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

NCT ID: NCT03056872

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-05
• Study Completion Date: 2023-05-12

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

AUD only

AUD treatment inpatients without a co-occurring AnxD receiving AUD treatment as usual

No interventions assigned to this group

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

No interventions assigned to this group

AnxD+AUD- No CBT

AUD treatment inpatients with a co-occurring anxiety disorder receiving AUD treatment as usual only.

No interventions assigned to this group

Healthy Controls

Community sample

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Justin Anker, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota Fairview Riverside

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1K01AA024805

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PSYCH-2017-23713

Identifier Type: -

Identifier Source: org_study_id