N/A
N=99
Ketamine/Placebo Family History Positive Study
Alcoholism
Bottom Line
View on ClinicalTrials.gov: NCT00588952 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation — 0.63; 0.96; 0.71; 1.25 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ketamine and Placebo (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation |
7.46; 9.99; 1.07; 0.92 | — |
| PRIMARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation |
7.46; 9.99; 1.07; 0.92 | — |
| PRIMARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation |
7.46; 9.99; 1.07; 0.92 | — |
| PRIMARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation |
7.46; 9.99; 1.07; 0.92 | — |
| PRIMARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation |
3.81; 3.02; 1.61; 2.12 | — |
| PRIMARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation |
3.81; 3.02; 1.61; 2.12 | — |
| PRIMARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation |
3.81; 3.02; 1.61; 2.12 | — |
| PRIMARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation |
3.81; 3.02; 1.61; 2.12 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
For Family History Positive (FHP) Subjects: Biological father and another first or second-degree biological relative with history of alcoholism
Exclusion Criteria
- 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
- History of counseling or psychotherapy; except family therapy centered around another family member
- Extended unwillingness to remain alcohol-free for three days prior to testing and for the duration of the testing period
- For women: positive pregnancy test at screening or intention to engage in unprotected sex during the study
- Alcohol naïve
- Previous bad experience with ketamine
- 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)
Data sourced from ClinicalTrials.gov (NCT00588952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.