Understanding how brain activity affects alcohol use and social behavior
Investigating a Response Modulation Hypothesis of Socioemotional Processing Associated With Alcohol Use Disorder
This study is trying to see if people can learn to control their brain activity when faced with social situations and alcohol cues to help reduce cravings and improve their social skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT03535129 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between socioemotional processing and alcohol use disorder using functional magnetic resonance imaging (fMRI) and neurofeedback techniques. Participants, including healthy volunteers and those with alcohol use disorder, will undergo brain imaging while exposed to social and alcohol-related stimuli. The study aims to determine if individuals can control their brain activity in response to these cues and whether this control can help reduce alcohol cravings and improve social functioning. The research is designed to provide insights into the neural mechanisms underlying alcohol-related problems and to explore potential therapeutic interventions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 to 65 with a diagnosis of moderate to severe alcohol use disorder or healthy volunteers who consume alcohol within specified limits.
Not a fit: Patients with significant neurological issues or a history of head trauma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new neurofeedback-based treatments for individuals struggling with alcohol use disorder.
How similar studies have performed: While neurofeedback has been explored in various contexts, this specific approach to socioemotional processing in alcohol use disorder is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION AND EXCLUSION CRITERIA: Stage 1: INCLUSION CRITERIA: 1. 21 to 65 years old 2. Healthy volunteers only: Consuming on average 7 or less standard drinks/week if female; 14 or less standard drinks/week if male (as determined by the most recent measurement within the past 90 days Alcohol Timeline Followback) 3. AUD participants only: Diagnosed with current moderate to severe alcohol use disorder according to most recent SCID 5 diagnosis EXCLUSION CRITERIA: 1. Significant history of head trauma or cranial surgery 2. History of neurological disease based on self-report and neuromotor physical exam, conducted by a health care provider, that would interfere with neuroimaging research. Posthoc, clinical MRI scans done according to NIH Clinical Center policy may be reviewed and if there is evidence from that scan of past or current neuroabnormalities that, in the PI or MAI s expert opinion, interfere with research neuroimaging data, the subject may be excluded from data analysis. 3. Physical health concern that would significantly impair or increase the risk of study participation. 4. Healthy volunteers only: Have fulfilled DSM-5 criteria for a current substance or alcohol use disorder 5. Female participants only: Currently pregnant 6. Presence of any ferromagnetic objects in the body that may be aversively affected by or contraindicated for MRI as determined by the NIAAA MRI Safety Screening Questionnaire 7. Any flag on the NIAAA MRI Safety Screening Questionnaire, unless cleared by medically responsible staff (MD/NP) 8. History of non-substance related psychosis 9. Lack of experience with alcohol (defined as less than 3 lifetime drinks reported in history and physical or on Lifetime Drinking History) Stage 2: INCLUSION CRITERIA: 1. 21 to 65 years old 2. Inpatient currently seeking treatment for alcohol use disorder EXCLUSION CRITERIA: 1. Significant history of head trauma or cranial surgery, 2. History of neurological disease based on self-report and neuromotor physical exam, conducted by a health care provider, that would interfere with neuroimaging research. 3. Physical health concern that would significantly impair or increase the risk of study participation. 4. Presence of any ferromagnetic objects in the body that may be aversively affected by or contraindicated for MRI as determined by the NIAAA MRI Safety Screening Questionnaire 5. Any flag on the NIAAA MRI Safety Screening Questionnaire, unless cleared by medically responsible staff (MD/NP) 6. History of non-substance related psychosis 7. Female participants only: Currently pregnant Inpatients who have been admitted into the behavioral unit at the Clinical Center for AUD treatment, maybe considered for this study. Upon completion of consenting procedure, any data necessary (but not readily available) to determine eligibility maybe collected under this study. However, to avoid undue discomfort, burden, and inconvenience, this information, if available, can be gathered from routine clinical care or other NIAAA clinical studies and data up to 30 days prior to the consenting date. Participants who do not satisfy any of the above criteria will not participate in the study procedures at the time. They may be re-scheduled for a future date(s) when they fulfill all inclusion/exclusionary criteria. We will utilize SCID diagnoses (from other studies such as 14-AA-0181) to determine AUD diagnosis and any potential Axis I disorders. However, for inpatients, since the nursing practice is initially focused on patient detoxification and treatment, the SCID diagnoses might not always take place within the first week of the patient admission to the alcohol unit. This could seriously hamper the subject recruitment in the second stage of this study. We will conduct the MR scan of eligible participants (based on the above inclusion/exclusion criterion) according to study timeline regardless of the availability of SCID diagnoses. Inpatients are admitted based on the clinical opinion of medical staff that the individual has a pattern of alcohol use disorder. We will enroll inpatients with this opinion but the SCID diagnoses will be completed in order to have consistent research data on symptomology and severity, and to use any potential Axis I disorder as a study confound. Additionally, we will collect information on medications being taken by patients currently or within the last month, including dose, schedule, and timeline. This will be used as a covariate in the statistical design to control for variation associated with these medications.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Reza Momenan, Ph.D. — National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study coordinator: Beth A Lee, R.N.
- Email: beth.lee@nih.gov
- Phone: (301) 451-6964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.