Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 7R21DA045970-03 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
Adult smokers will be tested using behavioral and neuroimaging measures after smoking as usual and after overnight abstinence.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smoking abstinence | Other | participants will be asked to not smoke for at least 12 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effort Based Decision Making | number of high effort selections | approximately 2 weeks |
| Distress Tolerance Behavior | duration on measures of distress tolerance | approximately 2 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Merideth Addicott, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27101 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Satiated/Withdrawn | first satiated then withdrawn |
| FG001 | Withdrawn/Satiated | first tobacco/nicotine withdrawn then tobacco/nicotine satiated |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Satiated/Withdrawn | first satiated then withdrawn |
| BG001 | Withdrawn/Satiated | first withdrawn then satiated |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effort Based Decision Making | number of high effort selections | Posted | Mean | Standard Deviation | high effort selections | approximately 2 weeks |
|
|
from enrollment until study completion, up to 6 weeks
Arms/groups are not combined since the study manipulation did not increase the risk of adverse events above what someone would experience in day-to-day life
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Withdrawn Then Satiated | withdrawn then satiated | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Merideth Addicott | Wake Forest University School of Medicine | 336-716-7792 | merideth.addicott@wfusm.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2022 | Apr 1, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 10, 2022 | Jun 1, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| smoking satiety |
| Other |
participants will be asked to smoke as usual |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| cigarettes per day | Mean | Standard Deviation | cigarettes per day |
|
|
| Primary | Distress Tolerance Behavior | duration on measures of distress tolerance | Posted | Mean | Standard Deviation | secs | approximately 2 weeks |
|
|
|
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Satiated Then Withdrawn | satiated then withdrawn | 0 | 3 | 0 | 3 | 0 | 2 |
Not provided
Not provided