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 : June 21, 2022
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|Condition or disease|
|Alcohol Use Disorder Anxiety Disorder/Anxiety State Stress Disorder Hypothalamic Pituitary Adrenal Drinking to Cope|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|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 :||February 12, 2023|
|Estimated Study Completion Date :||February 12, 2023|
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.
- 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.
- Relapse Severity [ Time Frame: 4-month follow-up ]Relapse severity will consist of the number days drinking during the 4 months following treatment discharge.
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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|
- 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
- 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)
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
|Contact: Justin J Anker, Ph.D.||firstname.lastname@example.org|
|Contact: Nikki Degeneffe, BSemail@example.com|
|United States, Minnesota|
|University of Minnesota Fairview Riverside||Recruiting|
|Minneapolis, Minnesota, United States, 55454|
|Contact: Nikki Degeneffe 612-625-7546 firstname.lastname@example.org|
|Principal Investigator:||Justin Anker, PhD||University of Minnesota|
|Responsible Party:||University of Minnesota|
|Other Study ID Numbers:||
1K01AA024805 ( U.S. NIH Grant/Contract )
|First Posted:||February 17, 2017 Key Record Dates|
|Last Update Posted:||June 21, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|