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

Cigarette Smoking Clinical Trial

— NicWith  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03840694
• Other study ID #: Pro00101055
• Status: Terminated
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: May 13, 2021

Study information

• Verified date: May 2021
• Source: Duke University
• Contact: n/a
• 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: Terminated
• Enrollment: 21
• Est. completion date: May 13, 2021
• Est. primary completion date: May 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cigarette Smoking
• Nicotine Withdrawal
• Substance Withdrawal Syndrome

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) and smoke one cigarette of their own brand immediately prior to scanning.

Locations

Country	Name	City	State
United States	Duke University School of Medicine	Durham	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	Food and Drug Administration (FDA), National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

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 1-3 weeks
Primary	Ecological Momentary Assessment (EMA) Pleasure Ratings	Anticipated and actual pleasure ratings acquired each day during EMA portion of study. Individual items are based on the 12-item Tripartite Pleasure Inventory (TPI). Participants rate their anticipated pleasure for activities they expect to engage in each day using a 0 (No pleasure) to 4 (Extreme pleasure) scale in the morning. They will then rate their actual experienced pleasure for activities they actually did engage in the evening using the same scale. Scores are summed across items for a theoretical range of 0-48.	2-6 weeks