- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03612960
Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes
November 29, 2023 updated by: Andrea Hobkirk, PhD, Milton S. Hershey Medical Center
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 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.
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andrea Hobkirk, PhD
- Phone Number: 286415 717-531-0003
- Email: ahobkirk@pennstatehealth.psu.edu
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Penn State Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Description
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
- Access to computer with internet service that allows for Zoom
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
Normal nicotine content cigarettes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Changes in BOLD from baseline to the 6-week visit.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrea Hobkirk, PhD, Milton S. Hershey Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 20, 2020
Primary Completion (Actual)
June 23, 2023
Study Completion (Estimated)
January 1, 2024
Study Registration Dates
First Submitted
July 18, 2018
First Submitted That Met QC Criteria
August 1, 2018
First Posted (Actual)
August 2, 2018
Study Record Updates
Last Update Posted (Actual)
November 30, 2023
Last Update Submitted That Met QC Criteria
November 29, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Tobacco Use Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- 9276
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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