Effects of Smoking State on Decision Making

NCT ID: NCT04826276

Last Updated: 2023-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-03-28

Brief Summary

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Adult smokers will be tested using behavioral and neuroimaging measures after smoking as usual and after overnight abstinence.

Detailed Description

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Conditions

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Behavior

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants will be instructed to smoke as usual before one fMRI study visit (satiated state) and to abstain from using all tobacco/nicotine for 12 hours before the other fMRI study visit (abstinence and/or withdrawn state). The order of the satiated and abstinence/withdrawn study visits will be randomized and counterbalanced across participants.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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All Subjects

for the abstinence intervention, 12+ hours after smoking will be assessed before assessments following smoking as normal

For the satiated intervention, smoking as normal will be assessed first before assessments following 12+ hours of abstinence from smoking

Group Type EXPERIMENTAL

smoking abstinence

Intervention Type OTHER

participants will be asked to not smoke for at least 12 hours

smoking satiety

Intervention Type OTHER

participants will be asked to smoke as usual

Interventions

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smoking abstinence

participants will be asked to not smoke for at least 12 hours

Intervention Type OTHER

smoking satiety

participants will be asked to smoke as usual

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged 18-55 years
* Smokes cigarettes or e-cigarettes
* Negative urine drug screen

Exclusion Criteria

* Unstable or serious medical or mental health condition
* History of serious head trauma
* Pregnancy
* Unsuitable for MRI
* Weight \> 350 pounds (maximum allowed for MRI)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Merideth Addicott, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB00079949

Identifier Type: -

Identifier Source: org_study_id

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