Neuro Biomarkers of Smoking Behavior
| Status: | Recruiting |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - 40 |
| Updated: | 1/23/2019 |
| Start Date: | September 12, 2018 |
| End Date: | September 12, 2020 |
| Contact: | Ajna Hamidovic, PharmD, MS |
| Email: | ahamidov@uic.edu |
| Phone: | 312-355-1713 |
Neurologic Biomarkers of Smoking Behavior
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-invasive cognitive test, during which brain waves are recorded. All participants
will receive both Novolin R and placebo in two separate testing sessions.
administration of intranasal insulin (Novolin R), an investigational medication followed by a
brief non-invasive cognitive test, during which brain waves are recorded. All participants
will receive both Novolin R and placebo in two separate testing sessions.
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 investigational drug and has been granted IND status by the FDA (IND#129432). During
the times of drug effects, the investigators will evaluate a biomarker using non-invasive
equipment. Non-smokers and smokers will participate in two testing sessions where the
biomarker will be critically evaluated after administration of intranasal insulin and
compared to the cognitive processes elicited by placebo administration.
order to develop individualized smoking cessation aids. The intranasal insulin administered
is an investigational drug and has been granted IND status by the FDA (IND#129432). During
the times of drug effects, the investigators will evaluate a biomarker using non-invasive
equipment. Non-smokers and smokers will participate in two testing sessions where the
biomarker will be critically evaluated after administration of intranasal insulin and
compared to the cognitive processes elicited by placebo administration.
Inclusion Criteria:
- 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 Criteria:
- 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
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