Cigarette SmokingNicWithNCT03840694
Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior
A study testing Smoking Abstinence and Ad Lib Smoking in people with Cigarette Smoking and Nicotine Withdrawal, run by Duke University 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 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
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2019to 13 May 2021
- 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
- Right-handed
- Smoke >= 10 cigarettes per day
- Smoking regularly for >= 1 year
- Carbon Monoxide (CO) > 8 at screening (or urinary cotinine > 100)
- Own a compatible smartphone
- Able to read and understand English
- Able to identify at least 4 pleasurable activities they do not do concurrently with smoking or associate with smoking
Who cannot join
- Regular use of "roll your own" cigarettes
- Planning to quit smoking within the next 60 days
- Current or planned smoking cessation treatment
- Regular use of smokeless tobacco or other nicotine products
- Expired CO > 80 parts per million
- Breath alcohol > .000 at screening (re-attempts are allowed)
Show all 12Show fewer
- Positive toxicology screen for exclusionary drugs
- Use of exclusionary medications
- Significant medical problems
- Currently breastfeeding, pregnant, or planning to become pregnant
- Enrollment in another study utilizing Spectrum cigarettes within the last 3 months
- Irregular slee-wake cycles (e.g. swing-shift work, unusual sleep patterns)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University School of Medicine
Durham, North Carolina, 27705
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 Withdrawal
- Being tested
- Smoking Abstinence, Ad Lib Smoking
- Medical subject headings
- Cigarette Smoking
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) 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 1-3 weeks
Ecological Momentary Assessment (EMA) Pleasure Ratings
Anticipated and actual pleasure ratings acquired each day during EMA portion of study. Individual items are based on the 12-item Tripartite Pleasure Inventory (TPI). Participants rate their anticipated pleasure for activities they expect to engage in each day using a 0 (No pleasure) to 4 (Extreme pleasure) scale in the morning. They will then rate their actual experienced pleasure for activities they actually did engage in the evening using the same scale. Scores are summed across items for a theoretical range of 0-48.
Measured: 2-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start10 Sep 2019
- Primary completion13 May 2021
- Study completion13 May 2021
Why it stopped: PI leaving for another institution.
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.
- More trials run by Duke UniversityThe 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
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Jason A Oliver, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840694
- Sponsor's protocol ID
- Pro00101055
- Acronym
- NicWith
- Status last verified
- May 2021
- First submitted
- 12 Feb 2019
- Last updated
- 20 May 2021
- 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 the Office of Research Contracts 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 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior
- ClinicalTrials.gov ID
- NCT03840694
- Acronym / sponsor ID
- NicWith / Pro00101055
- Conditions
- Cigarette Smoking, Nicotine Withdrawal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI leaving for another institution.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), Food and Drug Administration (FDA)
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 13 May 2021 (actual)
- Study completion
- 13 May 2021 (actual)
- First posted
- 15 Feb 2019 (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
- Triple blind (participant, investigator, outcomes assessor)
- 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 (8 listed)
- Generally healthy
- Right-handed
- Smoke >= 10 cigarettes per day
- Smoking regularly for >= 1 year
- Carbon Monoxide (CO) > 8 at screening (or urinary cotinine > 100)
Key exclusion criteria (12 listed)
- Regular use of "roll your own" cigarettes
- Planning to quit smoking within the next 60 days
- Current or planned smoking cessation treatment
- Regular use of smokeless tobacco or other nicotine products
- Expired CO > 80 parts per million
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) 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 1-3 weeks
BOLD activation in brain reward network regions
Ecological Momentary Assessment (EMA) Pleasure Ratings
Time frame: 2-6 weeks
Anticipated and actual pleasure ratings acquired each day during EMA portion of study. Individual items are based on the 12-item Tripartite Pleasure Inventory (TPI). Participants rate their anticipated pleasure for activities they expect to engage in each day using a 0 (No pleasure) to 4 (Extreme pleasure) scale in the morning. They will then rate their actual experienced pleasure for activities they actually did engage in the evening using the same scale. Scores are summed across items for a theoretical range of 0-48.
Results and safety
The study was stopped early (reason given: PI leaving for another institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- 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 the Office of Research Contracts to obtain guidance regarding any required Data Use Agreements as needed.
Related trials for Cigarette Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Active, not recruiting
Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
Smoking
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.
Jason A Oliver, PhD principal investigator
Duke University
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 Withdrawal, run by Duke University 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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 20 May 2021. 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 was stopped early (reason given: PI leaving for another institution.). Results are not available in the source record.
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 1-3 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 20 May 2021.