Nicotine Withdrawal and Reward Processing

Nicotine Dependence Clinical Trial

— NicWith  

Official title:

Nicotine Withdrawal and Reward Processing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05041959
• Other study ID #: K23DA042898
• Secondary ID: K23DA042898
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University of Oklahoma
• Contact: Jason A Oliver, PhD
• Phone: 405-271-8001
• Email: Jason-Oliver[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Generally healthy

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:

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

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)

Related Conditions & MeSH terms

• Cigarette Smoking
• Nicotine Dependence
• Nicotine Withdrawal
• Substance Withdrawal Syndrome
• Tobacco Use Disorder

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Hardesty Center for Clinical Research and Neuroscience	Tulsa	Oklahoma

Sponsors (3)

Lead Sponsor	Collaborator
University of Oklahoma	National Institute on Drug Abuse (NIDA), Oklahoma State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Oxygen Level Dependent (BOLD) Activation	BOLD activation in brain reward network regions	Approximately 2-4 weeks
Primary	Ecological Momentary Assessment (EMA) Pleasure Ratings	Anticipated and experienced pleasure based on self-report ratings acquired each day during the EMA phase	2-4 weeks