Clinical trial NCT03612960: Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes
Official title: Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: Tobacco
Nicotine
Smoking
Functional magnetic resonance imaging
Addiction
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-08-02
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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
* 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., chronic obstructive pulmonary disorder, 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

Primary outcomes:
measure: Change in Blood Oxygen Level Dependent (BOLD) Signal Collected by Functional Magnetic Resonance Imaging (fMRI) During Monetary Delay Discounting Task
timeFrame: Change in BOLD signal from baseline to the 6-week visit.
Secondary outcomes:
measure: Change in Self-reported Cigarettes Per Day
timeFrame: Average cigarettes per day during week 1 subtracted from average cigarettes per day during week 6.
measure: Change in Percentage of Immediate Choices on Monetary Delay Discounting Task
timeFrame: Changes from baseline to 6-weeks post intervention.
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Health
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Andrea Hobkirk, PhD
role: PRINCIPAL_INVESTIGATOR
References: