Trial Outcomes & Findings for Neuro Biomarkers of Smoking Behavior (NCT NCT03811951)

NCT ID: NCT03811951

Last Updated: 2021-03-02

Results Overview

Go/No-Go is used to measure a participants capacity for sustained attention and response control. The test requires a participant to perform an action given certain stimuli (e.g., press a button - Go) and inhibit that action under a different set of stimuli (e.g., not press that same button - No-Go). Average of the 2 runs (run 1 - insulin; run 2 - placebo) were calculated for mean reaction time (+SEM) of smokers and non-smokers on no-go stimuli. The minimum reaction time was 23.08 ms and the maximum reaction time was 97.44 ms. The higher mean value represents slower the reaction time, and the lower mean value represents quicker the reaction time. The higher value means that participants have difficulties with inhibiting a prepotent response. The values do not represent a better or worse outcome.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

From time of drug administration to 70 minutes following drug administration, up to 90 minutes

Results posted on

2021-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	Novolin R First, Then Placebo Participants received active ingredients of intranasal insulin, Novolin R, every 3 minutes for the total of 6 sprays in session 1. Then, participants received placebo intranasal spray every 3 minutes for the total of 6 sprays in session 2.	Placebo First, Then Novolin R Participants received placebo intranasal spray every 3 minutes for the total of 6 sprays in session 1. Then, participants received active ingredients of intranasal insulin, Novolin R, every 3 minutes for the total of 6 sprays in session 2.
First Intervention (1 Day) STARTED	2	2
First Intervention (1 Day) COMPLETED	2	2
First Intervention (1 Day) NOT COMPLETED	0	0
Washout (1 Week) STARTED	2	2
Washout (1 Week) COMPLETED	2	2
Washout (1 Week) NOT COMPLETED	0	0
Second Intervention (1 Day) STARTED	2	2
Second Intervention (1 Day) COMPLETED	2	2
Second Intervention (1 Day) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neuro Biomarkers of Smoking Behavior

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Novolin R First, Then Placebo n=2 Participants Participants received active ingredients of intranasal insulin, Novolin R, every 3 minutes for the total of 6 sprays in session 1. Then, participants received placebo intranasal spray every 3 minutes for the total of 6 sprays in session 2.	Placebo First, Then Novolin R n=2 Participants Participants received placebo intranasal spray every 3 minutes for the total of 6 sprays in session 1. Then, participants received active ingredients of intranasal insulin, Novolin R, every 3 minutes for the total of 6 sprays in session 2.	Total n=4 Participants Total of all reporting groups
Age, Continuous	24 years n=93 Participants	24.5 years n=4 Participants	24.25 years n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized White	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Asian	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Unknown/do not want to specify	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	2 participants n=93 Participants	2 participants n=4 Participants	4 participants n=27 Participants

PRIMARY outcome

Timeframe: From time of drug administration to 70 minutes following drug administration, up to 90 minutes

Population: All the participants were non-smokers

Outcome measures

Outcome measures
Measure	Smokers All participants receive both Novolin R (experimental drug) and 14% NaCl (Sodium Chloride) solution (placebo), to be administered in randomly assigned order on two separate testing sessions. During administration of either Novolin R or 14% NaCl, participants will receive 1 spray in each nostril every 3 minutes for a total of 6 sprays. The nasal spray bottle delivers 0.1 ml of liquid per spray. Since the concentration of insulin in Novolin R is 100 IU/mL, six sprays will deliver a 60 IU dose. Novolin R: Novolin R is a sterile, clear, aqueous, and colorless solution that contains human insulin (rDNA origin) 100 units/mL, glycerol 16 mg/mL, metacresol 3 mg/mL, zinc chloride approximately 7 mcg/mL and water for injection. The pH (potential Hydrogen) is adjusted to 7.4. Hydrochloric acid 2N (concentration) or sodium hydroxide 2N may be added to adjust pH. Novolin R vials are latex-free. The drug substance is being purchased from McKesson.	Non-Smokers n=4 Participants All participants receive both Novolin R (experimental drug) and 14% NaCl solution (placebo), to be administered in randomly assigned order on two separate testing sessions. During administration of either Novolin R or 14% NaCl, participants will receive 1 spray in each nostril every 3 minutes for a total of 6 sprays. The nasal spray bottle delivers 0.1 ml of liquid per spray. Since the concentration of insulin in Novolin R is 100 IU/mL, six sprays will deliver a 60 IU dose. Novolin R: Novolin R is a sterile, clear, aqueous, and colorless solution that contains human insulin (rDNA origin) 100 units/mL, glycerol 16 mg/mL, metacresol 3 mg/mL, zinc chloride approximately 7 mcg/mL and water for injection. The pH (potential Hydrogen) is adjusted to 7.4. Hydrochloric acid 2N (concentration) or sodium hydroxide 2N may be added to adjust pH. Novolin R vials are latex-free. The drug substance is being purchased from McKesson.
Go/No-Go Accuracy Run 1 (Insulin)	—	70.771 Milliseconds Standard Deviation 25.82
Go/No-Go Accuracy Run 2 (Placebo)	—	67.693 Milliseconds Standard Deviation 27.95

Adverse Events

Novolin R (First Intervention)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo (First Intervention)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo (Second Intervention)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Novolin R (Second Intervention)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Novolin R (First Intervention) n=2 participants at risk Participants received active ingredients of intranasal insulin, Novolin R, every 3 minutes for the total of 6 sprays in first session.	Placebo (First Intervention) n=2 participants at risk Participants received placebo intranasal spray every 3 minutes for the total of 6 sprays in first session.	Placebo (Second Intervention) n=2 participants at risk Participants received placebo intranasal spray every 3 minutes for the total of 6 sprays in second session.	Novolin R (Second Intervention) n=2 participants at risk Participants received active ingredients of intranasal insulin, Novolin R, every 3 minutes for the total of 6 sprays in second session.
General disorders Nasal Irritation	100.0% 2/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	50.0% 1/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	50.0% 1/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	50.0% 1/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed
General disorders Sweating	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	50.0% 1/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed
General disorders Sneezing	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	50.0% 1/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed
General disorders Decreased sense of smell, but not total loss	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	50.0% 1/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed
General disorders Partial anosmia (blunted)	50.0% 1/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed
General disorders Stinginess	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	50.0% 1/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed
General disorders Hunger	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	50.0% 1/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed
General disorders Dizziness	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	50.0% 1/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed
General disorders Sinus Pain	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	50.0% 1/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	0.00% 0/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed
General disorders Pain	100.0% 2/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	100.0% 2/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	100.0% 2/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	100.0% 2/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed
General disorders Burning	100.0% 2/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	100.0% 2/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	100.0% 2/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	100.0% 2/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed
General disorders Taste	100.0% 2/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	100.0% 2/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	100.0% 2/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed	100.0% 2/2 • 2 sessions, up to 2 days All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none observed

Additional Information

Ajna Hamidovic

University of Illinois at Chicago - College of Pharmacy

Phone: 312-355-1713

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place