NCT04826276

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2023

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

May 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

March 26, 2021

Results QC Date

April 6, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

Decision making

Outcome Measures

Primary Outcomes (2)

  • Effort Based Decision Making

    number of high effort selections

    approximately 2 weeks

  • Distress Tolerance Behavior

    duration on measures of distress tolerance

    approximately 2 weeks

Study Arms (1)

All Subjects

EXPERIMENTAL

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 abstinenceOther: smoking satiety

Interventions

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

All Subjects

participants will be asked to smoke as usual

All Subjects

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27101, United States

Location

MeSH Terms

Conditions

Behavior

Results Point of Contact

Title
Dr. Merideth Addicott
Organization
Wake Forest University School of Medicine

Study Officials

  • Merideth Addicott, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2021

First Posted

April 1, 2021

Study Start

September 1, 2022

Primary Completion

March 28, 2023

Study Completion

March 28, 2023

Last Updated

May 1, 2026

Results First Posted

May 1, 2026

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations