Clinical trial NCT03056872: Stress Reactivity as a Determinant in Co-occurring Alcohol Use and Anxiety Disorder: Diagnosis and Alcohol Use Outcomes
Official title: Physiological Stress Reactivity as a Determinant in Co-occurring Alcohol Use and Anxiety Disorder: Diagnosis and Alcohol Use Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Use Disorder
Anxiety Disorder/Anxiety State
Stress Disorder
Hypothalamic Pituitary Adrenal
Drinking to Cope
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2017-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Relapse Status
timeFrame: 4-month follow-up
measure: Relapse Severity
timeFrame: 4-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Fairview Riverside
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Justin Anker, PhD
role: PRINCIPAL_INVESTIGATOR
References: