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Completed

NCT Number: NCT03056872

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota Fairview Riverside

Minneapolis, Minnesota, 55454, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Relapse Status

    Time frame: 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.

  2. Relapse Severity

    Time frame: 4-month follow-up

    Relapse severity will consist of the number days drinking during the 4 months following treatment discharge.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2017
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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