by cohort
| Measure |
Rapamycin 15mg (Sirolimus)
n=12 Participants
Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.
sirolimus: Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.
|
Placebo
n=10 Participants
Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.
Placebo: Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 15.2 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 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
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Cigarettes Per Day
|
21.5 Cigarettes Per Day
STANDARD_DEVIATION 9.5 • n=5 Participants
|
19.7 Cigarettes Per Day
STANDARD_DEVIATION 10.3 • n=7 Participants
|
20.7 Cigarettes Per Day
STANDARD_DEVIATION 9.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Study visit 1 (Baseline; day 0), visit 2 (day 7) and visit 3 (day 14)Population: Data entered are the number of participants under the cue condition at study visit 1 (Baseline; day 0), visit 2 (day 7) and visit 3 (day 14)
Patients are asked about craving level on a scale of 0-100, 0 is least amount of craving and 100 is highest amount of craving
Outcome measures
| Measure |
Rapamycin 15mg (Sirolimus)
n=12 Participants
Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.
sirolimus: Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.
|
Placebo
n=9 Participants
Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.
Placebo: Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.
|
|---|---|---|
|
Craving Levels in Response to Cue
Day 0: Pre-Cue
|
69.6 score on a scale
Standard Deviation 26.3
|
66.3 score on a scale
Standard Deviation 27.8
|
|
Craving Levels in Response to Cue
Day 0: Cue
|
56.1 score on a scale
Standard Deviation 35.2
|
74.4 score on a scale
Standard Deviation 16.1
|
|
Craving Levels in Response to Cue
Day 0: Cue+0 min
|
62.6 score on a scale
Standard Deviation 34.4
|
83.2 score on a scale
Standard Deviation 18.1
|
|
Craving Levels in Response to Cue
Day 0: Cue+10 min
|
53.1 score on a scale
Standard Deviation 33.4
|
72.8 score on a scale
Standard Deviation 16.8
|
|
Craving Levels in Response to Cue
Day 0: Cue+20 min
|
50.4 score on a scale
Standard Deviation 37.7
|
71.7 score on a scale
Standard Deviation 23.5
|
|
Craving Levels in Response to Cue
Day 0: Cue+30 min
|
44.3 score on a scale
Standard Deviation 37.7
|
67.8 score on a scale
Standard Deviation 25.9
|
|
Craving Levels in Response to Cue
Day 0: Cue+40 min
|
39.1 score on a scale
Standard Deviation 39.7
|
67.2 score on a scale
Standard Deviation 27.6
|
|
Craving Levels in Response to Cue
Day 0: Cue+50 min
|
38.1 score on a scale
Standard Deviation 37.7
|
63.7 score on a scale
Standard Deviation 32.1
|
|
Craving Levels in Response to Cue
Day 7: Pre-Cue
|
40.9 score on a scale
Standard Deviation 37.6
|
62.2 score on a scale
Standard Deviation 27.7
|
|
Craving Levels in Response to Cue
Day 7: Cue
|
41.9 score on a scale
Standard Deviation 38.1
|
67.2 score on a scale
Standard Deviation 29.3
|
|
Craving Levels in Response to Cue
Day 7: Cue+0 min
|
46.8 score on a scale
Standard Deviation 36.1
|
68.3 score on a scale
Standard Deviation 28.7
|
|
Craving Levels in Response to Cue
Day 7: Cue+10 min
|
43.1 score on a scale
Standard Deviation 37.2
|
59.4 score on a scale
Standard Deviation 27.4
|
|
Craving Levels in Response to Cue
Day 7: Cue+20 min
|
43.4 score on a scale
Standard Deviation 37.9
|
55.5 score on a scale
Standard Deviation 29.6
|
|
Craving Levels in Response to Cue
Day 7: Cue+30 min
|
40.4 score on a scale
Standard Deviation 40.0
|
52.8 score on a scale
Standard Deviation 30.7
|
|
Craving Levels in Response to Cue
Day 7: Cue+40 min
|
39.8 score on a scale
Standard Deviation 40.5
|
52.2 score on a scale
Standard Deviation 31.0
|
|
Craving Levels in Response to Cue
Day 7: Cue+50 min
|
39.7 score on a scale
Standard Deviation 40.6
|
49.4 score on a scale
Standard Deviation 33.2
|
|
Craving Levels in Response to Cue
Day 14: Pre-Cue
|
37.3 score on a scale
Standard Deviation 36.8
|
41.7 score on a scale
Standard Deviation 31.1
|
|
Craving Levels in Response to Cue
Day 14: Cue
|
45 score on a scale
Standard Deviation 34.5
|
46.7 score on a scale
Standard Deviation 32.3
|
|
Craving Levels in Response to Cue
Day 14: Cue+0 min
|
44.3 score on a scale
Standard Deviation 34.5
|
48.9 score on a scale
Standard Deviation 32.1
|
|
Craving Levels in Response to Cue
Day 14: Cue+10 min
|
43.6 score on a scale
Standard Deviation 32.4
|
45.6 score on a scale
Standard Deviation 29.5
|
|
Craving Levels in Response to Cue
Visit 3: Cue+20 min
|
40.3 score on a scale
Standard Deviation 32.1
|
40 score on a scale
Standard Deviation 28.6
|
|
Craving Levels in Response to Cue
Day 14: Cue+30 min
|
39.5 score on a scale
Standard Deviation 32.7
|
43.3 score on a scale
Standard Deviation 31.2
|
|
Craving Levels in Response to Cue
Day 14: Cue+40 min
|
40.5 score on a scale
Standard Deviation 32.3
|
38.9 score on a scale
Standard Deviation 30.7
|
|
Craving Levels in Response to Cue
Day 14: Cue+50 min
|
41.2 score on a scale
Standard Deviation 33.1
|
37.2 score on a scale
Standard Deviation 30.1
|
PRIMARY outcome
Timeframe: Study visit 1 (Baseline; day 0), visit 2 (day 7) and visit 3 (day 14)Population: Data entered are the number of participants under the cue condition at study visit 1 (Baseline; day 0), visit 2 (day 7) and visit 3 (day 14)
Heart rate is measured using a Biopac machine and Acqknowledge software at different timepoints throughout each visit while the participants are exposed to smoking cues.
Outcome measures
| Measure |
Rapamycin 15mg (Sirolimus)
n=12 Participants
Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.
sirolimus: Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.
|
Placebo
n=10 Participants
Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.
Placebo: Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.
|
|---|---|---|
|
Heart Rate in Response to Cue
Day 0: Pre-Cue
|
72 Beats per minute
Standard Deviation 9
|
75 Beats per minute
Standard Deviation 16
|
|
Heart Rate in Response to Cue
Day 0: Cue+0 min
|
71 Beats per minute
Standard Deviation 11
|
73 Beats per minute
Standard Deviation 13
|
|
Heart Rate in Response to Cue
Day 0: Cue+10 min
|
69 Beats per minute
Standard Deviation 12
|
70 Beats per minute
Standard Deviation 14
|
|
Heart Rate in Response to Cue
Day 0: Cue+20 min
|
69 Beats per minute
Standard Deviation 11
|
69 Beats per minute
Standard Deviation 15
|
|
Heart Rate in Response to Cue
Day 0: Cue+30 min
|
70 Beats per minute
Standard Deviation 13
|
72 Beats per minute
Standard Deviation 12
|
|
Heart Rate in Response to Cue
Day 0: Cue+40 min
|
71 Beats per minute
Standard Deviation 11
|
68 Beats per minute
Standard Deviation 12
|
|
Heart Rate in Response to Cue
Day 0: Cue+50 min
|
72 Beats per minute
Standard Deviation 11
|
70 Beats per minute
Standard Deviation 11
|
|
Heart Rate in Response to Cue
Day 7: Pre-Cue
|
73 Beats per minute
Standard Deviation 9
|
75 Beats per minute
Standard Deviation 11
|
|
Heart Rate in Response to Cue
Day 7: Cue+0 min
|
71 Beats per minute
Standard Deviation 11
|
74 Beats per minute
Standard Deviation 11
|
|
Heart Rate in Response to Cue
Day 7: Cue+10 min
|
69 Beats per minute
Standard Deviation 11
|
75 Beats per minute
Standard Deviation 9
|
|
Heart Rate in Response to Cue
Day 7: Cue+20 min
|
71 Beats per minute
Standard Deviation 10
|
74 Beats per minute
Standard Deviation 12
|
|
Heart Rate in Response to Cue
Day 7: Cue+30 min
|
71 Beats per minute
Standard Deviation 12
|
74 Beats per minute
Standard Deviation 14
|
|
Heart Rate in Response to Cue
Day 7: Cue+40 min
|
71 Beats per minute
Standard Deviation 13
|
71 Beats per minute
Standard Deviation 12
|
|
Heart Rate in Response to Cue
Day 7: Cue+50 min
|
70 Beats per minute
Standard Deviation 12
|
72 Beats per minute
Standard Deviation 14
|
|
Heart Rate in Response to Cue
Day 14: Pre-Cue
|
75 Beats per minute
Standard Deviation 7
|
73 Beats per minute
Standard Deviation 14
|
|
Heart Rate in Response to Cue
Day 14: Cue+0 min
|
70 Beats per minute
Standard Deviation 15
|
73 Beats per minute
Standard Deviation 17
|
|
Heart Rate in Response to Cue
Day 14: Cue+10 min
|
70 Beats per minute
Standard Deviation 15
|
66 Beats per minute
Standard Deviation 14
|
|
Heart Rate in Response to Cue
Day 14: Cue+20 min
|
71 Beats per minute
Standard Deviation 11
|
66 Beats per minute
Standard Deviation 14
|
|
Heart Rate in Response to Cue
Day 14: Cue+30 min
|
73 Beats per minute
Standard Deviation 9
|
68 Beats per minute
Standard Deviation 15
|
|
Heart Rate in Response to Cue
Day 14: Cue+40 min
|
72 Beats per minute
Standard Deviation 13
|
68 Beats per minute
Standard Deviation 16
|
|
Heart Rate in Response to Cue
Day 14: Cue+50 min
|
72 Beats per minute
Standard Deviation 10
|
70 Beats per minute
Standard Deviation 16
|
SECONDARY outcome
Timeframe: Visit 1 through Visit 3 (day 0-day 14)Population: Self-reported average cigarettes smoked per day reported between study visit 1 and visit 3
Patients will be asked how many cigarettes per day they smoked 90 days prior to starting the study. Patients are then given a smoking and alcohol diary to complete during the course of the trial.
Outcome measures
| Measure |
Rapamycin 15mg (Sirolimus)
n=11 Participants
Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.
sirolimus: Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.
|
Placebo
n=9 Participants
Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.
Placebo: Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.
|
|---|---|---|
|
Average Cigarettes Smoked Per Day
|
7.6 Cigarettes Per Day
Standard Deviation 6.2
|
13.5 Cigarettes Per Day
Standard Deviation 9.5
|
Adverse Events
Rapamycin 15mg (Sirolimus)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rapamycin 15mg (Sirolimus)
n=12 participants at risk
Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.
sirolimus: Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.
|
Placebo
n=10 participants at risk
Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group.
Placebo: Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.
|
|---|---|---|
|
Nervous system disorders
Headache
|
41.7%
5/12 • Number of events 8 • 14 days
|
20.0%
2/10 • Number of events 2 • 14 days
|
|
General disorders
Dry Mouth
|
8.3%
1/12 • Number of events 3 • 14 days
|
10.0%
1/10 • Number of events 1 • 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
8.3%
1/12 • Number of events 1 • 14 days
|
20.0%
2/10 • Number of events 2 • 14 days
|
|
General disorders
Taste Anomoly
|
8.3%
1/12 • Number of events 2 • 14 days
|
10.0%
1/10 • Number of events 2 • 14 days
|
|
General disorders
Increased Thirst
|
16.7%
2/12 • Number of events 3 • 14 days
|
20.0%
2/10 • Number of events 2 • 14 days
|
|
Psychiatric disorders
Restlessness
|
16.7%
2/12 • Number of events 2 • 14 days
|
10.0%
1/10 • Number of events 1 • 14 days
|
|
General disorders
weakness/Fatigue
|
16.7%
2/12 • Number of events 2 • 14 days
|
0.00%
0/10 • 14 days
|
|
Psychiatric disorders
Nightmares/Vivid Dreams
|
16.7%
2/12 • Number of events 2 • 14 days
|
0.00%
0/10 • 14 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place