Alcohol Drinking Clinical Trial
Official title:
Measuring the Neuroimmune Response to Alcohol
Verified date | October 2023 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study uses positron emission tomography imaging of the 18-kDa translocator protein to measure the brain's immune response to alcohol.
Status | Completed |
Enrollment | 14 |
Est. completion date | November 20, 2021 |
Est. primary completion date | November 20, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 50 Years |
Eligibility | General Inclusion Criteria: 1. Men and women, aged 21-50 years 2. Willing and able to give voluntary written informed consent 3. Able to read and write English and communicate effectively with the investigators, and comply with all study requirements, restrictions, and directions of the clinic staff 4. AUD Subjects will meet DSM-5 criteria for current Alcohol Use Disorder 5. Moderate Drinkers will report consuming alcohol on at least one occasion in the past three months that would result in an estimated blood alcohol level greater than 100 mg/dl but not meet DSM-5 criteria for AUD. This is to ensure that subjects have prior drinking exposure consistent with levels proposed in this study. Prospective subjects will be asked to recall the heaviest two days of drinking in the previous three months. Using this information, approximate BAC will be calculated for those prior episodes. 6. Medically healthy upon physical examination and laboratory testing. General Exclusion Criteria: 1. Individuals whom the investigators deem may not be able to comply with alcohol abstinence for 48 hours prior to study day. 2. Current significant medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology. 3. History of or current neurological or significant psychiatric disorder such as schizophrenia or bipolar disorder (DSM-5 Axis 1). 4. Other substance use disorder with the exception of nicotine dependence in smokers as assessed with the SCID or positive urine screen for drugs of abuse. 5. Participants with any significant current medical conditions that would contraindicate the consumption of alcohol, such as history of neurological trauma or diseases, seizures, delirium or hallucinations, hepatic, or other unstable medical conditions. 6. Current suicidal or homicidal intent or behavior, or history of suicidal or homicidal behavior. 7. No barbiturates or other known microsomal enzyme induces or inhibitors in the past month. 8. History of significant head trauma. 9. Women who are pregnant or nursing or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives [oral, implant, injection, patch, or ring], contraceptive sponge, double barrier [diaphragm or condom plus spermicide], or IUD). 10. Regular or current significant use of any prescription, herbal or illegal psychotropic medications (e.g., antidepressants, antipsychotics, anxiolytics, ecstasy) in the past 6 mo, with no current illegal drug use confirmed by urine toxicology (except for cocaine and marijuana when relevant). 11. Have MRI-incompatible implants and other contraindications for MRI, such as a pacemaker, artificial joints, non-removable body piercings, claustrophobia, etc. 12. Subjects with history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year. 13. Subjects with current, past or anticipated exposure to radiation in the work place within one year of proposed research PET scans. 14. Subjects with history of IV drug use which would prevent venous access for PET tracer injection. 15. Blood donation within eight weeks of the start of the study 16. History of blooding disorder or currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto). |
Country | Name | City | State |
---|---|---|---|
United States | Yale University | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Change in [11C]PBR28 Distribution Volume After Alcohol Challenge. | This is the percent change in [11C]PBR28 distribution volume (V_T) post-alcohol relative to baseline.
This is calculated as [V_T(Post-Alcohol) - V_T(Baseline)]/V_T(Baseline) As a percent change, it could range from -10% to 200%. |
The post-alcohol imaging scan start will begin between one and fours hours after the oral alcohol challenge is completed. The total scan time for each imaging scan is 120 minutes long. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05414344 -
A Brief Intervention for Alcohol Users With Interpersonal Trauma
|
N/A | |
Completed |
NCT05521906 -
Evaluation of PRYSHM for LGBTQIA2S+ Youth
|
N/A | |
Not yet recruiting |
NCT04786587 -
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
|
||
Withdrawn |
NCT04659278 -
Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use
|
N/A | |
Not yet recruiting |
NCT03632408 -
Hangover and Residual Zopiclone Effect on Spatial Perception
|
Phase 1 | |
Completed |
NCT02718508 -
An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use
|
N/A | |
Active, not recruiting |
NCT02629679 -
Sports, Education and Consumption of Substances in Adolescents
|
N/A | |
Completed |
NCT02945371 -
Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life
|
N/A | |
Completed |
NCT01553136 -
Varenicline Treatment of Alcohol Dependence in Smokers
|
Phase 2 | |
Completed |
NCT01442753 -
Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth
|
N/A | |
Completed |
NCT01081119 -
Brief Voluntary Alcohol and Drug Intervention for Middle School Youth
|
Phase 2 | |
Completed |
NCT04510116 -
Adults In The Making Prevention Trial
|
N/A | |
Completed |
NCT00289965 -
Substance Use Risk Education (SURE) Project
|
Phase 2 | |
Completed |
NCT00506753 -
Motivation and Skills for Delta-9-tetrahydrocannabinol/Ethanol (THC/ETOH+) Teens in Jail
|
N/A | |
Recruiting |
NCT05288790 -
Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT
|
Phase 2 | |
Recruiting |
NCT05620849 -
Young Adult Education on Alcohol & Health
|
N/A | |
Recruiting |
NCT03588754 -
Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking?
|
Phase 2 | |
Recruiting |
NCT04054466 -
Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients in HAART
|
N/A | |
Recruiting |
NCT06074341 -
TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study
|
N/A | |
Terminated |
NCT04596267 -
Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers
|
Phase 1 |