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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03056872
Other study ID # PSYCH-2017-23713
Secondary ID 1K01AA024805
Status Completed
Phase
First received
Last updated
Start date October 5, 2018
Est. completion date May 12, 2023

Study information

Verified date May 2023
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

The objectives of the proposed research are to 1) evaluate the effect of co-occurring AnxD on the severity of biological stress-mood system dysregulations in AUD inpatients at pre-treatment, 2) evaluate the effect of co-occurring AnxD on the persistence of stress-mood system dysregulations in AUD inpatients in the months following treatment, 3) evaluate the effects of treatment on biological stress-mood system re-regulation among AUD patients with co-occurring AnxD, and 4) evaluate the effect of re-regulation change in biological stress-mood system function on AUD clinical outcomes.


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
United States University of Minnesota Fairview Riverside Minneapolis Minnesota

Sponsors (2)

Lead Sponsor Collaborator
University of Minnesota National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

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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