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Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes

Primary Purpose

Tobacco Dependence

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Very low nicotine content cigarettes
Normal nicotine content cigarettes
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tobacco Dependence focused on measuring Tobacco, Nicotine, Smoking, Functional magnetic resonance imaging, Addiction

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Very low nicotine content cigarettes

Normal nicotine content cigarettes

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in blood oxygen level dependent (BOLD) activity collected by fMRI
Effect of nicotine content on changes in task-related functional brain activation over 6-weeks

Secondary Outcome Measures

Full Information

First Posted
July 18, 2018
Last Updated
July 24, 2023
Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03612960
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
June 23, 2023 (Actual)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institutes of Health (NIH)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
Tobacco, Nicotine, Smoking, Functional magnetic resonance imaging, Addiction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Very low nicotine content cigarettes
Arm Type
Experimental
Arm Description
Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.
Arm Title
Normal nicotine content cigarettes
Arm Type
Placebo Comparator
Arm Description
Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.
Intervention Type
Drug
Intervention Name(s)
Very low nicotine content cigarettes
Intervention Description
Very low nicotine content cigarettes
Intervention Type
Drug
Intervention Name(s)
Normal nicotine content cigarettes
Intervention Description
Normal nicotine content cigarettes
Primary Outcome Measure Information:
Title
Changes in blood oxygen level dependent (BOLD) activity collected by fMRI
Description
Effect of nicotine content on changes in task-related functional brain activation over 6-weeks
Time Frame
Changes in BOLD from baseline to the 6-week visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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., 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Hobkirk, PhD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Health
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes

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