Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior

NCT ID: NCT03840694

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-10
• Study Completion Date: 2021-05-13

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.

Conditions

Cigarette Smoking; Nicotine Withdrawal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: OTHER

Smoking Abstinence

Intervention Type: OTHER

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.

Group Type: OTHER

Ad Lib Smoking

Intervention Type: OTHER

Participants will continue smoking as usual (i.e. ad lib) and smoke one cigarette of their own brand immediately prior to scanning.

Interventions

Smoking Abstinence

Participants will abstain from smoking for 24 hours.

Intervention Type: OTHER

Ad Lib Smoking

Participants will continue smoking as usual (i.e. ad lib) and smoke one cigarette of their own brand immediately prior to scanning.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• 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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason A Oliver, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University School of Medicine

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00101055

Identifier Type: -

Identifier Source: org_study_id