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

NCT03056872 | Completed

• 2 other identifiers: PSYCH-2017-237131K01AA024805
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder; Anxiety Disorder/Anxiety State; Stress Disorder; Hypothalamic Pituitary Adrenal; Drinking to Cope

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Minnesota Fairview Riverside

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Alcoholism; Anxiety Disorders; Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Trauma and Stressor Related Disorders

Study Officials

• Justin Anker, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 17, 2017
• Study Start: October 5, 2018
• Primary Completion: May 12, 2023
• Study Completion: May 12, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)