Stress Reactivity as a Determinant in Co-occurring Alcohol Use and Anxiety Disorder: Diagnosis and Alcohol Use Outcomes

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056872
• Other study ID #: PSYCH-2017-23713
• Secondary ID: 1K01AA024805
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Anxiety Disorder/Anxiety State
• Anxiety Disorders
• Disease
• Drinking to Cope
• Hypothalamic Pituitary Adrenal
• Stress Disorder

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