NCT00612352

Brief 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 transition from moderate to excessive use of alcohol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2007

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 24, 2017

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

14.3 years

First QC Date

December 27, 2007

Results QC Date

January 3, 2017

Last Update Submit

October 1, 2021

Conditions

Alcoholism

Outcome Measures

Primary Outcomes (15)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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

    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

    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

    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

    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

    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

    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

    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

    230 minutes

Secondary Outcomes (40)

  • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline

    Baseline

  • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 10 Minutes

    10 minutes

  • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 30 Minutes

    30 minutes

  • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 60 Minutes

    60 minutes

  • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes

    110 minutes

  • +35 more secondary outcomes

Study Arms (2)

Family HIstory Positive

ACTIVE COMPARATOR

Subjects with a positive family history of alcoholism.

Drug: Ethanol High Dose, Ethanol Low Dose, and Placebo

Family History Negative

ACTIVE COMPARATOR

Subjects with a negative family history of alcoholism.

Drug: Ethanol High Dose, Ethanol Low Dose, and Placebo

Interventions

Ethanol High Dose, Ethanol Low Dose, and PlaceboDRUG

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.

Also known as: intravenous
Family HIstory PositiveFamily History Negative

Eligibility Criteria

Age21 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

Related Publications (2)

  • 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.

    PMID: 20497133RESULT

  • 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.

    PMID: 18445106RESULT

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Results Point of Contact

Title
Ismene Petrakis
Organization
Yale University
ismene.petrakis@yale.edu

Study Officials

  • Ismene L Petrakis, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2007

First Posted

February 11, 2008

Study Start

March 1, 2001

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 26, 2021

Results First Posted

February 24, 2017

Record last verified: 2021-10

Locations

US(1)