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| ID | Type | Description | Link |
|---|---|---|---|
| VA Merit Grant | Other Grant/Funding Number | VA Merit Grant |
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Question #1: Will glycine ameliorate cognitive deficits? Hypothesis #1: Based on positive findings conducted with glycine and milacemide, a glycine prodrug, in schizophrenia and dementia, we expect that glycine will ameliorate cognitive deficits.
Question #2: Will alcoholic patients show enhanced endocrinal effects to glycine? Hypothesis #2: Based on the dose-related effects of glycine in healthy subjects, we expect that glycine will increase the endocrinal response to glycine in alcoholic patients with, supposedly, dysregulated NMDA receptor function.
Question #3: Will D-cycloserine have ethanol-like effects? Hypothesis #3: If inhibition of NMDA receptor function is fundamental to the subjective effects of ethanol, then the NMDA antagonist properties of D-cycloserine should be recognized as ethanol-like (relative to placebo) in recently detoxified alcoholics and healthy subjects.
Question #4: Will D-cycloserine reverse cognitive benefits of glycine? Hypothesis 4: Based on the dose related NMDA antagonist activity of D-cycloserine, we expect that D-cycloserine will compete with the agonist activity of glycine and therefore it will reverse the cognitive benefits of glycine.
Question #5: Will D-cycloserine inhibit endocrinal effects of glycine? Hypothesis #5: If the agonist activity of glycine is necessary to determine endocrine response, then the dose-related NMDA antagonist properties of D-cycloserine should block these effects.
The purpose of this study is to investigate the interaction between glycine and D-cycloserine in alcoholic patients and healthy subjects. Preclinical studies have shown that compounds acting at the glycine site of the N-methyl-D-aspartate (NMDA) receptor complex, such as glycine, may reverse the effects of ethanol on the NMDA receptor function (Rabe et al., 1990). The amino acid glycine is a co-agonist of the NMDA receptor complex (Kemp et al., 1993). It binds to the strychnine-insensitive site and positively modulates the NMDA receptor (Mc Donald et al., 1990). Physiologically, the glycine site is not saturated, and administration of glycine can potentiate NMDA receptor mediated responses. In contrast, D-cycloserine (Hood et al., 1989) is a partial-agonist at the glycine site of the NMDA receptor, with dose-dependent NMDA antagonist properties. The NMDA antagonist activity of D-cycloserine should produce ethanol like-effects that can be reversed by the agonist glycine. This study is intended to evaluate possible contributions of the glycine site to the reduction of cognitive deficits of alcoholism and complements the current work at VA Connecticut Healthcare System on the NMDA antagonists in alcoholic and healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol dependent | Active Comparator | Alcohol dependent patients will receive 4 interventions |
|
| Healthy subjects | Active Comparator | Healthy subjects will receive 4 interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-Cycloserine PO and Glycine IV | Drug | Test days will involve administration of D-Cycloserine in the morning in pill form then 4 hours later a 30 minute infusion of Glycine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scales of Similarity to Alcohol - Baseline | Visual Analog Scales 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 Scales of Similarity to Alcohol 60 Minutes Prior to Glycine Infusion | Visual Analog Scales 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 prior to Glycine infusion |
| Visual Analog Scales of Similarity to Alcohol 30 Minutes | Visual Analog Scales 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 Scales of Similarity to Alcohol 60 Minutes | Visual Analog Scales 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 Scales of Similarity to Alcohol 120 Minutes | Visual Analog Scales 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 | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Drinks Felt Consumed at 60 Minutes Prior to Glycine Infusion | The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed. | 60 minutes prior to Glycine infusion |
| Number of Drinks Felt Consumed at 30 Minutes |
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Inclusion / Exclusion Criteria Alcoholic subjects:
Inclusion / Exclusion Criteria Healthy subjects:
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| Name | Affiliation | Role |
|---|---|---|
| John H Krystal, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System | West Haven | Connecticut | 06516 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21124304 | Result | Krystal JH, Petrakis IL, Limoncelli D, Nappi SK, Trevisan L, Pittman B, D'Souza DC, Suckow RF. Characterization of the interactive effects of glycine and D-cycloserine in men: further evidence for enhanced NMDA receptor function associated with human alcohol dependence. Neuropsychopharmacology. 2011 Feb;36(3):701-10. doi: 10.1038/npp.2010.203. Epub 2010 Dec 1. |
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Alcoholic subjects were recruited from the Substance Abuse Treatment Program at VA Connecticut Healthcare Systems in West Haven, through advertisements in newspapers and postings in the community. Healthy subjects were recruited from the advertisements in newspapers and postings throughout the community.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alcoholic Subjects | Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet Diagnostic and Statistical manual (DSM) IV criteria for alcohol dependence by structured clinical interview |
| FG001 | Healthy Subjects | Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the structured clinical interview (SCID). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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57 individuals signed consent forms, of the 57 individuals 27 were alcohol dependent and 30 were healthy subjects. Of the alcohol dependent subjects 20 completed, 3 completed part of the study and 4 withdrew from the study. Of the healthy subjects, 22 completed, 4 completed part of the study and 4 withdrew from the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcoholic Subjects | Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs. who meet DSM IV criteria for alcohol dependence by structured clinical interview |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Scales of Similarity to Alcohol - Baseline | Visual Analog Scales 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 Scales 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alcoholic Subjects |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr John Krystal | Yale University School of Medicine | 203-785-6396 | john.krystal@yale.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003523 | Cycloserine |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Placebo D-Cycloserine PO and placebo Glycine IV | Drug | Placebo |
|
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| Placebo D-Cycloserine PO and Glycine IV | Drug |
|
| D-Cycloserine PO and placebo Glycine IV | Drug |
|
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 60 Minutes | The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed. | 60 minutes |
| Number of Drinks Felt Consumed at 120 Minutes | The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed. | 120 minutes |
| Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - Baseline | Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol | Baseline |
| Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation 60 Minutes Prior to Glycine Infusion | Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol | 60 minutes prior to Glycine infusion |
| Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 30 Minutes | Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol | 30 minutes |
| Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 60 Minutes | Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol | 60 minutes |
| Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 120 Minutes | Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol | 120 minutes |
| Visual Analog Scales (VAS) - Baseline | Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely) | Baseline |
| Visual Analog Scales (VAS) - 60 Minutes Prior to Glycine Infusion | Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely) | 60 minutes prior to Glycine infusion |
| Visual Analog Scales (VAS) - 30 Minutes | Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely) | 30 minutes |
| Visual Analog Scales (VAS) - 60 Minutes | Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely) | 60 minutes |
| Visual Analog Scales (VAS) - 120 Minutes | Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely) | 120 minutes |
| Alcohol Craving Scale (ACS) Subscale: Desire to Drink- Baseline | Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol) | Baseline |
| Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes Prior to Glycine Infusion | Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol) | 60 minutes prior to Glycine infusion |
| Alcohol Craving Scale (ACS) Subscale: Desire to Drink: - 30 Minutes | Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol) | 30 minutes |
| Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes | Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol) | 60 minutes |
| Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 120 Minutes | Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol) | 120 minutes |
| Alcohol Craving Scale (ACS) Subscale: Mood Improvement - Baseline | Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely) | Baseline |
| Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes Prior to Glycine Infusion | Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely) | 60 minutes prior to Glycine infusion |
| Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 30 Minutes | Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely) | 30 minutes |
| Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes | Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely) | 60 minutes |
| Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 120 Minutes | Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely) | 120 minutes |
| Alcohol Craving Scale (ACS) Subscale: Discomfort - Baseline | Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely) | Baseline |
| Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes Prior to Glycine Infusion | Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely) | 60 minutes prior to Glycine infusion |
| Alcohol Craving Scale (ACS) Subscale: Discomfort - 30 Minutes | Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely) | 30 minutes |
| Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes | Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely) | 60 minutes |
| Alcohol Craving Scale (ACS) Subscale: Discomfort - 120 Minutes | Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely) | 120 minutes |
| Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - Baseline | Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely) | Baseline |
| Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes Prior to Glycine Infusion | Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely) | 60 minutes prior to Glycine infusion |
| Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 30 Minutes | Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely) | 30 minutes |
| Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes | Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely) | 60 minutes |
| Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 120 Minutes | Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely) | 120 minutes |
| Continuous Performance Task (CPT) - Distractibility A-Prime - 30 Minutes | gordon diagnostic system is a continuous performance task (CPT) to measure distractibility - (A-Prime score range 0 minimum - 1 maximum - the higher number the better the performance) | 30 minutes |
| Continuous Performance Task (CPT) - Vigilance - A-Prime Score 30 Minutes | gordon diagnostic system is a continuous performance task (CPT) to measure Vigilance - (A-Prime score range 0 minimum - 1 maximum - The higher number the better the performance) | 30 minutes |
| Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - 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) | 60 minutes - Trial 1 |
| Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - 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) | 60 minutes - Trial 2 |
| Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - 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) | 60 minutes - Trial 3 |
| Hopkins Verbal Learning Task - Delay Recall - 90 Minutes | 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) | 90 minutes |
| Healthy Subjects |
Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Healthy Subjects | Male or female (post-menopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control during the testing period) between the age of 21 and 70 yrs who have been absence of a lifetime substance abuse diagnosis by the non-patient version of the SCID. |
|
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| Primary | Visual Analog Scales of Similarity to Alcohol 60 Minutes Prior to Glycine Infusion | Visual Analog Scales 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 Scales 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 | Posted | Mean | Standard Deviation | units on a scale | 60 minutes prior to Glycine infusion |
|
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| Primary | Visual Analog Scales of Similarity to Alcohol 30 Minutes | Visual Analog Scales 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 Scales 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 | Posted | Mean | Standard Deviation | units on a scale | 30 minutes |
|
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|
| Primary | Visual Analog Scales of Similarity to Alcohol 60 Minutes | Visual Analog Scales 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 Scales 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 | Posted | Mean | Standard Deviation | units on a scale | 60 minutes |
|
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| Primary | Visual Analog Scales of Similarity to Alcohol 120 Minutes | Visual Analog Scales 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 Scales 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 | Posted | Mean | Standard Deviation | units on a scale | 120 minutes |
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| Secondary | Number of Drinks Felt Consumed at 60 Minutes Prior to Glycine Infusion | The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed. | The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed. | Posted | Mean | Standard Deviation | drinks felt consumed | 60 minutes prior to Glycine infusion |
|
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| Secondary | 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. | The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed. | Posted | Mean | Standard Deviation | Number of Drinks Felt Consumed | 30 minutes |
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| Secondary | Number of Drinks Felt Consumed at 60 Minutes | The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed. | The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed. | Posted | Mean | Standard Deviation | Number of Drinks Felt Consumed | 60 minutes |
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| Secondary | Number of Drinks Felt Consumed at 120 Minutes | The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed. | The Number of Drinks Scale asks subjects to report on the number of alcoholic drinks they felt they had consumed. | Posted | Mean | Standard Deviation | Number of Drinks Felt Consumed | 120 minutes |
|
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| Secondary | Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - Baseline | Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol | Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
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| Secondary | Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation 60 Minutes Prior to Glycine Infusion | Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol | Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol | Posted | Mean | Standard Deviation | units on a scale | 60 minutes prior to Glycine infusion |
|
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| Secondary | Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 30 Minutes | Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol | Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol | Posted | Mean | Standard Deviation | units on a scale | 30 minutes |
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| Secondary | Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 60 Minutes | Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol | Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol | Posted | Mean | Standard Deviation | units on a scale | 60 minutes |
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| Secondary | Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 120 Minutes | Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol | Self-report rating scale used to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol | Posted | Mean | Standard Deviation | units on a scale | 120 minutes |
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| Secondary | Visual Analog Scales (VAS) - Baseline | Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Secondary | Visual Analog Scales (VAS) - 60 Minutes Prior to Glycine Infusion | Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely) | Posted | Mean | Standard Deviation | units on a scale | 60 minutes prior to Glycine infusion |
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| Secondary | Visual Analog Scales (VAS) - 30 Minutes | Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely) | Posted | Mean | Standard Deviation | units on a scale | 30 minutes |
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| Secondary | Visual Analog Scales (VAS) - 60 Minutes | Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely) | Posted | Mean | Standard Deviation | units on a scale | 60 minutes |
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| Secondary | Visual Analog Scales (VAS) - 120 Minutes | Visual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely) | Posted | Mean | Standard Deviation | units on a scale | 120 minutes |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Desire to Drink- Baseline | Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes Prior to Glycine Infusion | Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol) | Posted | Mean | Standard Deviation | units on a scale | 60 minutes prior to Glycine infusion |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Desire to Drink: - 30 Minutes | Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol) | Posted | Mean | Standard Deviation | units on a scale | 30 minutes |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes | Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol) | Posted | Mean | Standard Deviation | units on a scale | 60 minutes |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 120 Minutes | Alcohol Craving Scale (ACS) Subscale: Desire to drink: Self-report rating scale used to measure desire to drink alcohol (0 No desire to drink alcohol - 100 Definitely desire to drink alcohol) | Posted | Mean | Standard Deviation | units on a scale | 120 minutes |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Mood Improvement - Baseline | Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes Prior to Glycine Infusion | Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely) | Posted | Mean | Standard Deviation | units on a scale | 60 minutes prior to Glycine infusion |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 30 Minutes | Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely) | Posted | Mean | Standard Deviation | units on a scale | 30 minutes |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes | Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely) | Posted | Mean | Standard Deviation | units on a scale | 60 minutes |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 120 Minutes | Alcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely) | Posted | Mean | Standard Deviation | units on a scale | 120 minutes |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Discomfort - Baseline | Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes Prior to Glycine Infusion | Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely) | Posted | Mean | Standard Deviation | units on a scale | 60 minutes prior to Glycine infusion |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Discomfort - 30 Minutes | Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely) | Posted | Mean | Standard Deviation | units on a scale | 30 minutes |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes | Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely) | Posted | Mean | Standard Deviation | units on a scale | 60 minutes |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Discomfort - 120 Minutes | Alcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely) | Posted | Mean | Standard Deviation | units on a scale | 120 minutes |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - Baseline | Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes Prior to Glycine Infusion | Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely) | Posted | Mean | Standard Deviation | units on a scale | 60 minutes prior to Glycine infusion |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 30 Minutes | Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely) | Posted | Mean | Standard Deviation | units on a scale | 30 minutes |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes | Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely) | Posted | Mean | Standard Deviation | units on a scale | 60 minutes |
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| Secondary | Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 120 Minutes | Alcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely) | Posted | Mean | Standard Deviation | units on a scale | 120 minutes |
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| Secondary | Continuous Performance Task (CPT) - Distractibility A-Prime - 30 Minutes | gordon diagnostic system is a continuous performance task (CPT) to measure distractibility - (A-Prime score range 0 minimum - 1 maximum - the higher number the better the performance) | Posted | Mean | Standard Deviation | units on a scale | 30 minutes |
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| Secondary | Continuous Performance Task (CPT) - Vigilance - A-Prime Score 30 Minutes | gordon diagnostic system is a continuous performance task (CPT) to measure Vigilance - (A-Prime score range 0 minimum - 1 maximum - The higher number the better the performance) | Posted | Mean | Standard Deviation | units on a scale | 30 minutes |
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| Secondary | Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - 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) | Posted | Mean | Standard Deviation | units on a scale | 60 minutes - Trial 1 |
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| Secondary | Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - 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) | Posted | Mean | Standard Deviation | units on a scale | 60 minutes - Trial 2 |
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| Secondary | Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - 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) | Posted | Mean | Standard Deviation | units on a scale | 60 minutes - Trial 3 |
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| Secondary | Hopkins Verbal Learning Task - Delay Recall - 90 Minutes | 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) | Posted | Mean | Standard Deviation | units on a scale | 90 minutes |
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|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Healthy Subjects | 0 | 30 | 0 | 30 |
Not provided
Not provided
Not provided
| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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