Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes

NCT03612960 | Completed Results DMC

• 2 other identifiers: 9276K23DA045081
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Dependence

Keywords

Tobacco; Nicotine; Smoking; Functional magnetic resonance imaging; Addiction

Outcome Measures

Primary Outcomes (1)

• Change in Blood Oxygen Level Dependent (BOLD) Signal Collected by Functional Magnetic Resonance Imaging (fMRI) During Monetary Delay Discounting Task

  Change from baseline to 6-weeks post-intervention in percentage of BOLD signal during hard vs. no choice conditions on a monetary delay discounting task in a left-sided cortical brain region encompassing the central opercular and dorsolateral prefrontal cortices.

  Change in BOLD signal from baseline to the 6-week visit.

Secondary Outcomes (2)

• Change in Self-reported Cigarettes Per Day

  Average cigarettes per day during week 1 subtracted from average cigarettes per day during week 6.

• Change in Percentage of Immediate Choices on Monetary Delay Discounting Task

  Changes from baseline to 6-weeks post intervention.

Study Arms (2)

Very low nicotine content cigarettes

EXPERIMENTAL

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

Drug: Very low nicotine content cigarettes

Normal nicotine content cigarettes

PLACEBO COMPARATOR

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

Drug: Normal nicotine content cigarettes

Interventions

Very low nicotine content cigarettes DRUG

Very low nicotine content cigarettes

Very low nicotine content cigarettes

Normal nicotine content cigarettes DRUG

Normal nicotine content cigarettes

Normal nicotine content cigarettes

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Penn State Health

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Behavior, Addictive

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Compulsive Behavior; Impulsive Behavior

Limitations and Caveats

Exclusion criteria was revised throughout the project (e.g., removed menthol use as exclusion) to accommodate challenges in recruitment.

Results Point of Contact

• Title: Dr. Andrea Hobkirk
• Organization: Pennsylvania State University

ahobkirk@pennstatehealth.psu.edu

7175310003

Study Officials

• Andrea Hobkirk, PhD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 2, 2018
• Study Start: February 20, 2020
• Primary Completion: June 23, 2023
• Study Completion: June 23, 2023
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)