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

Sponsor

University of Minnesota (Other)

Overall Status

Recruiting

CT.gov ID

NCT03056872

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

120

Enrollment

Location

52.3

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder Anxiety Disorder/Anxiety State Stress Disorder 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 Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 5, 2018

Anticipated Primary Completion Date :

Feb 12, 2023

Anticipated Study Completion Date :

Feb 12, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Relapse Status [4-month follow-up]
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.
Relapse Severity [4-month follow-up]
Relapse severity will consist of the number days drinking during the 4 months following treatment discharge.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota Fairview Riverside	Minneapolis	Minnesota	United States	55454

Sponsors and Collaborators

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

Investigators

Principal Investigator: Justin Anker, PhD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT03056872

Other Study ID Numbers:

PSYCH-2017-23713
1K01AA024805

First Posted:

Feb 17, 2017

Last Update Posted:

Jun 21, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2022