Alcohol AbuseNCT04543942

Sex Differences in Risk for Alcohol Abuse

A study testing Alcohol and Saline in people with Alcohol Abuse, run by Mark Fillmore at 1 site in United States.

Completed

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

Trial summary

This study will determine the neural and hormonal mechanisms underlying sex differences in sensitivity to the disinhibiting effects of alcohol in heavy drinkers. Read more about this study

Who is it for?: Ages 21 to 29 yearsHealthy volunteers can take part
Conditions the study is for: Alcohol Abuse
What is being tested?: Alcohol and Saline
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2019to 24 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 29 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

heavy drinking
Alcohol Use Disorder Identification Test score above 7
right-handed
BMI between 19 and 26
high school education
fluent in English
women must have regular menstrual cycles
not using hormonal contraceptives

Who cannot join

drug use disorder (SCID, DSM-5), other than nicotine or caffeine
meets withdrawal criteria
history of physical or psychiatric disease
contraindication for fMRI
pregnant or breastfeeding
smoking more than 5 cigarettes per day

Trial locations and contacts

1 site in 1 country.

United States1 site

University Of Kentucky Psychology Research Lab
Lexington, Kentucky, 40504

Other trials in United States

About this study

Official title: Neurobiological Factors Underlying Sex Differences in Risk for Alcohol Abuse

This study will determine the neural and hormonal mechanisms underlying sex differences in sensitivity to the disinhibiting effects of alcohol in heavy drinkers.

Read the detailed description

Alcohol abuse inflicts enormous physical, emotional, and financial burdens on the individual and society at large. Knowing who is at risk for alcohol abuse, and why, is crucial for the development of effective prevention and treatment strategies. Alcohol abuse has been traditionally considered a male-oriented problem and as a consequence research on risk factors specific to women has been minimal. However, the sex gap in substance abuse is closing rapidly, and findings from both animal and human studies suggest that females are actually more vulnerable to drug use than males. As such, there is an urgent need to identify sex differences in risk factors for alcohol abuse in order to develop sex-specific prevention and treatment efforts. One clear candidate risk factor is poor inhibitory control, both in terms of baseline levels of inhibition and sensitivity to the disinhibiting effects of alcohol. Recent studies suggest that sex hormones affect inhibitory control in drug-free individuals, potentially contributing to sex differences in baseline levels of inhibition. However, the degree to which fluctuations in sex hormones influence sex differences in inhibition-related brain function in sober and intoxicated individuals is not known. The proposed project will determine the neural and hormonal mechanisms underlying sex differences in sensitivity to the disinhibiting effects of alcohol in heavy drinkers.

The overall objective of the research is to identify hormonal determinants of alcohol effects on brain activation during response inhibition (BARI) in young adult female and male drinkers. BARI will be assessed using functional magnetic resonance imaging (fMRI) during performance of the stop signal task. This task reliably activates right-lateralized prefrontal regions implicated in inhibitory control. This study will assess BARI during IV alcohol (60mg%) and saline infusion in women during the early follicular and mid-luteal phases and in men at matched intervals.

Conditions: Alcohol Abuse
Being tested: Alcohol, Saline
Keywords: brain activation during response inhibition, BARI, fMRI, stop signal task, sex difference, menstrual, inhibitory control
Medical subject headings: Alcoholism

What participants receive

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

AlcoholDrug
Alcohol will be administered by IV infusion (60mg%).
SalineDrug
Saline is administered as the placebo

Study groups in NCT04543942
Study group	Role	What they receive
Alcohol, then saline, then alcohol, then saline	Experimental	Participants first received alcohol (60mg%) intravenously and then 24-48 hours later they received saline intravenously. Two weeks later, they again received alcohol (60mg%) intravenously and then 24 - 48 hours later they received saline intravenously. Receives: Drug: Alcohol; Drug: Saline
Saline, then alcohol, then saline, then alcohol	Experimental	Participants first received saline intravenously and then 24-48 hours later they received alcohol (60mg%) intravenously. Two weeks later, they again received saline intravenously and then 24 - 48 hours later they received alcohol (60mg%) intravenously. Receives: Drug: Alcohol; Drug: Saline

What is being measured

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

Brain Activation During Response Inhibition (BARI) - Alcohol Infusion
Brain activation during response inhibition (BARI) was assessed using blood oxygenation level dependent (BOLD) fMRI during performance of the stop signal task during alcohol (60mg%) infusion. Values were determined by the contrast of BOLD activation during successful inhibition trials relative to go trials.
Measured: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together
Brain Activation During Response Inhibition (BARI) - Saline Infusion
Brain activation during response inhibition (BARI) was assessed using blood oxygenation level dependent (BOLD) fMRI during performance of the stop signal task during saline infusion. Values were determined by the contrast of BOLD activation during successful inhibition trials relative to go trials.
Measured: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together

Secondary outcomes (14)

Estradiol Levels - Alcohol Infusion
Estradiol levels (pg/mL) were measured from blood samples following alcohol infusion.
Measured: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together
Estradiol Levels - Saline Infusion
Estradiol levels (pg/mL) were measured from blood samples following saline infusion.
Measured: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together
Progesterone Levels - Alcohol Infusion
Progesterone levels (ng/mL) were measured from blood samples prior to alcohol infusion.
Measured: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together
Progesterone Levels - Saline Infusion
Progesterone levels (ng/mL) were measured from blood samples following saline infusion.
Measured: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together
Testosterone Levels - Alcohol Infusion
Testosterone levels (ng/dL) were measured from blood samples following alcohol infusion.
Measured: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together
Testosterone Levels - Saline Infusion
Testosterone levels (ng/dL) were measured from blood samples following saline infusion.
Measured: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together
Biphasic Alcohol Effects Score - Stimulation - Alcohol Infusion
The Biphasic Alcohol Effects Scale (BAES) is a 14-point self-reporting, unipolar adjective rating scale designed to measure both stimulant and sedative effects of alcohol. Scores range from 0-10 for each of the 7 Stimulation sub-scale questions, for a total Stimulation score range of 0-70. Higher scores indicate increased stimulation. This outcome measure was collected during alcohol (60mg%) infusion.
Measured: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together
Biphasic Alcohol Effects Score - Sedation - Alcohol Infusion
The Biphasic Alcohol Effects Scale (BAES) is a 14-point self-reporting, unipolar adjective rating scale designed to measure both stimulant and sedative effects of alcohol. Scores range from 0-10 for each of the 7 Sedation sub-scale questions, for a total Sedation score range of 0-70. Higher scores indicate increased sedation. This outcome measure was collected during alcohol (60mg%) infusion.
Measured: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together
Biphasic Alcohol Effects Scale (BAES) - Stimulation - Saline Infusion
The Biphasic Alcohol Effects Scale (BAES) is a 14-point self-reporting, unipolar adjective rating scale designed to measure both stimulant and sedative effects of alcohol. Scores range from 0-10 for each of the 7 Stimulation sub-scale questions, for a total Stimulation score range of 0-70. Higher scores indicate increased stimulation. This outcome measure was collected during saline infusion.
Measured: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together
Biphasic Alcohol Effects Scale (BAES) - Sedation - Saline
The Biphasic Alcohol Effects Scale (BAES) is a 14-point self-reporting, unipolar adjective rating scale designed to measure both stimulant and sedative effects of alcohol. Scores range from 0-10 for each of the 7 Sedation sub-scale questions, for a total Sedation score range of 0-70. Higher scores indicate increased stimulation. This outcome measure was collected during saline infusion.
Measured: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together
Drug Effects Questionnaire Score - Feel - Alcohol Infusion
The Drug Effects Questionnaire (DEQ) consists of four questions to assess acute subjective response to alcohol intake. This measure captures the amount someone feels the effects of alcohol, on a scale from 0 to 100. Higher scores indicate greater levels of 'feel alcohol'. Scores were obtained during alcohol (60mg%) infusion.
Measured: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together
Drug Effects Questionnaire Score - Like - Alcohol Infusion
The Drug Effects Questionnaire (DEQ) consists of four questions to assess acute subjective response to alcohol intake. This measure captures the amount someone likes the effects of alcohol, on a scale from 0 to 100. Higher scores indicate greater levels of 'like alcohol'. Scores were obtained during alcohol (60mg%) infusion.
Measured: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together
Drug Effects Questionnaire (DEQ) - Feel - Saline Infusion
The Drug Effects Questionnaire (DEQ) consists of four questions to assess acute subjective response to alcohol intake. This measure captures the amount someone feels the effects of alcohol, on a scale from 0 to 100. Higher scores indicate greater levels of 'feel alcohol'. Scores were obtained during saline infusion.
Measured: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together
Drug Effects Questionnaire (DEQ) - Like - Saline Infusion
The Drug Effects Questionnaire (DEQ) consists of four questions to assess acute subjective response to alcohol intake. This measure captures the amount someone likes the effects of alcohol, on a scale from 0 to 100. Higher scores indicate greater levels of 'like alcohol'. Scores were obtained during saline infusion.
Measured: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together

Timeline

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

1 Nov 201924 May 2023

First posted10 Sep 2020
Study start1 Nov 2019
Primary completion24 May 2023
Study completion24 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alcohol AbuseStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04543942
Sponsor's protocol ID: 50301
Other IDs: K01AA024519-06
Status last verified: Aug 2024
First submitted: 2 Sep 2020
Last updated: 4 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
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 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neurobiological Factors Underlying Sex Differences in Risk for Alcohol Abuse
ClinicalTrials.gov ID: NCT04543942
Acronym / sponsor ID: 50301
Conditions: Alcohol Abuse
Keywords: brain activation during response inhibition, BARI, fMRI, stop signal task, sex difference, menstrual, inhibitory control
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Mark FillmoreUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: 1 Nov 2019 (actual)
Primary completion: 24 May 2023 (actual)
Study completion: 24 May 2023 (actual)
First posted: 10 Sep 2020 (actual)
Results: Posted 4 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will determine the neural and hormonal mechanisms underlying sex differences in sensitivity to the disinhibiting effects of alcohol in heavy drinkers.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Alcohol, then saline, then alcohol, then saline	Experimental	Drug: Alcohol, Drug: SalineParticipants first received alcohol (60mg%) intravenously and then 24-48 hours later they received saline intravenously. Two weeks later, they again received alcohol (60mg%) intravenously and then 24 - 48 hours later they received saline intravenously.
Saline, then alcohol, then saline, then alcohol	Experimental	Drug: Alcohol, Drug: SalineParticipants first received saline intravenously and then 24-48 hours later they received alcohol (60mg%) intravenously. Two weeks later, they again received saline intravenously and then 24 - 48 hours later they received alcohol (60mg%) intravenously.

Who may qualify

Ages: 21 to 29 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

heavy drinking
Alcohol Use Disorder Identification Test score above 7
right-handed
BMI between 19 and 26
high school education

Key exclusion criteria (6 listed)

drug use disorder (SCID, DSM-5), other than nicotine or caffeine
meets withdrawal criteria
history of physical or psychiatric disease
contraindication for fMRI
pregnant or breastfeeding

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AlcoholAlcohol will be administered by IV infusion (60mg%).	Drug	Alcohol, then saline, then alcohol, then saline, Saline, then alcohol, then saline, then alcohol
SalineSaline is administered as the placebo	Drug	Alcohol, then saline, then alcohol, then saline, Saline, then alcohol, then saline, then alcohol

Primary outcome

Brain Activation During Response Inhibition (BARI) - Alcohol Infusion
Time frame: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together
Brain activation during response inhibition (BARI) was assessed using blood oxygenation level dependent (BOLD) fMRI during performance of the stop signal task during alcohol (60mg%) infusion. Values were determined by the contrast of BOLD activation during successful inhibition trials relative to go trials.
Brain Activation During Response Inhibition (BARI) - Saline Infusion
Time frame: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together
Brain activation during response inhibition (BARI) was assessed using blood oxygenation level dependent (BOLD) fMRI during performance of the stop signal task during saline infusion. Values were determined by the contrast of BOLD activation during successful inhibition trials relative to go trials.

14 secondary outcomes

Estradiol Levels - Alcohol Infusion
Time frame: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together
Estradiol Levels - Saline Infusion
Time frame: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together
Progesterone Levels - Alcohol Infusion
Time frame: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together
Progesterone Levels - Saline Infusion
Time frame: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together
Testosterone Levels - Alcohol Infusion
Time frame: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together
Testosterone Levels - Saline Infusion
Time frame: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together
Biphasic Alcohol Effects Score - Stimulation - Alcohol Infusion
Time frame: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together
Biphasic Alcohol Effects Score - Sedation - Alcohol Infusion
Time frame: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together
Biphasic Alcohol Effects Scale (BAES) - Stimulation - Saline Infusion
Time frame: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together
Biphasic Alcohol Effects Scale (BAES) - Sedation - Saline
Time frame: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together
Drug Effects Questionnaire Score - Feel - Alcohol Infusion
Time frame: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together
Drug Effects Questionnaire Score - Like - Alcohol Infusion
Time frame: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together
Drug Effects Questionnaire (DEQ) - Feel - Saline Infusion
Time frame: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together
Drug Effects Questionnaire (DEQ) - Like - Saline Infusion
Time frame: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together

Results and safety

Results posted to the registry on 4 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Alcohol, Then Saline, Then Alcohol, Then Saline	13	11
Saline, Then Alcohol, Then Saline, Then Alcohol	15	13

Primary outcome: Brain Activation During Response Inhibition (BARI) - Alcohol Infusion

Time frame: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together. Mean (Standard Deviation). Unit: BOLD activation

Measure	Males n = 9	Females n = 13
Value	1.83 (1.11)	2.41 (1.35)

Primary outcome: Brain Activation During Response Inhibition (BARI) - Saline Infusion

Time frame: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together. Mean (Standard Deviation). Unit: BOLD activation

Measure	Males n = 9	Females n = 13
Value	1.32 (1.44)	2.64 (1.90)

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected at each of the four study visits over approximately 4 weeks of study participation.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Males	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Females	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Alcohol Abuse

Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Not yet recruiting
The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans
Alcohol Problems, Post-Traumatic Stress Disorder
Not yet recruiting
A Hybrid Type 1 Randomized Controlled Trial of an Online and Text-Messaging Intervention to Prevent Alcohol and Cannabis Initiation, Escalation, and Consequences Among First-Year College Students
Alcohol, Cannabis
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism

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.

Mark Fillmore, Ph.D. principal investigator

University of Kentucky

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Alcohol and Saline in people with Alcohol Abuse, run by Mark Fillmore 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 8 inclusion and 6 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 4 Sep 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?

Yes. Results are posted in the registry (first posted 4 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Brain Activation During Response Inhibition (BARI) - Alcohol Infusion (time frame: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together). 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?

On the ClinicalTrials.gov record for NCT04543942.

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 4 Sep 2024.