Trial Outcomes & Findings for Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome (NCT NCT01781234)
NCT ID: NCT01781234
Last Updated: 2018-12-10
Results Overview
California Verbal Learning Task Number of Words Learned Higher Values Mean Better Outcome
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
90 minutes
Results posted on
2018-12-10
Participant Flow
Participant milestones
| Measure |
Intranasal Insulin
Group receiving active treatment
|
Placebo
Group receiving placebo
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
24
|
|
Overall Study
COMPLETED
|
18
|
21
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
| Measure |
Intranasal Insulin
Group receiving active treatment
|
Placebo
Group receiving placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
Baseline Characteristics
Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome
Baseline characteristics by cohort
| Measure |
Intranasal Insulin
n=16 Participants
Group receiving active treatment
|
Placebo
n=21 Participants
Group receiving placebo
|
Total
n=37 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
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.75 years
STANDARD_DEVIATION 13.23 • n=5 Participants
|
40.19 years
STANDARD_DEVIATION 13.74 • n=7 Participants
|
37.34694 years
STANDARD_DEVIATION 12.45417 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 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
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
21 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 minutesCalifornia Verbal Learning Task Number of Words Learned Higher Values Mean Better Outcome
Outcome measures
| Measure |
Intranasal Insulin
n=16 Participants
Intranasal Insulin
Intranasal Insulin
|
Placebo
n=21 Participants
Placebo
Placebo
|
|---|---|---|
|
Episodic Memory
|
11.6 number of words recalled
Standard Error 0.3
|
10.0 number of words recalled
Standard Error 0.3
|
PRIMARY outcome
Timeframe: 90 minutesOutcome measures
| Measure |
Intranasal Insulin
n=16 Participants
Intranasal Insulin
Intranasal Insulin
|
Placebo
n=21 Participants
Placebo
Placebo
|
|---|---|---|
|
Salivary Cortisol
|
0.23 mcg/dL
Standard Error 0.02
|
0.13 mcg/dL
Standard Error 0.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 minutesQuestionnaire of Smoking Urges; Total Range= 10-70; Higher values represent worse outcome
Outcome measures
| Measure |
Intranasal Insulin
n=16 Participants
Intranasal Insulin
Intranasal Insulin
|
Placebo
n=21 Participants
Placebo
Placebo
|
|---|---|---|
|
Nicotine Craving (Measured by Questionnaire of Smoking Urges)
|
30.48 units on a scale
Standard Error 1.42
|
43.44 units on a scale
Standard Error 1.39
|
Adverse Events
Intranasal Insulin
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intranasal Insulin
n=27 participants at risk
Group receiving active treatment
|
Placebo
n=24 participants at risk
Group receiving placebo
|
|---|---|---|
|
General disorders
Rhinorrhea
|
7.4%
2/27 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Smell
|
29.6%
8/27 • Number of events 10
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Tingling
|
14.8%
4/27 • Number of events 5
|
0.00%
0/24
|
|
General disorders
Irritation
|
25.9%
7/27 • Number of events 9
|
0.00%
0/24
|
|
General disorders
Sneezing
|
7.4%
2/27 • Number of events 2
|
0.00%
0/24
|
|
General disorders
Numbness
|
11.1%
3/27 • Number of events 5
|
0.00%
0/24
|
|
General disorders
Burning
|
7.4%
2/27 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Sensitivity
|
3.7%
1/27 • Number of events 2
|
0.00%
0/24
|
|
General disorders
Pressure
|
0.00%
0/27
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Congestion
|
3.7%
1/27 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Bleeding
|
3.7%
1/27 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Dryness
|
3.7%
1/27 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Pressure (ears)
|
0.00%
0/27
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Pressure (eye)
|
0.00%
0/27
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Dizziness
|
22.2%
6/27 • Number of events 7
|
0.00%
0/24
|
|
General disorders
Taste
|
0.00%
0/27
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Sweating
|
14.8%
4/27 • Number of events 4
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Bruising
|
0.00%
0/27
|
4.2%
1/24 • Number of events 2
|
|
General disorders
Headache
|
7.4%
2/27 • Number of events 2
|
0.00%
0/24
|
|
General disorders
Stomach Pain
|
3.7%
1/27 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Blurry Vision
|
0.00%
0/27
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Tingling (throat)
|
0.00%
0/27
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Confusion
|
25.9%
7/27 • Number of events 7
|
8.3%
2/24 • Number of events 2
|
|
General disorders
Numbness (arm)
|
3.7%
1/27 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Tingling (mouth)
|
0.00%
0/27
|
12.5%
3/24 • Number of events 3
|
|
General disorders
Cold
|
0.00%
0/27
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Shaking
|
7.4%
2/27 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Anxiety
|
0.00%
0/27
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Itchiness
|
3.7%
1/27 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Diarrhea
|
3.7%
1/27 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Difficulty Breathing
|
3.7%
1/27 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/27
|
4.2%
1/24 • Number of events 1
|
Additional Information
Dr. Ajna Hamidovic
University of Illinois College of Pharmacy
Phone: 312-355-1713
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place