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Alcohol Use DisorderEarly Phase 1NCT04412824

Multimodal Neuroimaging of Alcohol Cues, Cortisol Response, and Compulsive Motivation

A Early Phase 1 study testing Intravenous blood draw in people with Alcohol Use Disorder, run by Auburn University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study proposes to examine both the peripheral and central nervous system responses when light social drinkers and binge/heavy social drinkers are exposed to visual ethanol cues, followed by oral ethanol. Read more about this study

Who is it for?
Ages 21 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Intravenous blood draw
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
87 participants
Where
1 siteUnited States
Study dates
22 May 2020to 31 Dec 2021
Phase
Early Phase 1
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 21 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Binge/Heavy Social Drinkers (HSD): has never met DSM-IV criteria for alcohol or substance dependence; regular alcohol use over the past year of at least 10 drinks per week, including at lease one occasion per week consuming >4 drinks (males) or >3 drinks (females).
  • Able to read and write English.
  • Light Social Drinkers (LSD): has never met DSM-IV criteria for alcohol or substance dependence; regular alcohol use over the past year of 1-3 drinks per occasion, 1-3 times weekly, with no more than one occasion per month of drinking >4 drinks (male) or >3 drinks (females) (King et al., 2002).
  • Do not meet criteria for any Axis I DSM-IV psychiatric diagnoses except for individuals with a past diagnosis of Post-Traumatic Stress Disorder, Major Depressive Disorder, or Obsessive Compulsive Disorder
  • Provide negative urine toxicology screens during initial appointments and at admission for IV/fMRI sessions.
  • Body Mass Index between 20-35.
  • No current or former nicotine dependence.

Who cannot join

  • Meet current criteria for dependence on any psychoactive substance, excluding caffeine.
  • Current or past history of alcohol dependence or abuse.
  • Any current use of opiates or past history of opiate abuse/dependence.
  • Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse.
  • Any psychotic disorder or current psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders.
  • Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded.
  • Peri and post-menopausal women, and those with hysterectomies.
  • Pregnant and lactating women will be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Auburn University MRI Center

    Auburn, Alabama, 36832

Other trials in United States

About this study

This study proposes to examine both the peripheral and central nervous system responses when light social drinkers and binge/heavy social drinkers are exposed to visual ethanol cues, followed by oral ethanol. The findings will provide a greater understanding of the brain mechanisms (cerebral blood flow and functional connectivity) underlying the association between stress, cortisol release, alcohol craving, and alcohol stimulant and sedative effects. This knowledge could be significant in developing new therapies for the treatment of alcoholism.

Read the detailed description

Results from the 2014 National Survey on Drug Use and Health show that 26% of adults in the US engaged in binge drinking in the past month (SAMHSA 2014). Why some people "mature out" of this behavior while others persist may be due to one's physiological response to binge drinking. No previous study has assessed whether disrupted cortisol and neural network responses to alcohol cues may drive the compulsive alcohol consumption seen in binge drinking individuals who do not yet have an AUD.

The investigator will recruit beer drinking, non-smoking men and women ages 21-45 (N=80, equal gender) who are either moderate drinkers or binge/heavy drinkers for two neuroimaging and neuroendocrine assessments to determine if their "real world" drinking behavior, in a prospective one month follow up, can be predicted based upon the cortisol and neural network responses to alcohol cues (with a placebo control, counter-balanced and randomized). Finally, the influence of genetic variation in the FK506-binding protein 5 (FKBP5) gene, which regulates cortisol activity, on the cortisol and neural network responses to alcohol cues will be explored.

Being tested
Intravenous blood draw
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous blood drawDrug

    Also called Indwelling catheter for blood draws

    In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session

Study groups in NCT04412824
Study groupRoleWhat they receive
Alcohol Beverage CuesActive comparatorParticipants will complete an MRI with alcohol beverage visual cues and oral alcohol session.
Receives: Drug: Intravenous blood draw
Non-Alcoholic Beverage CuesPlacebo comparatorParticipants will complete an MRI with non-alcoholic beverage cues and oral alcohol session.
Receives: Drug: Intravenous blood draw

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Neural Blood Flow

    Blood flow is measured in ml/100 grams/minute. The interpretation is that blood flow to that area indicates that region of the brain is responding to the visual alcohol or non-alcoholic beverage cues. Change in blood flow will be calculated as the change (and slope) of measurements taken at 10, 20, 30 and 45 minutes during the procedure.

    Measured: During the Procedure: measurements taken at 10, 20, 30 and 45 minutes during the procedure.

  2. Change in Cortisol

    The units for cortisol are micrograms/deciliter and the interpretation is that amount has been released into the blood stream from the HPA axis in response to alcohol or alcohol cues. Change in Cortisol will be calculated by taking the change (and slopes) of measurements at 45, 30 and 5 minutes prior to procedure and comparing it to measurements taken at 65, 95, 110, 125 minutes following the procedure.

    Measured: Before Procedure to 125 minutes after the procedure.

  3. Drinking Behavior in daily experience outside of laboratory

    A smartphone app will be used to collect 4 surveys a day for 30 days after completion of both arms. Multilevel modeling will be used to analyze patterns of drinking over time.

    Measured: Day after Procedure to 30 days after procedure.

  4. Amount of Alcohol Consumed

    After exposure to alcoholic beverage and non-alcoholic beverage visual cues, quantity of alcohol consumed in a free choice test will be measured in milliliters.

    Measured: Immediately after the procedure.

Secondary outcomes (3)

  1. Changes in Alcohol Urges (AUQ)

    The urge to consume alcohol will be measured using the Alcohol Urge Questionnaire (AUQ). The AUQ consists of 8 questions 8-56 total point distribution. The greater the total points, the greater the measured urge to consume alcohol. The change in alcohol urge will be assessed with the taking the change (and slopes) of measurements at 45, 30 and 5 minutes prior to procedure and comparing it to measurements taken at 65, 95, 110, 125 minutes following the procedure.

    Measured: Before Procedure to 125 minutes after the procedure.

  2. Stress levels in daily experience outside of laboratory

    A smartphone app will be used to collect 4 surveys a day for 30 days after completion of both arms. Multilevel modeling will be used to analyze subjective experience of stress over time.

    Measured: Post follow-up procedure (30 days)

  3. Genetic Risk Factors (Single Nucleotide Polymorphisms; SNPs) Association with Cerebral Blood Flow, Craving, and Real world drinking and stress

    One sample of whole blood will be obtained and analyzed for genomic associations with other outcome measures.

    Measured: Post follow up procedure (within 2 years after procedure)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2020
  2. Study start22 May 2020
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04412824
Sponsor's protocol ID
19-263 MR 1907
Other IDs
R00AA025401
Status last verified
Mar 2022
First submitted
24 May 2020
Last updated
22 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: HIPAA requirements prohibit sharing of individual data. De-identified group data will be available.

Publications

  • Blaine SK, Ridner CM, Campbell BR, Crone L, Claus ED, Wilson JR, West SN, McClanahan AJ, Siddiq AS, Layman IMP, Macatee R, Ansell EB, Robinson JL, Beck DT. IL-6, but not TNF-alpha, response to alcohol cues and acute consumption associated with neural cue reactivity, craving, and future drinking in binge drinkers. Brain Behav Immun Health. 2023 Jun 11;31:100645. doi: 10.1016/j.bbih.2023.100645. eCollection 2023 Aug.

    PubMed 37484196

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Intravenous blood draw in people with Alcohol Use Disorder, run by Auburn University 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 7 inclusion and 8 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 22 Mar 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in Neural Blood Flow (time frame: During the Procedure: measurements taken at 10, 20, 30 and 45 minutes during the procedure.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04412824, which also lists 1 linked publication.

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 22 Mar 2022.

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