CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 57 enrolled
Drug / intervention
D-Cycloserine PO and Glycine IV +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00635102
NCT00635102N/ACompleted

Glycine and Oral D-Cycloserine in Alcoholic Patients and Healthy Subjects

Yale University·interventional·Posted Mar 13, 2008·Updated Dec 16, 2016

In Brief

A clinical study evaluating D-Cycloserine PO and Glycine IV, Placebo D-Cycloserine PO and placebo Glycine IV, and 2 other interventions for Alcohol Dependence. Completed, enrolled 57 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 13, 2008
Enrollment StartOct 1, 1997
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 18.3 years ago

Interventions

D-Cycloserine PO and Glycine IVdrug

Test days will involve administration of D-Cycloserine in the morning in pill form then 4 hours later a 30 minute infusion of Glycine.

Placebo D-Cycloserine PO and placebo Glycine IVdrug

Placebo

Placebo D-Cycloserine PO and Glycine IVdrug

D-Cycloserine PO and placebo Glycine IVdrug