NicWith: Nicotine Withdrawal and Reward Processing

• Sponsor: University of Oklahoma (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05041959
• Collaborator: Oklahoma State University (Other), National Institutes of Health (NIH) (NIH), National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.9
• Patients Per Site Per Month: 5.4

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Cigarette Smoking; Nicotine Dependence; Nicotine Withdrawal	Other: Smoking Abstinence; Other: Ad Lib Smoking	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Participants will abstain from smoking for 24 hours before one MRI scan and continue smoking as usual before the otherParticipants will abstain from smoking for 24 hours before one MRI scan and continue smoking as usual before the other
• Masking: None (Open Label)
• Masking Description: This is a smoking abstinence manipulation. No masking is possible.
• Primary Purpose: Basic Science
• Official Title: Nicotine Withdrawal and Reward Processing
• Actual Study Start Date: Jun 2, 2022
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: 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	Other: Smoking Abstinence; Participants will abstain from smoking for 24 hours
Other: 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.	Other: 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.

Outcome Measures

Primary Outcome Measures

1. Blood Oxygen Level Dependent (BOLD) Activation [Approximately 2-4 weeks]

   BOLD activation in brain reward network regions

2. Ecological Momentary Assessment (EMA) Pleasure Ratings [2-4 weeks]

   Anticipated and experienced pleasure based on self-report ratings acquired each day during the EMA phase

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Generally healthy

2. Age 21-55

3. Right-handed using a three-item scale

4. Daily smoker of ≥ 10 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 4 pleasurable activities they do not do concurrently with smoking or associate with smoking.

Exclusion Criteria:

1. Planning to quit smoking within the next 60 days

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

6. Marijuana will be tested for but will not exclusionary

7. Participants failing the toxicology screen may be allowed one re-screening attempt at the PI's discretion

8. 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

9. Current use of antipsychotic or stimulant medications.

10. Significant health problems or those that would impact scientific goals of the project, including (but not limited to):

11. Cancer, Bronchitis, Emphysema, COPD

12. Asthma or Breathing Problems

13. Insulin-Dependent Diabetes

14. Heart disease, angina, heart failure, serious arrhythmia or heart attack within the past 6 months

15. Systolic Blood Pressure > 160, Diastolic Blood Pressure > 100, HR > 115 bpm (one re-screen allowed).

16. Glaucoma, color blindness or an uncorrected vision problem

17. Significant hearing loss requiring the use of hearing aids or other hearing problems that would impact

18. History of stroke, brain tumor, seizure disorder, or traumatic brain injury

19. Metal implants (e.g. pacemaker, surgical pins, certain dental repairs), dental braces, or metal fragment injuries.

20. Claustrophobia

21. Weight > 300 pounds or unable to fit in the MRI scanner bore

22. Current depression, bipolar disorder, psychotic disorder or substance use disorder (moderate or severe only, mild is allowable at PI's discretion). SUD in remission is also allowable at PI's discretion

23. Pregnant, breastfeeding or planning to become pregnant during the course of the study (females)

24. 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

25. Irregular sleep-wake cycles (e.g. swing-shift work, unusual sleep pattern)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hardesty Center for Clinical Research and Neuroscience	Tulsa	Oklahoma	United States	74136

Sponsors and Collaborators

• University of Oklahoma
• Oklahoma State University
• National Institutes of Health (NIH)
• National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT05041959
• Other Study ID Numbers: K23DA042898
• First Posted: Sep 13, 2021
• Last Update Posted: Jun 15, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tobacco Use Disorder; Substance Withdrawal Syndrome

Study Results

No Results Posted as of Jun 15, 2022