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CompletedNot applicableResults posted

Ketamine/Placebo Family History Positive Study

NCT00588952 · Yale University

Closed to entry
Status
Not accepting participants
Not applicable
Phase
99
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation

    Measured over Baseline

  • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation

    Measured over 15 minutes

  • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation

    Measured over 45 minutes

  • Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation

    Measured over 80 minutes

  • Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation

    Measured over Baseline

  • Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation

    Measured over 15 minutes

  • Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation

    Measured over 45 minutes

  • Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation

    Measured over 80 minutes

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 30 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: 1. Male and female between the ages of 21 and 30 years 2. Medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratories, absence of current and/or past substance abuse For Family History Positive (FHP) Subjects: Biological father and another first or second-degree biological relative with history of alcoholism Exclusion Criteria: 1. Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) psychiatric and substance abuse diagnosis by history on psychiatric evaluation that includes a structured diagnostic interview (The Semi-Structured Assessment for the Genetics of alcoholism: SSAGA) and the Wisconsin Scales of Psychosis Proneness 2. History of counseling or psychotherapy; except family therapy centered around another family member 3. Extended unwillingness to remain alcohol-free for three days prior to testing and for the duration of the testing period 4. For women: positive pregnancy test at screening or intention to engage in unprotected sex during the study 5. Alcohol naïve 6. Previous bad experience with ketamine 7. Adoptee and no contact with family members For Family History Negative (FHN) Subjects: NO family history of alcoholism in any first or second-degree relatives (subjects must reliably report on three first-degree relatives)

Where

1 study site

FacilityCityRegionCountry
VA Connecticut Healthcare SystemWest HavenConnecticutUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT00588952 on ClinicalTrials.gov →

Last updated in the registry 2021-10-06. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits