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

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 Withdrawal	Other: Smoking Abstinence Other: Ad Lib Smoking	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

21 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 other.Participants will abstain from smoking for 24 hours before one MRI scan and continue smoking as usual before the other.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Sep 10, 2019

Actual Primary Completion Date :

May 13, 2021

Actual Study Completion Date :

May 13, 2021

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

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

Outcome Measures

Primary Outcome Measures

Blood Oxygen Level Dependent (BOLD) Activation [Approximately 1-3 weeks]
BOLD activation in brain reward network regions
Ecological Momentary Assessment (EMA) Pleasure Ratings [2-6 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University School of Medicine	Durham	North Carolina	United States	27705

Sponsors and Collaborators

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

Investigators

Principal Investigator: Jason A Oliver, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Duke University

ClinicalTrials.gov Identifier:

NCT03840694

Other Study ID Numbers:

Pro00101055

First Posted:

Feb 15, 2019

Last Update Posted:

May 20, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Substance Withdrawal Syndrome

Study Results

No Results Posted as of May 20, 2021