Alcohol DependencePhase 1NCT03010917
Fish Oil vs. Placebo on Subjective Effects of Alcohol
A Phase 1 study of Alcohol Dependence, run by Yale University at 1 site in United States.
Trial summary
This project represents a first step in examining the potential use of fish oil for the treatment of alcohol use disorder (AUD). The investigators will be testing for attenuation of alcohol-induced sedative and stimulant effects, as well as cognitive effects and cerebellar effects in healthy social drinkers. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Dependence
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2017to 8 Sep 2021
- Phase
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and females, between the ages of 21 and 55;
- No current drug use disorder of any drugs of abuse (except tobacco or marijuana);
- No current medical problems and normal ECG;
- For women, not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods.
Who cannot join
- Current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
- History of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study;
- Liver function tests (ALT or AST) greater than 3 times normal;
- Allergy to seafood.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healtcare System
West Haven, Connecticut, 06516
About this study
Official title: Effect of Fish Oil vs. Placebo on Subjective Effects of Alcohol in Healthy Humans
This project represents a first step in examining the potential use of fish oil for the treatment of alcohol use disorder (AUD). The investigators will be testing for attenuation of alcohol-induced sedative and stimulant effects, as well as cognitive effects and cerebellar effects in healthy social drinkers.
Read the detailed description
There have been no studies to date that have examined the relationship between fish oil and alcohol response in humans. The current study was designed to examine the relationship between fish oil and subjective alcohol effects in healthy social drinkers.
This project represents a first step in examining the potential use of fish oil for the treatment of alcohol use disorder (AUD). The investigators will evaluate responses to alcohol through administration of a steady state blood alcohol level (BAL) with an IV infusion using a method that employs an infusion that is titrated to a breathalyzer reading and clamped at a steady state. This approach allows direct comparisons of the acute effects of a specific dose of ethanol between groups, without the confounding factors of variable alcohol absorption and peak BAL's. This approach will allow the examiners to carefully examine if fish oil changes the acute effects of alcohol on a number of outcome domains including subjective drug effects, cognitive performance, and cerebellar effects.
As this study is a pilot study, it is not clear whether fish oil will attenuate alcohol induced subjective stimulation or sedation. Since this is the first study to evaluate fish oil's effects on alcohol-effects in the laboratory, the investigators will be testing for attenuation of alcohol-induced sedative and stimulant effects, as well as cognitive effects and cerebellar effects.
In this study, fish oil will be administered at 3 grams/day for 30-40 days (3 capsules twice a day). The investigators will use 3 grams/day for two reasons: 1) it is within the range of doses safely used in humans (1g to 6g) as a treatment for various psychiatric conditions (depression, anxiety, borderline personality disorder), and 2) is a dose that has shown efficacy in various clinical trials for psychiatric conditions.
- Conditions
- Alcohol Dependence
- Being tested
- Fish Oil with ethanol and placebo ethanol infusions, Placebo with ethanol and placebo ethanol infusions
- Keywords
- Alcohol Dependence, Fish Oil
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish Oil with ethanol and placebo ethanol infusionsDrug
Fish Oil with ethanol and placebo ethanol infusions
Placebo with ethanol and placebo ethanol infusionsDrug
Placebo with ethanol and placebo ethanol infusions
| Study group | Role | What they receive |
|---|---|---|
| Fish Oil with ethanol and placebo ethanol infusions | Experimental | Between days 30-40 subjects will participate in 2 test days at least 2 days apart and during the test day will receive an IV infusion of ethanol (placebo vs. targeted Breath Alcohol Concentration ((BrAC) of 100mg%) in a clamped fashion. Test days will be in a randomized order. Receives: Drug: Fish Oil with ethanol and placebo ethanol infusions |
| Placebo with ethanol and placebo ethanol infusions | Placebo comparator | Between days 30-40 subjects will participate in 2 test days at least 2 days apart and during the test day will receive an IV infusion of ethanol (placebo vs. targeted Breath Alcohol Concentration ((BrAC) of 100mg%) in a clamped fashion. Test days will be in a randomized order. Receives: Drug: Placebo with ethanol and placebo ethanol infusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of stimulant and sedative effects of alcohol with the Biphasic Alcohol Effects Scale (BAES).
The BAES is a 14-item self-report scale. Seven items measure stimulant effects of alcohol during the test sessions and seven items measure sedative effects. Stimulant and sedative effect scores range from 0 (not at all) to 70 (extremely).
Measured: Baseline
Assessment of stimulant and sedative effects of alcohol with the Biphasic Alcohol Effects Scale (BAES).
Measured: Week 4 (test session 1)
Assessment of stimulant and sedative effects of alcohol with the Biphasic Alcohol Effects Scale (BAES).
Measured: Week 6 (test session 2)
Secondary outcomes (12)
Cognitive performance measured with the Rapid Information Processing Task (RVIP)
(RVIP) is a widely used task to assess sustained attention, with a working memory component. In this task, a series of single digits is presented on a computer screen at a rate of 100 digits per minute for 4 min. Targets are defined as three consecutive odd digits (e.g., 7-9-3) or three consecutive even digits (e.g., 2-8-6). The percentage of targets correctly detected will be the main outcome measure.
Measured: Baseline
Cognitive performance measured with the Rapid Information Processing Task (RVIP)
(RVIP) is a widely used task to assess sustained attention, with a working memory component. In this task, a series of single digits is presented on a computer screen at a rate of 100 digits per minute for 4 min. Targets are defined as three consecutive odd digits (e.g., 7-9-3) or three consecutive even digits (e.g., 2-8-6). The percentage of targets correctly detected will be the main outcome measure.
Measured: Week 4 (test session 1)
Cognitive performance measured with the Rapid Information Processing Task (RVIP)
(RVIP) is a widely used task to assess sustained attention, with a working memory component. In this task, a series of single digits is presented on a computer screen at a rate of 100 digits per minute for 4 min. Targets are defined as three consecutive odd digits (e.g., 7-9-3) or three consecutive even digits (e.g., 2-8-6). The percentage of targets correctly detected will be the main outcome measure.
Measured: Week 6 (test session 2)
Cognitive performance measured by a "Go No-Go task" will assess the ability to withhold responses to an infrequently occurring target.
A series of blue and green rectangular shapes are presented every 1150 ms and participants are instructed to press a spacebar every time the green rectangular shape appeared, and to give equal importance to speed and accuracy. The primary outcome is the number of errors on the No-Go trials.
Measured: Baseline
Cognitive performance measured by a "Go No-Go task" will assess the ability to withhold responses to an infrequently occurring target.
A series of blue and green rectangular shapes are presented every 1150 ms and participants are instructed to press a spacebar every time the green rectangular shape appeared, and to give equal importance to speed and accuracy. The primary outcome is the number of errors on the No-Go trials.
Measured: Week 4 (test session 1)
Cognitive performance measured by a "Go No-Go task" will assess the ability to withhold responses to an infrequently occurring target.
A series of blue and green rectangular shapes are presented every 1150 ms and participants are instructed to press a spacebar every time the green rectangular shape appeared, and to give equal importance to speed and accuracy. The primary outcome is the number of errors on the No-Go trials.
Measured: Week 6 (test session 2)
Cognitive performance measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).
The HVLT-R is a word list learning test of verbal memory. The outcome is the percent correct on immediate and delayed recall of words on a list.
Measured: Baseline
Cognitive performance measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).
The HVLT-R is a word list learning test of verbal memory. The outcome is the percent correct on immediate and delayed recall of words on a list.
Measured: Week 4 (test session 1)
Cognitive performance measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).
The HVLT-R is a word list learning test of verbal memory. The outcome is the percent correct on immediate and delayed recall of words on a list.
Measured: Week 6 (test session 2)
Motor Impairment: The Grooved Pegboard Test (Lafayette Instrument Company) is a manipulative dexterity test,
This is an eye-to hand timed coordination test. A quicker time indicates greater coordination.
Measured: Baseline
Motor Impairment: The Grooved Pegboard Test (Lafayette Instrument Company) is a manipulative dexterity test,
This is an eye-to hand timed coordination test. A quicker time indicates greater coordination.
Measured: Week 4 (test session 1)
Motor Impairment: The Grooved Pegboard Test (Lafayette Instrument Company) is a manipulative dexterity test,
This is an eye-to hand timed coordination test. A quicker time indicates greater coordination.
Measured: Week 6 (test session 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start2 Mar 2017
- Primary completion30 May 2021
- Study completion8 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- VA Connecticut Healthcare System
- Responsible party
- Sponsor
- Investigators
- Ismene Petrakis, M.D., Principal investigator, Yale University/VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010917
- Sponsor's protocol ID
- 1609018478
- Status last verified
- Sep 2022
- First submitted
- 15 Dec 2016
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Subramanian MG, Heil SH, Kruger ML, Collins KL, Buck PO, Zawacki T, Abbey A, Sokol RJ, Diamond MP. A three-stage alcohol clamp procedure in human subjects. Alcohol Clin Exp Res. 2002 Oct;26(10):1479-83. doi: 10.1097/01.ALC.0000034038.41972.36.
PubMed 12394280Zimmermann US, O'Connor S, Ramchandani VA. Modeling alcohol self-administration in the human laboratory. Curr Top Behav Neurosci. 2013;13:315-53. doi: 10.1007/7854_2011_149.
PubMed 21792747Ramchandani VA, O'Connor S, Blekher T, Kareken D, Morzorati S, Nurnberger J Jr, Li TK. A preliminary study of acute responses to clamped alcohol concentration and family history of alcoholism. Alcohol Clin Exp Res. 1999 Aug;23(8):1320-30.
PubMed 10470974
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fish Oil vs. Placebo on Subjective Effects of Alcohol in Healthy Humans
- ClinicalTrials.gov ID
- NCT03010917
- Acronym / sponsor ID
- 1609018478
- Conditions
- Alcohol Dependence
- Keywords
- Alcohol Dependence, Fish Oil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- VA Connecticut Healthcare System
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 5 Jan 2017 (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.
This project represents a first step in examining the potential use of fish oil for the treatment of alcohol use disorder (AUD). The investigators will be testing for attenuation of alcohol-induced sedative and stimulant effects, as well as cognitive effects and cerebellar effects in healthy social drinkers.
Detailed description
There have been no studies to date that have examined the relationship between fish oil and alcohol response in humans. The current study was designed to examine the relationship between fish oil and subjective alcohol effects in healthy social drinkers.
This project represents a first step in examining the potential use of fish oil for the treatment of alcohol use disorder (AUD). The investigators will evaluate responses to alcohol through administration of a steady state blood alcohol level (BAL) with an IV infusion using a method that employs an infusion that is titrated to a breathalyzer reading and clamped at a steady state. This approach allows direct comparisons of the acute effects of a specific dose of ethanol between groups, without the confounding factors of variable alcohol absorption and peak BAL's. This approach will allow the examiners to carefully examine if fish oil changes the acute effects of alcohol on a number of outcome domains including subjective drug effects, cognitive performance, and cerebellar effects.
As this study is a pilot study, it is not clear whether fish oil will attenuate alcohol induced subjective stimulation or sedation. Since this is the first study to evaluate fish oil's effects on alcohol-effects in the laboratory, the investigators will be testing for attenuation of alcohol-induced sedative and stimulant effects, as well as cognitive effects and cerebellar effects.
In this study, fish oil will be administered at 3 grams/day for 30-40 days (3 capsules twice a day). The investigators will use 3 grams/day for two reasons: 1) it is within the range of doses safely used in humans (1g to 6g) as a treatment for various psychiatric conditions (depression, anxiety, borderline personality disorder), and 2) is a dose that has shown efficacy in various clinical trials for psychiatric conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish Oil with ethanol and placebo ethanol infusions | Experimental | Drug: Fish Oil with ethanol and placebo ethanol infusionsBetween days 30-40 subjects will participate in 2 test days at least 2 days apart and during the test day will receive an IV infusion of ethanol (placebo vs. targeted Breath Alcohol Concentration ((BrAC) of 100mg%) in a clamped fashion. Test days will be in a randomized order. |
| Placebo with ethanol and placebo ethanol infusions | Placebo comparator | Drug: Placebo with ethanol and placebo ethanol infusionsBetween days 30-40 subjects will participate in 2 test days at least 2 days apart and during the test day will receive an IV infusion of ethanol (placebo vs. targeted Breath Alcohol Concentration ((BrAC) of 100mg%) in a clamped fashion. Test days will be in a randomized order. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and females, between the ages of 21 and 55;
- No current drug use disorder of any drugs of abuse (except tobacco or marijuana);
- No current medical problems and normal ECG;
- For women, not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods.
Key exclusion criteria (4 listed)
- Current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
- History of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study;
- Liver function tests (ALT or AST) greater than 3 times normal;
- Allergy to seafood.
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 |
|---|---|---|
| Fish Oil with ethanol and placebo ethanol infusionsFish Oil with ethanol and placebo ethanol infusions | Drug | Fish Oil with ethanol and placebo ethanol infusions |
| Placebo with ethanol and placebo ethanol infusionsPlacebo with ethanol and placebo ethanol infusions | Drug | Placebo with ethanol and placebo ethanol infusions |
Primary outcome
Assessment of stimulant and sedative effects of alcohol with the Biphasic Alcohol Effects Scale (BAES).
Time frame: Baseline
The BAES is a 14-item self-report scale. Seven items measure stimulant effects of alcohol during the test sessions and seven items measure sedative effects. Stimulant and sedative effect scores range from 0 (not at all) to 70 (extremely).
Assessment of stimulant and sedative effects of alcohol with the Biphasic Alcohol Effects Scale (BAES).
Time frame: Week 4 (test session 1)
Assessment of stimulant and sedative effects of alcohol with the Biphasic Alcohol Effects Scale (BAES).
Time frame: Week 6 (test session 2)
12 secondary outcomes
Cognitive performance measured with the Rapid Information Processing Task (RVIP)
Time frame: Baseline
Cognitive performance measured with the Rapid Information Processing Task (RVIP)
Time frame: Week 4 (test session 1)
Cognitive performance measured with the Rapid Information Processing Task (RVIP)
Time frame: Week 6 (test session 2)
Cognitive performance measured by a "Go No-Go task" will assess the ability to withhold responses to an infrequently occurring target.
Time frame: Baseline
Cognitive performance measured by a "Go No-Go task" will assess the ability to withhold responses to an infrequently occurring target.
Time frame: Week 4 (test session 1)
Cognitive performance measured by a "Go No-Go task" will assess the ability to withhold responses to an infrequently occurring target.
Time frame: Week 6 (test session 2)
Cognitive performance measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).
Time frame: Baseline
Cognitive performance measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).
Time frame: Week 4 (test session 1)
Cognitive performance measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).
Time frame: Week 6 (test session 2)
Motor Impairment: The Grooved Pegboard Test (Lafayette Instrument Company) is a manipulative dexterity test,
Time frame: Baseline
Motor Impairment: The Grooved Pegboard Test (Lafayette Instrument Company) is a manipulative dexterity test,
Time frame: Week 4 (test session 1)
Motor Impairment: The Grooved Pegboard Test (Lafayette Instrument Company) is a manipulative dexterity test,
Time frame: Week 6 (test session 2)
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 22 Sep 2022.
- Background: PubMed 12394280Subramanian MG, Heil SH, Kruger ML, Collins KL, Buck PO, Zawacki T, Abbey A, Sokol RJ, Diamond MP. A three-stage alcohol clamp procedure in human subjects. Alcohol Clin Exp Res. 2002 Oct;26(10):1479-83. doi: 10.1097/01.ALC.0000034038.41972.36.
- Background: PubMed 21792747Zimmermann US, O'Connor S, Ramchandani VA. Modeling alcohol self-administration in the human laboratory. Curr Top Behav Neurosci. 2013;13:315-53. doi: 10.1007/7854_2011_149.
- Background: PubMed 10470974Ramchandani VA, O'Connor S, Blekher T, Kareken D, Morzorati S, Nurnberger J Jr, Li TK. A preliminary study of acute responses to clamped alcohol concentration and family history of alcoholism. Alcohol Clin Exp Res. 1999 Aug;23(8):1320-30.
- 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.
Ismene Petrakis, M.D. principal investigator
Yale University/VA Connecticut Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Alcohol Dependence, run by Yale 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 4 inclusion and 4 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 Sep 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Assessment of stimulant and sedative effects of alcohol with the Biphasic Alcohol Effects Scale (BAES). (time frame: Baseline). The study lists 3 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 NCT03010917, which also lists 3 linked publications.
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 Sep 2022.