Chemically-Induced DisordersNCT02564991
Study of Structural Imaging
An observational study of Chemically-Induced Disorders and Substance-Related Disorders, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
Background: The way alcohol affects brain structure has been widely studied. But the way it affects all parts of the brain is still unknown. Researchers want to use magnetic resonance imaging (MRI) scans to study brain structure and function. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Chemically-Induced Disorders, Substance-Related Disorders, Mental Disorders
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Feb 2016to 18 Mar 2020
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Healthy volunteers and Inpatient participants with alcohol use disorders. . Design Participants will receive whole-brain structural imaging and assessment of cerebellar function at the time of admission and again at the time of discharge
Who may be able to join
- 30 to 60 years old
- Physically healthy
- Healthy volunteers only: Currently consuming 7 or less standard drinks per week if female; 14 or less drinks per week if male.
Who cannot join
- Significant history of head trauma or cranial surgery,
- History of diabetes or stroke which requires medical intervention,
- Clinical or laboratory evidence of severe hepatic disease as determined by ALT or AST greater than 5 times the upper normal limit, INR greater than 2.0, total bilirubin greater than 2.5 mg/dL, and albumin lower than 3.0 g/dL.
- Positive HIV test.
- Healthy volunteers only: 5 or more binge drinking episodes in the past 30 days (5 or more standard drinks on one occasion for males, 4 or more standard drinks on one occasion for females within two hours)
- Healthy volunteers only:
Show all 11Show fewer
- --Have fulfilled DSM-IV or DSM-5 criteria for current alcohol use disorder or substance abuse disorder
- Inpatient participants only: Currently experiencing symptoms of withdrawal from alcohol (As determined by the most recent measurement within the past 30 days CIWA score > 8)
- Female participants only: Are currently pregnant
- IPresence of any contraindication for fMRI as determined by the NIAAA MRI Safety Screening Questionnaire
- Have calustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Cross-Sectional and Longitudinal Study of Structural Imaging
Background:
The way alcohol affects brain structure has been widely studied. But the way it affects all parts of the brain is still unknown. Researchers want to use magnetic resonance imaging (MRI) scans to study brain structure and function. They hope this will help them better understand changes that happen in brain regions during treatment of alcohol use disorders.
Read more
Objectives:
To study changes in the brain by using MRI in people with and without alcohol use disorders. To study how brain changes affect gait, balance, cognitive ability, and behavior. To see how the brain recovers when alcohol use stops.
Eligibility:
People with alcohol dependence who are currently hospitalized in a particular unit at NIH.
Healthy volunteers 30 60 years old without an alcohol use disorder.
Design:
Participants will be screened under a separate protocol.
Participants will give a urine sample for a drug test and pregnancy test at each study visit. They will also have to pass a breath alcohol test.
At the first visit, participants will have an MRI. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder.
They will do behavior and memory tasks outside the scanner.
They will have gait and balance tested. They will have to stand on both legs, stand on just one leg, and walk in a straight line. They will perform each task with eyes open, then with eyes closed.
They will have tests of memory, thinking, and problem solving.
Some participants will have a second visit. They will have another MRI and repeat some of the behavior and memory tasks.
...
Read the detailed description
Objective
The purpose of this protocol is to characterize cerebellar volumes and function in alcoholics and recovery of cerebellar volume and function during early abstinence. This study also investigates how cerebrocerebellar circuits contribute to cognitive and motor impairment in alcoholism.
Study Population
Healthy volunteers and Inpatient participants with alcohol use disorders.
Design
Participants will receive whole-brain structural imaging and assessment of cerebellar function at the time of admission and again at the time of discharge.
Outcome
The Primary outcome of this study is to assess recovery of cerebellar structure and function at the end of treatment compared to treatment entry measures.
- Conditions
- Chemically-Induced Disorders, Substance-Related Disorders, Mental Disorders, Alcohol Dependence, Alcohol-Related Disorders
- Keywords
- Alcoholism, MRI, Structural MRI, Cerebellum, Natural History
- Medical subject headings
- Chemically-Induced Disorders, Substance-Related Disorders, Mental Disorders, Alcoholism, Alcohol-Related Disorders
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 |
|---|---|---|
| Healthy Controls | 125 non-substance abusing controls (NSAC) | |
| Individuals with Alcohol Use Disorder | This group includes individuals who enrolled NIAAA alcohol treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary outcome of this study is to assess recovery of cerebellar structure and function at the end of treatment compared to treatment entry measures.
To assess recovery of cerebellar structure and function at the end oftreatment compared to treatment entry measures.
Measured: Entry and End of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study start29 Feb 2016
- Primary completion18 Mar 2020
- Study completion18 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemically-Induced DisordersStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Reza Momenan, Ph.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564991
- Sponsor's protocol ID
- 150203
- Other IDs
- 15-AA-0203
- Status last verified
- May 2024
- First submitted
- 30 Sep 2015
- Last updated
- 6 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Sectional and Longitudinal Study of Structural Imaging
- ClinicalTrials.gov ID
- NCT02564991
- Acronym / sponsor ID
- 150203
- Conditions
- Chemically-Induced Disorders, Substance-Related Disorders, Mental Disorders, Alcohol Dependence, Alcohol-Related Disorders
- Keywords
- Alcoholism, MRI, Structural MRI, Cerebellum, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 1 Oct 2015 (estimated)
- 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.
Background:
The way alcohol affects brain structure has been widely studied. But the way it affects all parts of the brain is still unknown. Researchers want to use magnetic resonance imaging (MRI) scans to study brain structure and function. They hope this will help them better understand changes that happen in brain regions during treatment of alcohol use disorders.
Objectives:
To study changes in the brain by using MRI in people with and without alcohol use disorders. To study how brain changes affect gait, balance, cognitive ability, and behavior. To see how the brain recovers when alcohol use stops.
Eligibility:
People with alcohol dependence who are currently hospitalized in a particular unit at NIH.
Healthy volunteers 30 60 years old without an alcohol use disorder.
Design:
Participants will be screened under a separate protocol.
Participants will give a urine sample for a drug test and pregnancy test at each study visit. They will also have to pass a breath alcohol test.
At the first visit, participants will have an MRI. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder.
They will do behavior and memory tasks outside the scanner.
They will have gait and balance tested. They will have to stand on both legs, stand on just one leg, and walk in a straight line. They will perform each task with eyes open, then with eyes closed.
They will have tests of memory, thinking, and problem solving.
Some participants will have a second visit. They will have another MRI and repeat some of the behavior and memory tasks.
...
Detailed description
Objective
The purpose of this protocol is to characterize cerebellar volumes and function in alcoholics and recovery of cerebellar volume and function during early abstinence. This study also investigates how cerebrocerebellar circuits contribute to cognitive and motor impairment in alcoholism.
Study Population
Healthy volunteers and Inpatient participants with alcohol use disorders.
Design
Participants will receive whole-brain structural imaging and assessment of cerebellar function at the time of admission and again at the time of discharge.
Outcome
The Primary outcome of this study is to assess recovery of cerebellar structure and function at the end of treatment compared to treatment entry measures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | –125 non-substance abusing controls (NSAC) |
| Individuals with Alcohol Use Disorder | – | –This group includes individuals who enrolled NIAAA alcohol treatment. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Healthy volunteers and Inpatient participants with alcohol use disorders. . Design Participants will receive whole-brain structural imaging and assessment of cerebellar function at the time of admission and again at the time of discharge
Key inclusion criteria (3 listed)
Key exclusion criteria (11 listed)
- Significant history of head trauma or cranial surgery,
- History of diabetes or stroke which requires medical intervention,
- Clinical or laboratory evidence of severe hepatic disease as determined by ALT or AST greater than 5 times the upper normal limit, INR greater than 2.0, total bilirubin greater than 2.5 mg/dL, and albumin lower than 3.0 g/dL.
- Positive HIV test.
- Healthy volunteers only: 5 or more binge drinking episodes in the past 30 days (5 or more standard drinks on one occasion for males, 4 or more standard drinks on one occasion for females within two hours)
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
The Primary outcome of this study is to assess recovery of cerebellar structure and function at the end of treatment compared to treatment entry measures.
Time frame: Entry and End of Treatment
To assess recovery of cerebellar structure and function at the end oftreatment compared to treatment entry measures.
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 6 May 2024.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Reza Momenan, Ph.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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 Chemically-Induced Disorders and Substance-Related Disorders, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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 3 inclusion and 11 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 6 May 2024. 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?
The Primary outcome of this study is to assess recovery of cerebellar structure and function at the end of treatment compared to treatment entry measures. (time frame: Entry and End of Treatment). 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 6 May 2024.