N/A
N=34
Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes
Tobacco Dependence
Bottom Line
View on ClinicalTrials.gov: NCT03612960 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Change in Blood Oxygen Level Dependent (BOLD) Signal Collected by Functional Magnetic Resonance Imaging (fMRI) During Monetary Delay Discounting Task — 0.13; -0.16 Percent change — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Very low nicotine content cigarettes (Drug); Normal nicotine content cigarettes (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Blood Oxygen Level Dependent (BOLD) Signal Collected by Functional Magnetic Resonance Imaging (fMRI) During Monetary Delay Discounting Task |
0.13; -0.16 | <.001 sig |
| SECONDARY Change in Self-reported Cigarettes Per Day |
-5.1; 3.3 | .063 |
| SECONDARY Change in Percentage of Immediate Choices on Monetary Delay Discounting Task |
0.20; 1.57 | 0.890 |
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.
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
Data sourced from ClinicalTrials.gov (NCT03612960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.