Effects of Smoking State on Decision Making (Effort)

June 1, 2023 updated by: Wake Forest University Health Sciences

Effects of Smoking State on Effort-based Decision Making

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27101
        • Wake Forest University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: smoking abstinence
participants will be asked to not smoke for at least 12 hours
Other: smoking satiety
participants will be asked to smoke as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effort based decision making
Time Frame: through study completion, an average of 1 year
number of high effort selections
through study completion, an average of 1 year
Distress tolerance behavior
Time Frame: through study completion, an average of 1 year
duration on measures of distress tolerance
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Merideth Addicott, PhD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

March 28, 2023

Study Completion (Actual)

March 28, 2023

Study Registration Dates

First Submitted

March 26, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00079949

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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