Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes

NCT ID: NCT03612960

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-20
• Study Completion Date: 2023-06-23

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.

Conditions

Tobacco Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Very low nicotine content cigarettes

Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.

Group Type: EXPERIMENTAL

Very low nicotine content cigarettes

Intervention Type: DRUG

Very low nicotine content cigarettes

Normal nicotine content cigarettes

Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.

Group Type: PLACEBO_COMPARATOR

Normal nicotine content cigarettes

Intervention Type: DRUG

Normal nicotine content cigarettes

Interventions

Very low nicotine content cigarettes

Very low nicotine content cigarettes

Intervention Type: DRUG

Normal nicotine content cigarettes

Normal nicotine content cigarettes

Intervention Type: DRUG

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Andrea Hobkirk, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Hobkirk, PhD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Health

Hershey, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K23DA045081

Identifier Type: NIH

Identifier Source: secondary_id

View Link

9276

Identifier Type: -

Identifier Source: org_study_id