AlcoholismNCT00612352

Intravenous Alcohol Administration Using BrAc Method in Healthy Subjects With and Without a Family History of Alcoholism

A study of Alcoholism, run by Yale 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.

Trial summary

The proposed study is the first to explore the contribution of brain glutamate systems, a major target of ethanol in the brain, to the vulnerability to develop alcoholism. This study may lead to an enhanced understanding of the underlying neurobiological mechanism in high risk individuals that may lead to the… Read more about this study

Who is it for?: Ages 21 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Alcoholism
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 siteUnited States
Study dates: Mar 2001to Jun 2015
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 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male and female between the ages of 21 and 30 years;
medically and neurologically healthy on the basis of history, physical examination, EKG, Screening laboratories absence of current and/or past substance abuse on the basis of history and urine toxicology and breath alcohol levels at screening and on each test day.
For Family History Positive (FHP) Subjects: 1) Biological father and another first or second-degree biological relative with history of alcoholism by Family History Assessment Module (FHAM) developed by COGA.

Who cannot join

DSM-IV psychiatric and substance abuse (excluding alcohol abuse) diagnosis by history on psychiatric evaluation that includes a structured diagnostic interview (Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV Axis I Disorders (SCID))
Subjects who meet criteria for alcohol abuse and express an interest in stopping alcohol use and/or express an interest in treatment or are currently enrolled in treatment for alcoholism, or have sought treatment in the last 6 months.
history of counseling or psychotherapy; except family therapy centered around another family member
extended unwillingness to remain alcohol-free for 48 hours prior to test days;
for women: positive pregnancy test at screening or intention to engage in unprotected sex during the study
alcohol naïve
Adoptee and no contact with family members.

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Connecticut Healthcare System
West Haven, Connecticut, 06516

Other trials in United States

About this study

Read the detailed description

Males and females with a paternal family history of alcoholism have a high risk for developing alcoholism. These individuals have been shown to have decreased dysphoric responses to alcohol self-administration that may promote the excessive use of alcohol. Ethanol has been shown to be an antagonist at the N-methyl-D-aspartate (NMDA) glutamate receptor. We have recently shown that sober alcoholics have decreased dysphoric response to the NMDA antagonist, ketamine. We propose to test the hypothesis that this characteristic exists as a vulnerability factor in those individuals susceptible to develop alcoholism. Specifically, the objective is to determine whether individuals with a family history positive (FHP) for alcoholism will experience less dysphoric, anxiogenic, and psychotogenic effects to alcohol infusion when compared to family history negative (FHN) control subjects.

Male and female subjects, FHP (biological father and one other first degree relative) between the ages of 21-30, and matched controls (FHN) will complete 3 test days in a randomized balanced order under double-blind conditions. Test days will involve administration of placebo or one of two ethanol doses (target BrAc=40mg%, or target BrAc=100mg%) intravenously for 20 minutes, until the target BrAc is achieved. Once BrAc is achieved (40mg% or 100mg%) it will be maintained using a clamp procedure for over 60 minutes. Outcome measures include the Positive and Negative Symptom Scale, visual analog scales of mood state, (i.e. anxiety) and the Clinician-Administered Dissociative States Scale (CADSS) to measure perceptual responses to alcohol. Secondary measures include visual analog scales for high, similarity to ethanol, Mini Mental Status Examination (MMSE), Placement of electrodes, Biphasic Alcohol Effects Scale, Hopkins Verbal Learning, and number of drinks scale, aspects of craving for alcohol and tests of cognitive impairment.

Conditions: Alcoholism
Being tested: Ethanol High Dose, Ethanol Low Dose, and Placebo
Medical subject headings: Alcoholism

What participants receive

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

Ethanol High Dose, Ethanol Low Dose, and PlaceboDrug
Also called intravenous
Three test days will involve administration of placebo, ethanol high dose (BrAc=100mg%) or ethanol low dose (BrAc=40mg%)intravenously for approximately 20 minutes, until the target BrAc is achieved. Once BrAc is achieved (40mg% or 100mg%) it will be maintained using a clamp procedure for 60 minutes.

Study groups in NCT00612352
Study group	Role	What they receive
Family HIstory Positive	Active comparator	Subjects with a positive family history of alcoholism. Receives: Drug: Ethanol High Dose, Ethanol Low Dose, and Placebo
Family History Negative	Active comparator	Subjects with a negative family history of alcoholism. Receives: Drug: Ethanol High Dose, Ethanol Low Dose, and Placebo

What is being measured

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

Number of Drinks Felt Consumed at Baseline
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Measured: Baseline
Number of Drinks Felt Consumed at 10 Minutes
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Measured: 10 minutes
Number of Drinks Felt Consumed at 30 Minutes
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Measured: 30 minutes
Number of Drinks Felt Consumed at 110 Minutes
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Measured: 110 minutes
Number of Drinks Felt Consumed at 140 Minutes
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Measured: 140 minutes
Number of Drinks Felt Consumed at 170 Minutes
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Measured: 170 minutes
Number of Drinks Felt Consumed at 230 Minutes
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Measured: 230 minutes
Visual Analog Scale of Similarity to Alcohol - Baseline
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Measured: Baseline
Visual Analog Scale of Similarity to Alcohol -10 Minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Measured: 10 minutes
Visual Analog Scale of Similarity to Alcohol - 30 Minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Measured: 30 minutes
Visual Analog Scale of Similarity to Alcohol - 60 Minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Measured: 60 minutes
Visual Analog Scale of Similarity to Alcohol - 110 Minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Measured: 110 minutes
Visual Analog Scale of Similarity to Alcohol - 140 Minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Measured: 140 minutes
Visual Analog Scale of Similarity to Alcohol - 170 Minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Measured: 170 minutes
Visual Analog Scale of Similarity to Alcohol - 230 Minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Measured: 230 minutes

Secondary outcomes (40)

Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline
Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Measured: Baseline
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 10 Minutes
Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Measured: 10 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 30 Minutes
Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Measured: 30 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 60 Minutes
Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Measured: 60 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes
Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Measured: 110 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 140 Minutes
Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Measured: 140 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes
Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Measured: 170 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes
Self-report rating scale used to measure sedative effects (0 not at all sedated - 70 extremely sedated)
Measured: 230 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline
Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Measured: Baseline
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 10 Minutes
Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Measured: 10 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 30 Minutes
Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Measured: 30 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 60 Minutes
Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Measured: 60 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 110 Minutes
Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Measured: 110 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 140 Minutes
Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Measured: 140 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes
Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Measured: 170 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 240 Minutes
Self-report rating scale used to measure stimulant effects (0 not at all stimulated - 70 extremely stimulated)
Measured: 240 minutes
Visual Analog Scale (VAS) HIGH - Baseline
visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Measured: Baseline
Visual Analog Scale (VAS) HIGH - 10 Minutes
visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Measured: 10 minutes
Visual Analog Scale (VAS) HIGH - 30 Minutes
visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Measured: 30 minutes
Visual Analog Scale (VAS) HIGH - 60 Minutes
visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Measured: 60 minutes
Visual Analog Scale (VAS) HIGH - 110 Minutes
visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Measured: 110 minutes
Visual Analog Scale (VAS) HIGH - 140 Minutes
visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Measured: 140 minutes
Visual Analog Scale (VAS) HIGH - 170 Minutes
visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Measured: 170 minutes
Visual Analog Scale (VAS) HIGH - 240 Minutes
visual analog scale (VAS): self-report scale used to measure high (0 not at all High - 7 extremely High)
Measured: 240 minutes
Visual Analog Scale (VAS) Drowsy - Baseline
visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Measured: Baseline
Visual Analog Scale (VAS) Drowsy - 10 Minutes
visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Measured: 10 minutes
Visual Analog Scale (VAS) Drowsy - 30 Minutes
visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Measured: 30 minutes
Visual Analog Scale (VAS) Drowsy - 60 Minutes
visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Measured: 60 minutes
Visual Analog Scale (VAS) Drowsy - 110 Minutes
visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Measured: 110 minutes
Visual Analog Scale (VAS) Drowsy - 140 Minutes
visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Measured: 140 minutes
Visual Analog Scale (VAS) Drowsy - 170 Minutes
visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Measured: 170 minutes
Visual Analog Scale (VAS) Drowsy - 230 Minutes
visual analog scale (VAS): self-report scale used to measure Drowsy (0 not at all drowsy - 7 extremely drowsy)
Measured: 230 minutes
Hopkins Verbal Learning Task - Immediate Recall - Trial 1
Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)
Measured: 30 minutes - Trial 1
Hopkins Verbal Learning Task - Immediate Recall - Trial 2
Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)
Measured: 30 minutes - Trial 2
Hopkins Verbal Learning Task - Immediate Recall - Trial 3
Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 no words recalled - 12 all words recalled)
Measured: 30 minutes - Trial 3
Hopkins Verbal Learning Task - Delay Recall
Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Delay Recall: 30 minutes after Trials 1-3 were given) (0 no words recalled - 12 all words recalled)
Measured: 60 minutes
Pegboard Task - Baseline (Dominant Hand)
The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds
Measured: Baseline
Pegboard Task - 30 Minutes (Dominant Hand)
The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.
Measured: 30 minutes
Pegboard Task - Baseline (Non-Dominant Hand)
The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.
Measured: Baseline
Pegboard Task - 30 Minuites (Non-Dominant Hand)
The pegboard task is a measure of coordination that measures reaction time; how long a subject takes to insert pegs into a pegboard puzzle, first using their dominant hand then using their non-dominant hand. A quicker time indicates greater coordination. Scores are timed in seconds.
Measured: 30 minutes

Timeline

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

Mar 2001Jun 2015

First posted11 Feb 2008 (estimated)
Study startMar 2001
Primary completionJun 2015
Study completionJun 2015

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for AlcoholismStudies 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 N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00612352
Sponsor's protocol ID: 0304025194
Other IDs: VA Alcohol Research Center, P50AA012870
Status last verified: Oct 2021
First submitted: 27 Dec 2007
Last updated: 26 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Ralevski E, Perrino A, Acampora G, Koretski J, Limoncelli D, Petrakis I. Analgesic effects of ethanol are influenced by family history of alcoholism and neuroticism. Alcohol Clin Exp Res. 2010 Aug;34(8):1433-41. doi: 10.1111/j.1530-0277.2010.01228.x. Epub 2010 May 21.
PubMed 20497133
Perrino AC Jr, Ralevski E, Acampora G, Edgecombe J, Limoncelli D, Petrakis IL. Ethanol and pain sensitivity: effects in healthy subjects using an acute pain paradigm. Alcohol Clin Exp Res. 2008 Jun;32(6):952-8. doi: 10.1111/j.1530-0277.2008.00653.x. Epub 2008 Apr 26.
PubMed 18445106

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intravenous Alcohol Administration Using BrAc Method in Healthy Subjects With and Without a Family History of Alcoholism
ClinicalTrials.gov ID: NCT00612352
Acronym / sponsor ID: 0304025194
Conditions: Alcoholism
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: VA Connecticut Healthcare System, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: Mar 2001
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 11 Feb 2008 (estimated)
Results: Posted 24 Feb 2017

Clinical summary

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

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Family HIstory Positive	Active comparator	Drug: Ethanol High Dose, Ethanol Low Dose, and PlaceboSubjects with a positive family history of alcoholism.
Family History Negative	Active comparator	Drug: Ethanol High Dose, Ethanol Low Dose, and PlaceboSubjects with a negative family history of alcoholism.

Who may qualify

Ages: 21 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Male and female between the ages of 21 and 30 years;
medically and neurologically healthy on the basis of history, physical examination, EKG, Screening laboratories absence of current and/or past substance abuse on the basis of history and urine toxicology and breath alcohol levels at screening and on each test day.
For Family History Positive (FHP) Subjects: 1) Biological father and another first or second-degree biological relative with history of alcoholism by Family History Assessment Module (FHAM) developed by COGA.

Key exclusion criteria (7 listed)

DSM-IV psychiatric and substance abuse (excluding alcohol abuse) diagnosis by history on psychiatric evaluation that includes a structured diagnostic interview (Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV Axis I Disorders (SCID))
Subjects who meet criteria for alcohol abuse and express an interest in stopping alcohol use and/or express an interest in treatment or are currently enrolled in treatment for alcoholism, or have sought treatment in the last 6 months.
history of counseling or psychotherapy; except family therapy centered around another family member
extended unwillingness to remain alcohol-free for 48 hours prior to test days;
for women: positive pregnancy test at screening or intention to engage in unprotected sex during the study

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
Ethanol High Dose, Ethanol Low Dose, and PlaceboAlso: intravenousThree test days will involve administration of placebo, ethanol high dose (BrAc=100mg%) or ethanol low dose (BrAc=40mg%)intravenously for approximately 20 minutes, until the target BrAc is achieved. Once BrAc is achieved (40mg% or 100mg%) it will be maintained using a clamp procedure for 60 minutes.	Drug	Family HIstory Positive, Family History Negative

Primary outcome

Number of Drinks Felt Consumed at Baseline
Time frame: Baseline
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Number of Drinks Felt Consumed at 10 Minutes
Time frame: 10 minutes
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Number of Drinks Felt Consumed at 30 Minutes
Time frame: 30 minutes
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Number of Drinks Felt Consumed at 110 Minutes
Time frame: 110 minutes
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Number of Drinks Felt Consumed at 140 Minutes
Time frame: 140 minutes
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Number of Drinks Felt Consumed at 170 Minutes
Time frame: 170 minutes
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Number of Drinks Felt Consumed at 230 Minutes
Time frame: 230 minutes
The Number of Drinks Scale asks Subjects to report on the number of alcoholic drinks they felt they had consumed.
Visual Analog Scale of Similarity to Alcohol - Baseline
Time frame: Baseline
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Visual Analog Scale of Similarity to Alcohol -10 Minutes
Time frame: 10 minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Visual Analog Scale of Similarity to Alcohol - 30 Minutes
Time frame: 30 minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Visual Analog Scale of Similarity to Alcohol - 60 Minutes
Time frame: 60 minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Visual Analog Scale of Similarity to Alcohol - 110 Minutes
Time frame: 110 minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Visual Analog Scale of Similarity to Alcohol - 140 Minutes
Time frame: 140 minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Visual Analog Scale of Similarity to Alcohol - 170 Minutes
Time frame: 170 minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol
Visual Analog Scale of Similarity to Alcohol - 230 Minutes
Time frame: 230 minutes
Visual Analog Scale of Similarity to Alcohol data using the Likert scale (0 Not at all similar to alcohol - 7 Extremely similar to alcohol) evaluating the similarity of drug effects to alcohol

40 secondary outcomes

Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline
Time frame: Baseline
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 10 Minutes
Time frame: 10 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 30 Minutes
Time frame: 30 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 60 Minutes
Time frame: 60 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes
Time frame: 110 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 140 Minutes
Time frame: 140 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes
Time frame: 170 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes
Time frame: 230 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline
Time frame: Baseline
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 10 Minutes
Time frame: 10 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 30 Minutes
Time frame: 30 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 60 Minutes
Time frame: 60 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 110 Minutes
Time frame: 110 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 140 Minutes
Time frame: 140 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes
Time frame: 170 minutes
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 240 Minutes
Time frame: 240 minutes
Visual Analog Scale (VAS) HIGH - Baseline
Time frame: Baseline
Visual Analog Scale (VAS) HIGH - 10 Minutes
Time frame: 10 minutes
Visual Analog Scale (VAS) HIGH - 30 Minutes
Time frame: 30 minutes
Visual Analog Scale (VAS) HIGH - 60 Minutes
Time frame: 60 minutes
Visual Analog Scale (VAS) HIGH - 110 Minutes
Time frame: 110 minutes
Visual Analog Scale (VAS) HIGH - 140 Minutes
Time frame: 140 minutes
Visual Analog Scale (VAS) HIGH - 170 Minutes
Time frame: 170 minutes
Visual Analog Scale (VAS) HIGH - 240 Minutes
Time frame: 240 minutes
Visual Analog Scale (VAS) Drowsy - Baseline
Time frame: Baseline
Visual Analog Scale (VAS) Drowsy - 10 Minutes
Time frame: 10 minutes
Visual Analog Scale (VAS) Drowsy - 30 Minutes
Time frame: 30 minutes
Visual Analog Scale (VAS) Drowsy - 60 Minutes
Time frame: 60 minutes
Visual Analog Scale (VAS) Drowsy - 110 Minutes
Time frame: 110 minutes
Visual Analog Scale (VAS) Drowsy - 140 Minutes
Time frame: 140 minutes
Visual Analog Scale (VAS) Drowsy - 170 Minutes
Time frame: 170 minutes
Visual Analog Scale (VAS) Drowsy - 230 Minutes
Time frame: 230 minutes
Hopkins Verbal Learning Task - Immediate Recall - Trial 1
Time frame: 30 minutes - Trial 1
Hopkins Verbal Learning Task - Immediate Recall - Trial 2
Time frame: 30 minutes - Trial 2
Hopkins Verbal Learning Task - Immediate Recall - Trial 3
Time frame: 30 minutes - Trial 3
Hopkins Verbal Learning Task - Delay Recall
Time frame: 60 minutes
Pegboard Task - Baseline (Dominant Hand)
Time frame: Baseline
Pegboard Task - 30 Minutes (Dominant Hand)
Time frame: 30 minutes
Pegboard Task - Baseline (Non-Dominant Hand)
Time frame: Baseline
Pegboard Task - 30 Minuites (Non-Dominant Hand)
Time frame: 30 minutes

Results and safety

Results posted to the registry on 24 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Family History Positive	65	56
Family History Negative	115	109

Primary outcome: Number of Drinks Felt Consumed at Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: drinks felt consumed

Measure	Family History Positive n = 65	Family History Negative n = 115
Placebo	0 (0)	0 (0)
Alcohol 40mg%	0 (0)	0 (0)
Alcohol 100mg%	0 (0)	0.04 (0.23)

Population analysed: All available data was utilized in the analysis using mixed models.

Primary outcome: Number of Drinks Felt Consumed at 10 Minutes

Time frame: 10 minutes. Mean (Standard Deviation). Unit: drinks felt consumed

Measure	Family History Positive n = 65	Family History Negative n = 115
Placebo	0.07 (0.42)	0.08 (0.37)
Alcohol 40mg%	0.49 (0.8)	0.7 (0.92)
Alcohol 100mg%	0.76 (1.07)	1.15 (1.18)

Population analysed: All available data was utilized in the analysis using mixed models.

Primary outcome: Number of Drinks Felt Consumed at 30 Minutes

Time frame: 30 minutes. Mean (Standard Deviation). Unit: drinks felt consumed

Measure	Family History Positive n = 65	Family History Negative n = 115
Placebo	0.2 (0.5)	0.27 (0.67)
Alcohol 40mg%	1.88 (1.11)	2.03 (1.68)
Alcohol 100mg%	3.65 (1.61)	3.86 (2.0)

Population analysed: All available data was utilized in the analysis using mixed models.

Primary outcome: Number of Drinks Felt Consumed at 110 Minutes

Time frame: 110 minutes. Mean (Standard Deviation). Unit: drinks felt consumed

Measure	Family History Positive n = 65	Family History Negative n = 115
Placebo	0.1 (0.4)	0.09 (0.4)
Alcohol 40mg%	0.97 (0.97)	1.2 (1.39)
Alcohol 100mg%	3.22 (1.61)	3.64 (2.0)

Population analysed: All available data was utilized in the analysis using mixed models.

40 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Family History Positive	0 of 65 (0%)	1 of 65 (1.5%)	Not reported
Family History Negative	0 of 115 (0%)	0 of 115 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20497133Ralevski E, Perrino A, Acampora G, Koretski J, Limoncelli D, Petrakis I. Analgesic effects of ethanol are influenced by family history of alcoholism and neuroticism. Alcohol Clin Exp Res. 2010 Aug;34(8):1433-41. doi: 10.1111/j.1530-0277.2010.01228.x. Epub 2010 May 21.
Results publication: PubMed 18445106Perrino AC Jr, Ralevski E, Acampora G, Edgecombe J, Limoncelli D, Petrakis IL. Ethanol and pain sensitivity: effects in healthy subjects using an acute pain paradigm. Alcohol Clin Exp Res. 2008 Jun;32(6):952-8. doi: 10.1111/j.1530-0277.2008.00653.x. Epub 2008 Apr 26.

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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 L Petrakis, MD principal investigator

Yale University

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

Questions about this trial

What is this clinical trial studying?

A study of Alcoholism, 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 3 inclusion and 7 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 26 Oct 2021. 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 24 Feb 2017). 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?

Number of Drinks Felt Consumed at Baseline (time frame: Baseline). The study lists 15 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 NCT00612352, which also lists 2 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 26 Oct 2021.