BehaviorEffortNCT04826276
Effects of Smoking State on Decision Making
A study testing smoking abstinence and smoking satiety in people with Behavior, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Adult smokers will be tested using behavioral and neuroimaging measures after smoking as usual and after overnight abstinence. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior
- What is being tested?
- smoking abstinence and smoking satiety
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 28 Mar 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-55 years
- Smokes cigarettes or e-cigarettes
- Negative urine drug screen
Who cannot join
- Unstable or serious medical or mental health condition
- History of serious head trauma
- Pregnancy
- Unsuitable for MRI
- Weight > 350 pounds (maximum allowed for MRI)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27101
About this study
Official title: Effects of Smoking State on Effort-based Decision Making
Adult smokers will be tested using behavioral and neuroimaging measures after smoking as usual and after overnight abstinence.
- Conditions
- Behavior
- Being tested
- smoking abstinence, smoking satiety
- Keywords
- Decision making
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking abstinenceOther
participants will be asked to not smoke for at least 12 hours
smoking satietyOther
participants will be asked to smoke as usual
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | Experimental | for the abstinence intervention, 12+ hours after smoking will be assessed before assessments following smoking as normal
For the satiated intervention, smoking as normal will be assessed first before assessments following 12+ hours of abstinence from smoking Receives: Other: smoking abstinence; Other: smoking satiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effort Based Decision Making
number of high effort selections
Measured: approximately 2 weeks
Distress Tolerance Behavior
duration on measures of distress tolerance
Measured: approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Sep 2022
- Primary completion28 Mar 2023
- Study completion28 Mar 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 BehaviorStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be instructed to smoke as usual before one fMRI study visit (satiated state) and to abstain from using all tobacco/nicotine for 12 hours before the other fMRI study visit (abstinence and/or withdrawn state). The order of the satiated and abstinence/withdrawn study visits will be randomized and counterbalanced across participants.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Merideth Addicott, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826276
- Sponsor's protocol ID
- IRB00079949
- Other IDs
- 7R21DA045970-03
- Acronym
- Effort
- Status last verified
- Sep 2022
- First submitted
- 26 Mar 2021
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Smoking State on Effort-based Decision Making
- ClinicalTrials.gov ID
- NCT04826276
- Acronym / sponsor ID
- Effort / IRB00079949
- Conditions
- Behavior
- Keywords
- Decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adult smokers will be tested using behavioral and neuroimaging measures after smoking as usual and after overnight abstinence.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be instructed to smoke as usual before one fMRI study visit (satiated state) and to abstain from using all tobacco/nicotine for 12 hours before the other fMRI study visit (abstinence and/or withdrawn state). The order of the satiated and abstinence/withdrawn study visits will be randomized and counterbalanced across participants.
| Arm | Type | Receives |
|---|---|---|
| All Subjects | Experimental | Other: smoking abstinence, Other: smoking satietyfor the abstinence intervention, 12+ hours after smoking will be assessed before assessments following smoking as normal For the satiated intervention, smoking as normal will be assessed first before assessments following 12+ hours of abstinence from smoking |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-55 years
- Smokes cigarettes or e-cigarettes
- Negative urine drug screen
Key exclusion criteria (5 listed)
- Unstable or serious medical or mental health condition
- History of serious head trauma
- Pregnancy
- Unsuitable for MRI
- Weight > 350 pounds (maximum allowed for MRI)
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 be asked to not smoke for at least 12 hours | Other | All Subjects |
| smoking satietyparticipants will be asked to smoke as usual | Other | All Subjects |
Primary outcome
Effort Based Decision Making
Time frame: approximately 2 weeks
number of high effort selections
Distress Tolerance Behavior
Time frame: approximately 2 weeks
duration on measures of distress tolerance
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- 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.
Merideth Addicott, PhD principal investigator
Wake Forest University Health Sciences
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 smoking satiety in people with Behavior, run by Wake Forest University Health Sciences 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 3 inclusion and 5 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 1 May 2026. 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?
Yes. Results are posted in the registry (first posted 1 May 2026). 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?
Effort Based Decision Making (time frame: approximately 2 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 1 May 2026.