A Response Modulation Hypothesis of Socioemotional Processing Associated With Alcohol Use Disorder
Healthy Volunteers · Alcohol Drinking Related Problems · Alcohol-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03535129 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Real time fMRI neurofeedback (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- National Institutes of Health Clinical Center (CC)
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alcohol Attention Bias Signal - Stage 1 |
0.007121461; 0.135970228; -0.015216812; 0.112620872; 0.006437261; -0.011383586 | — |
| PRIMARY Change in Alcohol Craving - Stage 1 |
0.02; 0.12 | — |
| PRIMARY Change in Alcohol Attention Bias - Stage 2 |
-0.231955025; 0.184816519; 0.575760441; -0.009628402; 0.420713313; 0.288568992 | — |
| PRIMARY Change in Alcohol Craving - Stage 2 |
-0.35; -0.50; -0.03; -0.04 | — |
| PRIMARY Mean Alcohol Craving Score |
3.12; 2.42; 3.69; 3.60; 2.94; 3.11 | — |
Summary
Eligibility Criteria
- INCLUSION AND EXCLUSION CRITERIA:
Stage 1:
INCLUSION CRITERIA
- 21 to 65 years old
- 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)
- Alcohol use disorder (AUD) participants only: Diagnosed with current moderate to severe alcohol use disorder according to most recent Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (SCID-5) diagnosis
EXCLUSION CRITERIA
- Significant history of head trauma or cranial surgery.
- 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 neuro-abnormalities that, in the PI or MAI's expert opinion, interfere with research neuroimaging data, the subject may be excluded from data analysis.
- Physical health concern that would significantly impair or increase the risk of study participation
- Healthy volunteers only: Have fulfilled the DSM-5 criteria for a current substance or alcohol use disorder
- Female participants only: Currently pregnant
- 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
- Any flag on the NIAAA MRI Safety Screening Questionnaire, unless cleared by medically responsible staff (MD/NP)
- History of non-substance related psychosis
- Lack of experience with alcohol (defined as less than three lifetime drinks reported in history and physical or on Lifetime Drinking History)
Stage 2:
INCLUSION CRITERIA
- 21 to 65 years old
- Inpatient currently seeking treatment for alcohol use disorder
EXCLUSION CRITERIA
- Significant history of head trauma or cranial surgery,
- History of neurological disease based on self-report and neuromotor physical exam, conducted by a health care provider, that would interfere with neuroimaging research.
- Physical health concern that would significantly impair or increase the risk of study participation.
- 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
- Any flag on the NIAAA MRI Safety Screening Questionnaire, unless cleared by medically responsible staff (MD/NP)
- History of non-substance related psychosis
- 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/e
Data sourced from ClinicalTrials.gov (NCT03535129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.