NCT03612960

Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Very low nicotine content cigarettes	Very low nicotine content cigarettes
DRUG	Normal nicotine content cigarettes	Normal nicotine content cigarettes

Timeline

• Start date: 2020-02-20
• Primary completion: 2023-06-23
• Completion: 2023-06-23
• First posted: 2018-08-02
• Last updated: 2024-08-20
• Results posted: 2024-08-20

Locations

1 site across 1 country: United States