Status:
TERMINATED
Neuro Biomarkers of Smoking Behavior
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Smoking Cessation
Eligibility:
All Genders
21-40 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate cognition in smokers and nonsmokers. It involves administration of intranasal insulin (Novolin R), an investigational medication followed by a brief non-invasi...
Detailed Description
This program of research focuses on identifying neurologic biomarkers of smoking behavior in order to develop individualized smoking cessation aids. The intranasal insulin administered is an investiga...
Eligibility Criteria
Inclusion
- Age between 21-40 years
- Smokers only: Begin smoking within 5 minutes of waking (verified by carbon monoxide concentrations greater than 10 ppm).
- Non-smokers only: No self-reported cigarette use in the past 1-year period.
- Non-smokers only: Carbon monoxide concentration \< 6 ppm.
- Normal vitals (blood pressure \< 120/80 mmHg; heart rate between 60 and 100 bpm, body temperature \<37 °C)
- Point-of-care (POC) blood glucose between 80 and 140 mg/dL
- Body mass index between 18.5 and 30 kg/m2
Exclusion
- Use of non-cigarette tobacco products, e-cigarettes, or smoking cessation treatment
- Positive urine drug screen test
- Current pregnancy (urine test-verified) or lactation, or a plan to become pregnant
- Breath Alcohol Concentration \>0.00%
- Shipley IQ (Intelligence Quotient) test \<80
- Hyposmic or anosmic individuals (identifying less than 10 of 12 smells correctly)
- Abnormal physical exam of the nares
- Lifetime DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) Axis 1 disorder (except anxiety and depression)
- Current DSM-5 Axis depression or anxiety disorder
- Prescription medications
- Over-the-counter psychotropic medications
- Use of any medications administered intranasally
- Allergies to any ingredients in intranasal insulin or placebo
- Braided hair that would cause noise in EEG recording
Key Trial Info
Start Date :
September 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03811951
Start Date
September 12 2018
End Date
September 27 2019
Last Update
March 2 2021
Active Locations (1)
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1
University of Illinois Department of Pharmacy Practice
Chicago, Illinois, United States, 60612