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Effort: Effects of Smoking State on Decision Making

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT04826276
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
10
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: smoking abstinence
  • Other: smoking satiety
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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state) and to abstain from using all tobacco/nicotine for 12 hours before the other fMRI study visit (abstinence and/or withdrawn state). The order of the satiated and abstinence/withdrawn study visits will be randomized and counterbalanced across participants.Participants will be instructed to smoke as usual before one fMRI study visit (satiated state) and to abstain from using all tobacco/nicotine for 12 hours before the other fMRI study visit (abstinence and/or withdrawn state). The order of the satiated and abstinence/withdrawn study visits will be randomized and counterbalanced across participants.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effects of Smoking State on Effort-based Decision Making
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Effort based decision making [through study completion, an average of 1 year]

    number of high effort selections

  2. Distress tolerance behavior [through study completion, an average of 1 year]

    duration on measures of distress tolerance

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wake Forest University School of Medicine Winston-Salem North Carolina United States 27101

Sponsors and Collaborators

  • Wake Forest University Health Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT04826276
Other Study ID Numbers:
  • IRB00079949
First Posted:
Apr 1, 2021
Last Update Posted:
Jul 11, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wake Forest University Health Sciences
Decision making

Study Results

No Results Posted as of Jul 11, 2022