Alcohol Use DisorderNCT03056872
Stress Reactivity as a Determinant in Co-occurring Alcohol Use and Anxiety Disorder: Diagnosis and Alcohol Use Outcomes
An observational study of Alcohol Use Disorder and Anxiety Disorder/Anxiety State, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Anxiety Disorder/Anxiety State, Stress Disorder
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2018to 12 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of 1) inpatients receiving treatment for an alcohol use disorder 2) healthy controls recruited from the community.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Fairview Riverside
Minneapolis, Minnesota, 55454
About this study
Official title: Physiological 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.
Read the 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.
- Conditions
- Alcohol Use Disorder, Anxiety Disorder/Anxiety State, Stress Disorder, Hypothalamic Pituitary Adrenal, Drinking to Cope
- Medical subject headings
- Alcoholism, Anxiety Disorders, Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Status
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.
Measured: 4-month follow-up
Relapse Severity
Relapse severity will consist of the number days drinking during the 4 months following treatment discharge.
Measured: 4-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start5 Oct 2018
- Primary completion12 May 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Justin Anker, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056872
- Sponsor's protocol ID
- PSYCH-2017-23713
- Other IDs
- 1K01AA024805
- Status last verified
- May 2023
- First submitted
- 9 Feb 2017
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Stress Reactivity as a Determinant in Co-occurring Alcohol Use and Anxiety Disorder: Diagnosis and Alcohol Use Outcomes
- ClinicalTrials.gov ID
- NCT03056872
- Acronym / sponsor ID
- PSYCH-2017-23713
- Conditions
- Alcohol Use Disorder, Anxiety Disorder/Anxiety State, Stress Disorder, Hypothalamic Pituitary Adrenal, Drinking to Cope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 17 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 1) inpatients receiving treatment for an alcohol use disorder 2) healthy controls recruited from the community.
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Anker, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Use Disorder and Anxiety Disorder/Anxiety State, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse Status (time frame: 4-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.