Alcohol Use Disorder Clinical Trial
Official title:
Physiological Stress Reactivity as a Determinant in Co-occurring Alcohol Use and Anxiety Disorder: Diagnosis and Alcohol Use Outcomes
Verified date | May 2023 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Alcohol dependence is among the most common and costly public health problems affecting the nation. Among individuals with alcohol use disorder (AUD), those with (vs. without) a co-occurring anxiety disorder (AnxD) are as much as twice as likely to relapse in the months following AUD treatment. Dysregulation of biological stress-mood systems predict and correlate with AUD relapse and AnxD symptomatology. In contrast, stress system re-regulation correlates with improved AUD treatment outcomes but has not been examined with respect to AUD recovery and relapse in co-occurring AUD+AnxD.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 12, 2023 |
Est. primary completion date | May 12, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Ability to provide informed consent - Between the ages of 18 and 65 - Diagnostic and Statistical Manual diagnosis of a Panic Disorder, Generalized Anxiety Disorder, or Social Anxiety Disorder within the past 30 days (AUD+AnxD group only). - Primary alcohol use disorder diagnosis and alcohol use in the 30 days preceding the study (AUD alone and AUD+AnxD groups only). - Inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug with nicotine accepted) dependence (AUD alone and AUD+AnxD groups only). - A minimum of a sixth-grade reading level. - Healthy controls, same criteria absent AUD and AnxD diagnosis of an alcohol and/or anxiety disorder - Lives within proximity to the Twin Cities (e.g., within about an hour's drive) or willing to drive to Fairview for the purpose of attending follow-up visits - Willingness to provide contact information to confirm follow-up appointments Exclusion Criteria: - Lifetime history of psychosis or mania - Cognitive impairment, physical impairment, or chronic medical illness that precludes study participation - Primary PTSD as determined by qualifying assessment - Females currently pregnant - Exposure to antipsychotic medication for a total duration >16 weeks. - Prior head injury leading to >30 minutes of unconsciousness. - Cognitive impairment that impedes study participation. - Healthy controls with a history of any major medical or psychiatric disorders (e.g., schizophrenia, depression, heart disease, or stroke). - Suicide intent or attempt in the past 30 days - Cardiovascular health issues - Thyroid Disease - History of severe neurological illness such as chronic seizure disorder (e.g, epilepsy) or stroke - Brain tumor and/or implants in the skull cavity (e.g., plate in the skull) - Pacemaker |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota Fairview Riverside | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relapse Status | Relapse status will be assessed using a categorical measure of whether someone did vs did not drink (yes vs. no) during the 4 months following treatment discharge. | 4-month follow-up | |
Primary | Relapse Severity | Relapse severity will consist of the number days drinking during the 4 months following treatment discharge. | 4-month follow-up |
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