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Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03612960
Recruitment Status : Suspended (Temporarily suspended due to Pandemic)
First Posted : August 2, 2018
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Andrea Hobkirk, PhD, Milton S. Hershey Medical Center

Brief Summary:
The overall goal of this study is to determine if switching to very low nicotine content cigarettes changes the function of brain circuitry involved in incentive salience and executive control among dependent smokers.

Condition or disease Intervention/treatment Phase
Tobacco Dependence Drug: Very low nicotine content cigarettes Drug: Normal nicotine content cigarettes Early Phase 1

Detailed Description:
In a double-blind, randomized controlled trial, dependent smokers will be randomized to a 6-week very low nicotine content (VLNC) cigarette condition (N=50) or a 6-week normal nicotine content cigarette control condition (NNC; N=25). Participants will undergo functional magnetic resonance imaging (fMRI) scans at baseline, 3-weeks, and 6-weeks to investigate the nicotine-related modulation of brain circuitry involved in incentive salience valuation and executive control. Imaging tasks will engage the incentive salience of smoking cues and non-smoking rewards and executive control functions to identify changes in functional activity within, and effective connectivity between, known salience and executive control brain circuitry. A novel fMRI task using specialized odor presentation equipment and fMRI sequences will assess neural cue reactivity to smoke odors.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Health Services Research
Official Title: Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes
Actual Study Start Date : February 20, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Very low nicotine content cigarettes
Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.
Drug: Very low nicotine content cigarettes
Very low nicotine content cigarettes

Placebo Comparator: Normal nicotine content cigarettes
Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.
Drug: Normal nicotine content cigarettes
Normal nicotine content cigarettes




Primary Outcome Measures :
  1. Changes in blood oxygen level dependent (BOLD) activity collected by fMRI [ Time Frame: Changes in BOLD from baseline to the 6-week visit. ]
    Effect of nicotine content on changes in task-related functional brain activation over 6-weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 21-60 years old
  • Smoke >5 cigarettes per day
  • >1 year of daily smoking
  • No quit attempt in prior month and not planning to quit smoking within next 3 months
  • Able to understand and consent to study procedures
  • High school or lower educational attainment or annual household income < $50,000
  • Plan to live in local area next 3 months
  • Women not pregnant or nursing and taking steps to avoid pregnancy
  • Able to read and write in English

Exclusion Criteria:

  • Use of non-cigarette tobacco products in the past 7 days
  • Use of illicit substances more than once a week in the past 3 months (excluding marijuana)
  • Current alcohol abuse impairing participation
  • MRI safety contraindications (e.g., metal implants, claustrophobia)
  • Unstable or significant medical conditions (e.g., COPD, coronary heart disease)
  • Major neurological conditions or brain trauma
  • Major surgeries planned in next 3 months
  • Use of smoking cessation medication in prior month (e.g., varenicline, patch)
  • Uncontrolled serious mental illness, suicidality, or inpatient psychiatric hospitalization in the past 6 months
  • Unwillingness to provide urine samples
  • Unwilling to smoke study assigned cigarettes for the remainder of the trial
  • Plans to move or take extended travel out of the area in the next 3 months
  • Any other condition or situation that would, in the investigator's opinion, make it unlikely that the participant could comply with the study protocol
  • Self-reported color blindness
  • Left-handedness
  • Smell dysfunction as determined via standardized assessment

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): NCT03612960


Locations
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United States, Pennsylvania
Penn State Health
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Andrea Hobkirk, PhD Milton S. Hershey Medical Center
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Responsible Party: Andrea Hobkirk, PhD, Assistant Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03612960    
Other Study ID Numbers: 9276
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Andrea Hobkirk, PhD, Milton S. Hershey Medical Center:
Tobacco
Nicotine
Smoking
Functional magnetic resonance imaging
Addiction
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action