Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2022-06-02
2024-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Smoking Abstinence
Participants will abstain from smoking for 24 hours before one MRI scan. Smoking abstinence will be confirmed using exhaled carbon monoxide breath testing
Smoking Abstinence
Participants will abstain from smoking for 24 hours
Ad Lib Smoking
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.
Ad Lib Smoking
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.
Interventions
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Smoking Abstinence
Participants will abstain from smoking for 24 hours
Ad Lib Smoking
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.
Eligibility Criteria
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Inclusion Criteria
2. Age 21-55
3. Right-handed using a three-item scale
4. Daily smoker of ≥ 6 cigarettes/day
5. Smoking regularly for ≥ 1 year
6. Have a smartphone capable of running the MetricWire application
7. Able to read and understand English
8. Able to identify at least 6 pleasurable activities they do not do concurrently with smoking or associate with smoking.
9. Able to identify at least 6 unique locations/scenarios they do associate with smoking
Exclusion Criteria
2. Currently seeking or receiving treatment for smoking cessation
3. Use of smokeless tobacco, nicotine replacement products or electronic cigarettes more than 5 days in the past month.
4. Breath alcohol level ≥.001. Participants may be allowed one reschedule at the discretion of the PI or other study staff.
5. Positive toxicology screen for illicit drugs
1. Marijuana will be tested for but will not be exclusionary
2. Participants failing the toxicology screen may be allowed one re-screening attempt at the PI's discretion
3. 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
6. Current use of antipsychotic or stimulant medications.
7. Significant health problems or those that would impact scientific goals of the project, including (but not limited to):
1. Cancer, Bronchitis, Emphysema, COPD
2. Asthma or Breathing Problems
3. Insulin-Dependent Diabetes
4. Heart disease, angina, heart failure, serious arrhythmia or heart attack within the past 6 months
5. Systolic Blood Pressure \> 160, Diastolic Blood Pressure \> 100, HR \> 115 bpm (one re-screen allowed).
6. Glaucoma, color blindness or an uncorrected vision problem
7. Significant hearing loss requiring the use of hearing aids or other hearing problems that would impact
8. History of stroke, brain tumor, seizure disorder, or traumatic brain injury
9. Metal implants (e.g. pacemaker, surgical pins, certain dental repairs), dental braces, or metal fragment injuries.
10. Claustrophobia
11. Weight \> 350 pounds or unable to fit in the MRI scanner bore
12. 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.
13. Pregnant, breastfeeding or planning to become pregnant during the course of the study (females)
8. 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
9. Irregular sleep-wake cycles (e.g. swing-shift work, unusual sleep pattern)
21 Years
55 Years
ALL
Yes
Sponsors
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Oklahoma State University
OTHER
National Institute on Drug Abuse (NIDA)
NIH
University of Oklahoma
OTHER
Responsible Party
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Locations
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Hardesty Center for Clinical Research and Neuroscience
Tulsa, Oklahoma, United States
Countries
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Other Identifiers
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