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

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

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.

Study Overview

• Status: Completed
• Conditions: Stress Disorder; Alcohol Use Disorder; Anxiety Disorder/Anxiety State; Hypothalamic Pituitary Adrenal; Drinking to Cope

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota Fairview Riverside

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 1) inpatients receiving treatment for an alcohol use disorder 2) healthy controls recruited from the community.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
AUD only; AUD treatment inpatients without a co-occurring AnxD receiving AUD treatment as usual
AnxD+AUD-Cognitive Behavioral Therapy (CBT); AUD treatment inpatients with a co-occurring anxiety disorder receiving AUD treatment as usual in addition to CBT for co-occurring AUD+AnxD
AnxD+AUD- No CBT; AUD treatment inpatients with a co-occurring anxiety disorder receiving AUD treatment as usual only.
Healthy Controls; Community sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Relapse Severity	Relapse severity will consist of the number days drinking during the 4 months following treatment discharge.	4-month follow-up

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Justin Anker, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2018
• Primary Completion (Actual): May 12, 2023
• Study Completion (Actual): May 12, 2023

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Disease; Anxiety Disorders
• Other Study ID Numbers: PSYCH-2017-23713; 1K01AA024805 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No