Tobacco DependenceNCT03612960
Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes
A study testing Very low nicotine content cigarettes and Normal nicotine content cigarettes in people with Tobacco Dependence, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Very low nicotine content cigarettes and Normal nicotine content cigarettes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2020to 23 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Very low nicotine content cigarettes, Normal nicotine content cigarettes
- Keywords
- Tobacco, Nicotine, Smoking, Functional magnetic resonance imaging, Addiction
- Medical subject headings
- Tobacco Use Disorder, Smoking, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low nicotine content cigarettesDrug
Very low nicotine content cigarettes
Normal nicotine content cigarettesDrug
Normal nicotine content cigarettes
| Study group | Role | What they receive |
|---|---|---|
| Very low nicotine content cigarettes | Experimental | Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes. Receives: 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. Receives: Drug: Normal nicotine content cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in BOLD signal from baseline to the 6-week visit.
Secondary outcomes (2)
Change in Self-reported Cigarettes Per Day
Difference in week 6 mean minus week 1 mean of cigarettes used per day reported by participants on daily logs.
Measured: 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
A difference score (6-weeks minus baseline) of the percentage of trials where the immediate (vs. delayed) monetary option was chosen out of all task trials during the monetary delay discounting task that was completed outside of the MRI scan.
Measured: Changes from baseline to 6-weeks post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start20 Feb 2020
- Primary completion23 Jun 2023
- Study completion23 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Andrea Hobkirk, PhD, Milton S. Hershey Medical Center
- Investigators
- Andrea Hobkirk, PhD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612960
- Sponsor's protocol ID
- 9276
- Other IDs
- K23DA045081
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2018
- Last updated
- 20 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes
- ClinicalTrials.gov ID
- NCT03612960
- Acronym / sponsor ID
- 9276
- Conditions
- Tobacco Dependence
- Keywords
- Tobacco, Nicotine, Smoking, Functional magnetic resonance imaging, Addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Posted 20 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Very low nicotine content cigarettes | Experimental | Drug: Very low nicotine content cigarettesResearch cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes. |
| Normal nicotine content cigarettes | Placebo comparator | Drug: Normal nicotine content cigarettesResearch cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very low nicotine content cigarettesVery low nicotine content cigarettes | Drug | Very low nicotine content cigarettes |
| Normal nicotine content cigarettesNormal nicotine content cigarettes | Drug | Normal nicotine content cigarettes |
Primary outcome
Change in Blood Oxygen Level Dependent (BOLD) Signal Collected by Functional Magnetic Resonance Imaging (fMRI) During Monetary Delay Discounting Task
Time frame: Change in BOLD signal from baseline to the 6-week visit.
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.
2 secondary outcomes
Change in Self-reported Cigarettes Per Day
Time frame: 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
Time frame: Changes from baseline to 6-weeks post intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Hobkirk, PhD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very low nicotine content cigarettes and Normal nicotine content cigarettes in people with Tobacco Dependence, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Oxygen Level Dependent (BOLD) Signal Collected by Functional Magnetic Resonance Imaging (fMRI) During Monetary Delay Discounting Task (time frame: Change in BOLD signal from baseline to the 6-week visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.