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

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ClinicalTrials.gov Identifier: NCT03056872
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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
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.

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Study Type : Observational
Estimated 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 : October 5, 2018
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol Anxiety

Group/Cohort
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



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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 >10 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056872


Contacts
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Contact: Justin J Anker, Ph.D. 6122739805 stress-study@umn.edu
Contact: Nikki Degeneffe, BS 612-625-7546 stress-study@umn.edu

Locations
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United States, Minnesota
University of Minnesota Fairview Riverside Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Nikki Degeneffe    612-625-7546    stress-study@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Justin Anker, PhD University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03056872     History of Changes
Other Study ID Numbers: 1K01AA024805 ( U.S. NIH Grant/Contract )
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Alcoholism
Anxiety Disorders
Alcohol Drinking
Pathologic Processes
Mental Disorders
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs