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Neuro Biomarkers of Smoking Behavior

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ClinicalTrials.gov Identifier: NCT03811951
Recruitment Status : Terminated (Different study initiation)
First Posted : January 22, 2019
Results First Posted : March 2, 2021
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Ajna Hamidovic, PharmD, MS, University of Illinois at Chicago

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-invasive cognitive test. All participants will receive both Novolin R and placebo in two separate testing sessions.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Novolin R Phase 2

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 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 computerized tasks. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: The University of Illinois Hospital and Health Sciences System Investigational Drug Service (IDS) randomizes treatment order to study subjects and prepares drug product and placebo. All other roles, including participant, investigator, and non-IDS study personnel are masked from treatment order.
Primary Purpose: Diagnostic
Official Title: Neurologic Biomarkers of Smoking Behavior
Actual Study Start Date : September 12, 2018
Actual Primary Completion Date : September 27, 2019
Actual Study Completion Date : September 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: 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.
Drug: 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.
Other Name: McKesson Corporation, Novo Nordisk

Experimental: Non-Smokers
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.
Drug: 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.
Other Name: McKesson Corporation, Novo Nordisk




Primary Outcome Measures :
  1. Go/No-Go Accuracy [ Time Frame: From time of drug administration to 70 minutes following drug administration, up to 90 minutes ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811951


Locations
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United States, Illinois
University of Illinois Department of Pharmacy Practice
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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Principal Investigator: Ajna Hamidovic, PharmD, MS University of Illinois at Chicago
  Study Documents (Full-Text)

Documents provided by Ajna Hamidovic, PharmD, MS, University of Illinois at Chicago:
Informed Consent Form  [PDF] November 8, 2018

Publications:

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Responsible Party: Ajna Hamidovic, PharmD, MS, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03811951    
Other Study ID Numbers: 2017-1288
First Posted: January 22, 2019    Key Record Dates
Results First Posted: March 2, 2021
Last Update Posted: March 2, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ajna Hamidovic, PharmD, MS, University of Illinois at Chicago:
Tobacco
Cigarettes
Nicotine
Insulin
Additional relevant MeSH terms:
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Insulin
Hypoglycemic Agents
Physiological Effects of Drugs