Cigarette SmokingNicWithNCT05041959
Nicotine Withdrawal and Reward Processing
A study testing Smoking Abstinence and Ad Lib Smoking in people with Cigarette Smoking and Nicotine Dependence, run by University of Oklahoma at 1 site in United States.
Trial summary
This study is designed to find out how smoking affects the way the brain responds to pleasure and how this impacts smokers' behavior. Participants will complete three sessions. The first session will be a screening and training visit to determine final eligibility. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking, Nicotine Dependence, Nicotine Withdrawal
- What is being tested?
- Smoking Abstinence and Ad Lib Smoking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2022to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy
- Age 21-55
- Right-handed using a three-item scale
- Daily smoker of ≥ 6 cigarettes/day
- Smoking regularly for ≥ 1 year
- Have a smartphone capable of running the MetricWire application
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- Able to read and understand English
- Able to identify at least 6 pleasurable activities they do not do concurrently with smoking or associate with smoking.
- Able to identify at least 6 unique locations/scenarios they do associate with smoking
Who cannot join
- Planning to quit smoking within the next 60 days
- Currently seeking or receiving treatment for smoking cessation
- Use of smokeless tobacco, nicotine replacement products or electronic cigarettes more than 5 days in the past month.
- Breath alcohol level ≥.001. Participants may be allowed one reschedule at the discretion of the PI or other study staff.
- Positive toxicology screen for illicit drugs
- Marijuana will be tested for but will not be exclusionary
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- Participants failing the toxicology screen may be allowed one re-screening attempt at the PI's discretion
- Participants with valid prescriptions who report using the medication as directed and meet all other eligibility criteria may be allowed to participate at the PI's discretion
- Current use of antipsychotic or stimulant medications.
- Significant health problems or those that would impact scientific goals of the project, including (but not limited to):
- Cancer, Bronchitis, Emphysema, COPD
- Asthma or Breathing Problems
- Insulin-Dependent Diabetes
- Heart disease, angina, heart failure, serious arrhythmia or heart attack within the past 6 months
- Systolic Blood Pressure > 160, Diastolic Blood Pressure > 100, HR > 115 bpm (one re-screen allowed).
- Glaucoma, color blindness or an uncorrected vision problem
- Significant hearing loss requiring the use of hearing aids or other hearing problems that would impact
- History of stroke, brain tumor, seizure disorder, or traumatic brain injury
- Metal implants (e.g. pacemaker, surgical pins, certain dental repairs), dental braces, or metal fragment injuries.
- Claustrophobia
- Weight > 350 pounds or unable to fit in the MRI scanner bore
- Current psychotic disorder, alcohol use disorder or drug use disorder for drugs other than cannabis (moderate or severe only, mild is allowable at PI's discretion). AUD and DUD in remission are also allowable at PI's discretion.
- Pregnant, breastfeeding or planning to become pregnant during the course of the study (females)
- Current enrollment in another smoking research study or having participated in a study involving daily use of Spectrum cigarettes or other reduced nicotine products within the past three months
- Irregular sleep-wake cycles (e.g. swing-shift work, unusual sleep pattern)
Trial locations and contacts
1 site in 1 country.
United States1 site
Hardesty Center for Clinical Research and Neuroscience
Tulsa, Oklahoma, 74136
About this study
This study is designed to find out how smoking affects the way the brain responds to pleasure and how this impacts smokers' behavior. Participants will complete three sessions. The first session will be a screening and training visit to determine final eligibility. Eligible participants will work with a researcher to develop brief scripts about times when they smoke and do other activities. Next, participants will attend two magnetic resonance imaging (MRI) scans - one after abstaining from smoking for 24 hours and the other after smoking as usual. After the second MRI, participants will answer questions on their phone every day for two weeks.
- Conditions
- Cigarette Smoking, Nicotine Dependence, Nicotine Withdrawal
- Being tested
- Smoking Abstinence, Ad Lib Smoking
- Medical subject headings
- Cigarette Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking AbstinenceOther
Participants will abstain from smoking for 24 hours
Ad Lib SmokingOther
Participants will continue smoking as usual (i.e. ad lib) in the day leading up to the scan and smoke one cigarette of their own brand immediately prior to scanning.
| Study group | Role | What they receive |
|---|---|---|
| Smoking Abstinence | Other | Participants will abstain from smoking for 24 hours before one MRI scan. Smoking abstinence will be confirmed using exhaled carbon monoxide breath testing Receives: Other: Smoking Abstinence |
| Ad Lib Smoking | Other | Participants will continue smoking as usual (i.e. "ad lib") before one MRI scan and smoke one additional cigarette immediately prior to scanning. Continued smoking will be confirmed using exhaled carbon monoxide breath testing. Receives: Other: Ad Lib Smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygen Level Dependent (BOLD) Activation
BOLD activation in brain reward network regions
Measured: Approximately 2-4 weeks
Ecological Momentary Assessment (EMA) Pleasure Ratings
Anticipated and experienced pleasure based on self-report ratings acquired each day during the EMA phase
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start2 Jun 2022
- Primary completion29 Mar 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will abstain from smoking for 24 hours before one MRI scan and continue smoking as usual before the other
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma State University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041959
- Sponsor's protocol ID
- K23DA042898
- Other IDs
- K23DA042898
- Acronym
- NicWith
- Status last verified
- May 2024
- First submitted
- 3 Sep 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Detailed protocols, datasets and additional information will be available from the Principal Investigator and research team upon request. In order to maintain compliance with the Health Insurance Portability and Accountability Act (HIPAA) requirements, as well as university data security policies, all data will be anonymized according to HIPAA guidelines prior to being shared. Individual participant scripts will not be made publicly available due to privacy concerns and because this could impact the nature of information participants were willing to provide for scripts. Data will be provided in widely accessible formats for both self-report and imaging data. We will work with relevant administrative offices to obtain guidance regarding any required Data Use Agreements as needed.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Withdrawal and Reward Processing
- ClinicalTrials.gov ID
- NCT05041959
- Acronym / sponsor ID
- NicWith / K23DA042898
- Conditions
- Cigarette Smoking, Nicotine Dependence, Nicotine Withdrawal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Oklahoma State University, National Institute on Drug Abuse (NIDA)
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to find out how smoking affects the way the brain responds to pleasure and how this impacts smokers' behavior. Participants will complete three sessions. The first session will be a screening and training visit to determine final eligibility. Eligible participants will work with a researcher to develop brief scripts about times when they smoke and do other activities. Next, participants will attend two magnetic resonance imaging (MRI) scans - one after abstaining from smoking for 24 hours and the other after smoking as usual. After the second MRI, participants will answer questions on their phone every day for two weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will abstain from smoking for 24 hours before one MRI scan and continue smoking as usual before the other
| Arm | Type | Receives |
|---|---|---|
| Smoking Abstinence | Other | Other: Smoking AbstinenceParticipants will abstain from smoking for 24 hours before one MRI scan. Smoking abstinence will be confirmed using exhaled carbon monoxide breath testing |
| Ad Lib Smoking | Other | Other: Ad Lib SmokingParticipants will continue smoking as usual (i.e. "ad lib") before one MRI scan and smoke one additional cigarette immediately prior to scanning. Continued smoking will be confirmed using exhaled carbon monoxide breath testing. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Generally healthy
- Age 21-55
- Right-handed using a three-item scale
- Daily smoker of ≥ 6 cigarettes/day
- Smoking regularly for ≥ 1 year
Key exclusion criteria (25 listed)
- Planning to quit smoking within the next 60 days
- Currently seeking or receiving treatment for smoking cessation
- Use of smokeless tobacco, nicotine replacement products or electronic cigarettes more than 5 days in the past month.
- Breath alcohol level ≥.001. Participants may be allowed one reschedule at the discretion of the PI or other study staff.
- Positive toxicology screen for illicit drugs
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 |
|---|---|---|
| Smoking AbstinenceParticipants will abstain from smoking for 24 hours | Other | Smoking Abstinence |
| Ad Lib SmokingParticipants will continue smoking as usual (i.e. ad lib) in the day leading up to the scan and smoke one cigarette of their own brand immediately prior to scanning. | Other | Ad Lib Smoking |
Primary outcome
Blood Oxygen Level Dependent (BOLD) Activation
Time frame: Approximately 2-4 weeks
BOLD activation in brain reward network regions
Ecological Momentary Assessment (EMA) Pleasure Ratings
Time frame: 2-4 weeks
Anticipated and experienced pleasure based on self-report ratings acquired each day during the EMA phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Yes. Detailed protocols, datasets and additional information will be available from the Principal Investigator and research team upon request. In order to maintain compliance with the Health Insurance Portability and Accountability Act (HIPAA) requirements, as well as university data security policies, all data will be anonymized according to HIPAA guidelines prior to being shared. Individual participant scripts will not be made publicly available due to privacy concerns and because this could impact the nature of information participants were willing to provide for scripts. Data will be provided in widely accessible formats for both self-report and imaging data. We will work with relevant administrative offices to obtain guidance regarding any required Data Use Agreements as needed.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Abstinence and Ad Lib Smoking in people with Cigarette Smoking and Nicotine Dependence, run by University of Oklahoma 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 9 inclusion and 25 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 8 May 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood Oxygen Level Dependent (BOLD) Activation (time frame: Approximately 2-4 weeks). The study lists 2 primary outcomes in all. 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 8 May 2024.