Trial Outcomes & Findings for Glycine and Oral D-Cycloserine in Alcoholic Patients and Healthy Subjects (NCT NCT00635102)
NCT ID: NCT00635102
Last Updated: 2016-12-16
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
Baseline
Results posted on
2016-12-16
Participant Flow
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.
Participant milestones
| Measure |
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
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
30
|
|
Overall Study
COMPLETED
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
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
|
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).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
8
|
Baseline Characteristics
Glycine and Oral D-Cycloserine in Alcoholic Patients and Healthy Subjects
Baseline characteristics by cohort
| Measure |
Alcoholic Subjects
n=27 Participants
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
|
Healthy Subjects
n=30 Participants
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.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 9.5 • n=93 Participants
|
31.9 years
STANDARD_DEVIATION 10 • n=4 Participants
|
37.9 years
STANDARD_DEVIATION .17 • n=27 Participants
|
|
Gender
Female
|
0 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Gender
Male
|
27 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=93 Participants
|
30 participants
n=4 Participants
|
57 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Visual Analog Scales of Similarity to Alcohol - Baseline
Glycine / Cycloserine
|
0.18 units on a scale
Standard Deviation 0.50
|
0.05 units on a scale
Standard Deviation 0.21
|
|
Visual Analog Scales of Similarity to Alcohol - Baseline
Glycine / Placebo
|
0.25 units on a scale
Standard Deviation 1.12
|
0.04 units on a scale
Standard Deviation 0.20
|
|
Visual Analog Scales of Similarity to Alcohol - Baseline
Placebo / Cycloserine
|
0.10 units on a scale
Standard Deviation 0.30
|
0.04 units on a scale
Standard Deviation 0.20
|
|
Visual Analog Scales of Similarity to Alcohol - Baseline
Placebo / Placebo
|
0.24 units on a scale
Standard Deviation 0.54
|
0 units on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 60 minutes prior to Glycine infusionPopulation: 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
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Visual Analog Scales of Similarity to Alcohol 60 Minutes Prior to Glycine Infusion
Placebo / Cycloserine
|
0.48 units on a scale
Standard Deviation 0.87
|
1.17 units on a scale
Standard Deviation 1.66
|
|
Visual Analog Scales of Similarity to Alcohol 60 Minutes Prior to Glycine Infusion
Placebo / Placebo
|
0.43 units on a scale
Standard Deviation 0.93
|
.025 units on a scale
Standard Deviation 0.61
|
|
Visual Analog Scales of Similarity to Alcohol 60 Minutes Prior to Glycine Infusion
Glycine / Cycloserine
|
0.77 units on a scale
Standard Deviation 1.77
|
1.41 units on a scale
Standard Deviation 1.65
|
|
Visual Analog Scales of Similarity to Alcohol 60 Minutes Prior to Glycine Infusion
Glycine / Placebo
|
0.65 units on a scale
Standard Deviation 1.27
|
0.67 units on a scale
Standard Deviation 1.63
|
PRIMARY outcome
Timeframe: 30 minutesPopulation: 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
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Visual Analog Scales of Similarity to Alcohol 30 Minutes
Glycine / Cycloserine
|
0.57 units on a scale
Standard Deviation 1.17
|
1.81 units on a scale
Standard Deviation 1.89
|
|
Visual Analog Scales of Similarity to Alcohol 30 Minutes
Glycine / Placebo
|
0.60 units on a scale
Standard Deviation 1.14
|
0.71 units on a scale
Standard Deviation 1.45
|
|
Visual Analog Scales of Similarity to Alcohol 30 Minutes
Placebo / Cycloserine
|
1.05 units on a scale
Standard Deviation 1.56
|
1.21 units on a scale
Standard Deviation 2.13
|
|
Visual Analog Scales of Similarity to Alcohol 30 Minutes
Placebo / Placebo
|
0.43 units on a scale
Standard Deviation 0.98
|
0.13 units on a scale
Standard Deviation 0.34
|
PRIMARY outcome
Timeframe: 60 minutesPopulation: 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
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Visual Analog Scales of Similarity to Alcohol 60 Minutes
Placebo / Cycloserine
|
0.81 units on a scale
Standard Deviation 1.21
|
1.46 units on a scale
Standard Deviation 2.17
|
|
Visual Analog Scales of Similarity to Alcohol 60 Minutes
Placebo / Placebo
|
0.24 units on a scale
Standard Deviation 0.54
|
0.13 units on a scale
Standard Deviation 0.45
|
|
Visual Analog Scales of Similarity to Alcohol 60 Minutes
Glycine / Cycloserine
|
0.67 units on a scale
Standard Deviation 1.494
|
1.81 units on a scale
Standard Deviation 1.72
|
|
Visual Analog Scales of Similarity to Alcohol 60 Minutes
Glycine / Placebo
|
0.75 units on a scale
Standard Deviation 1.52
|
0.70 units on a scale
Standard Deviation 1.43
|
PRIMARY outcome
Timeframe: 120 minutesPopulation: 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
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Visual Analog Scales of Similarity to Alcohol 120 Minutes
Glycine / Cycloserine
|
0.43 units on a scale
Standard Deviation 1.08
|
0.41 units on a scale
Standard Deviation 1.14
|
|
Visual Analog Scales of Similarity to Alcohol 120 Minutes
Glycine / Placebo
|
0.3 units on a scale
Standard Deviation 0.98
|
0.09 units on a scale
Standard Deviation 0.29
|
|
Visual Analog Scales of Similarity to Alcohol 120 Minutes
Placebo / Cycloserine
|
0.57 units on a scale
Standard Deviation 0.87
|
0.29 units on a scale
Standard Deviation 0.62
|
|
Visual Analog Scales of Similarity to Alcohol 120 Minutes
Placebo / Placebo
|
0.10 units on a scale
Standard Deviation 0.30
|
0.33 units on a scale
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: 60 minutes prior to Glycine infusionPopulation: 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.
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Number of Drinks Felt Consumed at 60 Minutes Prior to Glycine Infusion
Placebo / Cycloserine
|
0.24 drinks felt consumed
Standard Deviation 0.54
|
0.75 drinks felt consumed
Standard Deviation 1.03
|
|
Number of Drinks Felt Consumed at 60 Minutes Prior to Glycine Infusion
Placebo / Placebo
|
0.05 drinks felt consumed
Standard Deviation 0.22
|
0.22 drinks felt consumed
Standard Deviation 0.52
|
|
Number of Drinks Felt Consumed at 60 Minutes Prior to Glycine Infusion
Glycine / Cycloserine
|
0.50 drinks felt consumed
Standard Deviation 1.34
|
0.70 drinks felt consumed
Standard Deviation 1.40
|
|
Number of Drinks Felt Consumed at 60 Minutes Prior to Glycine Infusion
Glycine / Placebo
|
0.30 drinks felt consumed
Standard Deviation 0.73
|
0.25 drinks felt consumed
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: 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.
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Number of Drinks Felt Consumed at 30 Minutes
Glycine / Cycloserine
|
0.38 Number of Drinks Felt Consumed
Standard Deviation 1.32
|
0.68 Number of Drinks Felt Consumed
Standard Deviation 1.00
|
|
Number of Drinks Felt Consumed at 30 Minutes
Glycine / Placebo
|
0.20 Number of Drinks Felt Consumed
Standard Deviation 0.62
|
0.13 Number of Drinks Felt Consumed
Standard Deviation 0.34
|
|
Number of Drinks Felt Consumed at 30 Minutes
Placebo / Cycloserine
|
0.38 Number of Drinks Felt Consumed
Standard Deviation 0.74
|
0.38 Number of Drinks Felt Consumed
Standard Deviation 1.10
|
|
Number of Drinks Felt Consumed at 30 Minutes
Placebo / Placebo
|
0.24 Number of Drinks Felt Consumed
Standard Deviation 0.77
|
0.04 Number of Drinks Felt Consumed
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: 60 minutesPopulation: 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.
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Number of Drinks Felt Consumed at 60 Minutes
Glycine / Cycloserine
|
0.05 Number of Drinks Felt Consumed
Standard Deviation 0.22
|
1.24 Number of Drinks Felt Consumed
Standard Deviation 1.73
|
|
Number of Drinks Felt Consumed at 60 Minutes
Glycine / Placebo
|
0.5 Number of Drinks Felt Consumed
Standard Deviation 1.1
|
0.4 Number of Drinks Felt Consumed
Standard Deviation 0.9
|
|
Number of Drinks Felt Consumed at 60 Minutes
Placebo / Cycloserine
|
0.86 Number of Drinks Felt Consumed
Standard Deviation 1.65
|
0.83 Number of Drinks Felt Consumed
Standard Deviation 1.47
|
|
Number of Drinks Felt Consumed at 60 Minutes
Placebo / Placebo
|
0.05 Number of Drinks Felt Consumed
Standard Deviation 0.22
|
0.2 Number of Drinks Felt Consumed
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: 120 minutesPopulation: 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.
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Number of Drinks Felt Consumed at 120 Minutes
Glycine / Placebo
|
0.1 Number of Drinks Felt Consumed
Standard Deviation 0.45
|
0.21 Number of Drinks Felt Consumed
Standard Deviation 0.83
|
|
Number of Drinks Felt Consumed at 120 Minutes
Placebo / Cycloserine
|
0.05 Number of Drinks Felt Consumed
Standard Deviation 0.22
|
0 Number of Drinks Felt Consumed
Standard Deviation 0
|
|
Number of Drinks Felt Consumed at 120 Minutes
Placebo / Placebo
|
0 Number of Drinks Felt Consumed
Standard Deviation 0
|
0.04 Number of Drinks Felt Consumed
Standard Deviation 0.2
|
|
Number of Drinks Felt Consumed at 120 Minutes
Glycine / Cycloserine
|
0 Number of Drinks Felt Consumed
Standard Deviation 0
|
0.13 Number of Drinks Felt Consumed
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - Baseline
Glycine / Cycloserine
|
3.41 units on a scale
Standard Deviation 5.76
|
1.91 units on a scale
Standard Deviation 3.19
|
|
Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - Baseline
Glycine / Placebo
|
3.3 units on a scale
Standard Deviation 6.51
|
2.75 units on a scale
Standard Deviation 3.77
|
|
Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - Baseline
Placebo / Cycloserine
|
3.57 units on a scale
Standard Deviation 6.71
|
1.83 units on a scale
Standard Deviation 3.38
|
|
Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - Baseline
Placebo / Placebo
|
5 units on a scale
Standard Deviation 9.2
|
1.88 units on a scale
Standard Deviation 3.58
|
SECONDARY outcome
Timeframe: 60 minutes prior to Glycine infusionPopulation: 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
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation 60 Minutes Prior to Glycine Infusion
Glycine / Cycloserine
|
6.23 units on a scale
Standard Deviation 10.32
|
7.39 units on a scale
Standard Deviation 6.97
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation 60 Minutes Prior to Glycine Infusion
Glycine / Placebo
|
6.6 units on a scale
Standard Deviation 9.68
|
3.79 units on a scale
Standard Deviation 4.72
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation 60 Minutes Prior to Glycine Infusion
Placebo / Cycloserine
|
7.24 units on a scale
Standard Deviation 11.05
|
6.25 units on a scale
Standard Deviation 7.88
|
|
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation 60 Minutes Prior to Glycine Infusion
Placebo / Placebo
|
4.57 units on a scale
Standard Deviation 8.64
|
3.67 units on a scale
Standard Deviation 5.37
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: 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
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 30 Minutes
Placebo / Cycloserine
|
5.2 units on a scale
Standard Deviation 8.45
|
7.04 units on a scale
Standard Deviation 10.66
|
|
Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 30 Minutes
Placebo / Placebo
|
4.62 units on a scale
Standard Deviation 8.23
|
3.58 units on a scale
Standard Deviation 4.83
|
|
Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 30 Minutes
Glycine / Cycloserine
|
7.14 units on a scale
Standard Deviation 12.01
|
10.05 units on a scale
Standard Deviation 10.06
|
|
Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 30 Minutes
Glycine / Placebo
|
5.8 units on a scale
Standard Deviation 10.56
|
5.87 units on a scale
Standard Deviation 7.95
|
SECONDARY outcome
Timeframe: 60 minutesPopulation: 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
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 60 Minutes
Glycine / Cycloserine
|
5.29 units on a scale
Standard Deviation 8.49
|
9.64 units on a scale
Standard Deviation 10.98
|
|
Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 60 Minutes
Glycine / Placebo
|
5.65 units on a scale
Standard Deviation 11.62
|
5.83 units on a scale
Standard Deviation 8.87
|
|
Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 60 Minutes
Placebo / Cycloserine
|
8.48 units on a scale
Standard Deviation 11.96
|
8.54 units on a scale
Standard Deviation 11.84
|
|
Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 60 Minutes
Placebo / Placebo
|
4.14 units on a scale
Standard Deviation 7.4
|
2.54 units on a scale
Standard Deviation 4.92
|
SECONDARY outcome
Timeframe: 120 minutesPopulation: 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
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 120 Minutes
Placebo / Cycloserine
|
4 units on a scale
Standard Deviation 7.36
|
3.04 units on a scale
Standard Deviation 4.69
|
|
Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 120 Minutes
Placebo / Placebo
|
3.71 units on a scale
Standard Deviation 7.72
|
1.25 units on a scale
Standard Deviation 2.82
|
|
Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 120 Minutes
Glycine / Cycloserine
|
3.57 units on a scale
Standard Deviation 7.02
|
4.13 units on a scale
Standard Deviation 7.21
|
|
Biphasic Alcohol Effects Scale (BAES) Subscale Sedation - 120 Minutes
Glycine / Placebo
|
4.35 units on a scale
Standard Deviation 8.56
|
1.67 units on a scale
Standard Deviation 3.31
|
SECONDARY outcome
Timeframe: BaselineVisual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Visual Analog Scales (VAS) - Baseline
Glycine / Cycloserine
|
0.32 units on a scale
Standard Deviation 0.78
|
0.22 units on a scale
Standard Deviation 0.85
|
|
Visual Analog Scales (VAS) - Baseline
Glycine / Placebo
|
0.5 units on a scale
Standard Deviation 1.4
|
0.22 units on a scale
Standard Deviation 0.85
|
|
Visual Analog Scales (VAS) - Baseline
Placebo / Cycloserine
|
0.76 units on a scale
Standard Deviation 1.64
|
0.25 units on a scale
Standard Deviation 0.90
|
|
Visual Analog Scales (VAS) - Baseline
Placebo / Placebo
|
0.48 units on a scale
Standard Deviation 0.98
|
0.25 units on a scale
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: 60 minutes prior to Glycine infusionVisual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Visual Analog Scales (VAS) - 60 Minutes Prior to Glycine Infusion
Glycine / Cycloserine
|
0.64 units on a scale
Standard Deviation 1.22
|
0.82 units on a scale
Standard Deviation 1.44
|
|
Visual Analog Scales (VAS) - 60 Minutes Prior to Glycine Infusion
Glycine / Placebo
|
0.68 units on a scale
Standard Deviation 1.20
|
0.33 units on a scale
Standard Deviation 0.92
|
|
Visual Analog Scales (VAS) - 60 Minutes Prior to Glycine Infusion
Placebo / Cycloserine
|
0.48 units on a scale
Standard Deviation 1.08
|
0.96 units on a scale
Standard Deviation 1.64
|
|
Visual Analog Scales (VAS) - 60 Minutes Prior to Glycine Infusion
Placebo / Placebo
|
0.38 units on a scale
Standard Deviation 0.97
|
0.61 units on a scale
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: 30 minutesVisual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Visual Analog Scales (VAS) - 30 Minutes
Placebo / Cycloserine
|
0.48 units on a scale
Standard Deviation 0.93
|
0.79 units on a scale
Standard Deviation 1.56
|
|
Visual Analog Scales (VAS) - 30 Minutes
Placebo / Placebo
|
0.52 units on a scale
Standard Deviation 1.03
|
0.25 units on a scale
Standard Deviation 0.90
|
|
Visual Analog Scales (VAS) - 30 Minutes
Glycine / Cycloserine
|
0.48 units on a scale
Standard Deviation 0.98
|
1.05 units on a scale
Standard Deviation 1.73
|
|
Visual Analog Scales (VAS) - 30 Minutes
Glycine / Placebo
|
0.65 units on a scale
Standard Deviation 1.09
|
0.30 units on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: 60 minutesVisual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Visual Analog Scales (VAS) - 60 Minutes
Glycine / Cycloserine
|
0.52 units on a scale
Standard Deviation 1.37
|
0.91 units on a scale
Standard Deviation 1.41
|
|
Visual Analog Scales (VAS) - 60 Minutes
Glycine / Placebo
|
0.8 units on a scale
Standard Deviation 1.58
|
0.22 units on a scale
Standard Deviation 0.67
|
|
Visual Analog Scales (VAS) - 60 Minutes
Placebo / Cycloserine
|
0.6 units on a scale
Standard Deviation 0.99
|
0.71 units on a scale
Standard Deviation 1.49
|
|
Visual Analog Scales (VAS) - 60 Minutes
Placebo / Placebo
|
0.19 units on a scale
Standard Deviation 0.40
|
0.17 units on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: 120 minutesVisual Analog Scales (VAS): Self-report rating scale used to measure high (0 not at all - 7 extremely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Visual Analog Scales (VAS) - 120 Minutes
Placebo / Placebo
|
0.24 units on a scale
Standard Deviation 0.54
|
0.25 units on a scale
Standard Deviation 0.90
|
|
Visual Analog Scales (VAS) - 120 Minutes
Glycine / Cycloserine
|
0.8 units on a scale
Standard Deviation 1.54
|
0.35 units on a scale
Standard Deviation 1.11
|
|
Visual Analog Scales (VAS) - 120 Minutes
Glycine / Placebo
|
0.55 units on a scale
Standard Deviation 1.05
|
0.21 units on a scale
Standard Deviation 0.83
|
|
Visual Analog Scales (VAS) - 120 Minutes
Placebo / Cycloserine
|
0.76 units on a scale
Standard Deviation 1.61
|
0.29 units on a scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: BaselineAlcohol 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)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink- Baseline
Glycine / Cycloserine
|
7.62 units on a scale
Standard Deviation 12.21
|
3.04 units on a scale
Standard Deviation 7.03
|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink- Baseline
Glycine / Placebo
|
9.5 units on a scale
Standard Deviation 17.01
|
2.5 units on a scale
Standard Deviation 7.37
|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink- Baseline
Placebo / Cycloserine
|
5 units on a scale
Standard Deviation 8.02
|
1.67 units on a scale
Standard Deviation 4.82
|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink- Baseline
Placebo / Placebo
|
7.62 units on a scale
Standard Deviation 10.91
|
0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 60 minutes prior to Glycine infusionAlcohol 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)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes Prior to Glycine Infusion
Glycine / Cycloserine
|
7.27 units on a scale
Standard Deviation 10.77
|
2.61 units on a scale
Standard Deviation 7.52
|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes Prior to Glycine Infusion
Glycine / Placebo
|
8.5 units on a scale
Standard Deviation 14.24
|
1.67 units on a scale
Standard Deviation 6.37
|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes Prior to Glycine Infusion
Placebo / Cycloserine
|
6.67 units on a scale
Standard Deviation 11.97
|
3.04 units on a scale
Standard Deviation 8.76
|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes Prior to Glycine Infusion
Placebo / Placebo
|
4.76 units on a scale
Standard Deviation 8.14
|
1.25 units on a scale
Standard Deviation 4.48
|
SECONDARY outcome
Timeframe: 30 minutesAlcohol 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)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink: - 30 Minutes
Glycine / Cycloserine
|
9.05 units on a scale
Standard Deviation 19.21
|
1.82 units on a scale
Standard Deviation 6.65
|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink: - 30 Minutes
Glycine / Placebo
|
9 units on a scale
Standard Deviation 14.83
|
2.17 units on a scale
Standard Deviation 7.36
|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink: - 30 Minutes
Placebo / Cycloserine
|
8 units on a scale
Standard Deviation 13.99
|
2.5 units on a scale
Standard Deviation 7.37
|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink: - 30 Minutes
Placebo / Placebo
|
5.71 units on a scale
Standard Deviation 10.28
|
2.08 units on a scale
Standard Deviation 6.58
|
SECONDARY outcome
Timeframe: 60 minutesAlcohol 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)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes
Glycine / Placebo
|
9 units on a scale
Standard Deviation 15.18
|
2.17 units on a scale
Standard Deviation 7.36
|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes
Placebo / Cycloserine
|
10.48 units on a scale
Standard Deviation 16.88
|
1.67 units on a scale
Standard Deviation 6.37
|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes
Placebo / Placebo
|
5.71 units on a scale
Standard Deviation 9.78
|
2.08 units on a scale
Standard Deviation 5.88
|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 60 Minutes
Glycine / Cycloserine
|
6.5 units on a scale
Standard Deviation 11.37
|
1.82 units on a scale
Standard Deviation 6.65
|
SECONDARY outcome
Timeframe: 120 minutesAlcohol 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)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 120 Minutes
Glycine / Cycloserine
|
6.19 units on a scale
Standard Deviation 10.71
|
1.30 units on a scale
Standard Deviation 4.58
|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 120 Minutes
Glycine / Placebo
|
8 units on a scale
Standard Deviation 13.99
|
1.667 units on a scale
Standard Deviation 4.82
|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 120 Minutes
Placebo / Cycloserine
|
9.05 units on a scale
Standard Deviation 14.8
|
2.08 units on a scale
Standard Deviation 6.58
|
|
Alcohol Craving Scale (ACS) Subscale: Desire to Drink - 120 Minutes
Placebo / Placebo
|
5.24 units on a scale
Standard Deviation 9.28
|
2.08 units on a scale
Standard Deviation 6.58
|
SECONDARY outcome
Timeframe: BaselineAlcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - Baseline
Glycine / Cycloserine
|
6.67 units on a scale
Standard Deviation 11.55
|
1.74 units on a scale
Standard Deviation 4.91
|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - Baseline
Glycine / Placebo
|
10.5 units on a scale
Standard Deviation 16.69
|
0.42 units on a scale
Standard Deviation 2.04
|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - Baseline
Placebo / Cycloserine
|
6.82 units on a scale
Standard Deviation 12.87
|
0.42 units on a scale
Standard Deviation 2.01
|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - Baseline
Placebo / Placebo
|
8.10 units on a scale
Standard Deviation 13.65
|
0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 60 minutes prior to Glycine infusionAlcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes Prior to Glycine Infusion
Glycine / Placebo
|
8 units on a scale
Standard Deviation 11.97
|
0.83 units on a scale
Standard Deviation 4.08
|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes Prior to Glycine Infusion
Placebo / Cycloserine
|
7.62 units on a scale
Standard Deviation 11.79
|
1.30 units on a scale
Standard Deviation 4.58
|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes Prior to Glycine Infusion
Placebo / Placebo
|
6.19 units on a scale
Standard Deviation 10.71
|
0.42 units on a scale
Standard Deviation 2.04
|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes Prior to Glycine Infusion
Glycine / Cycloserine
|
7.73 units on a scale
Standard Deviation 14.78
|
0.87 units on a scale
Standard Deviation 2.88
|
SECONDARY outcome
Timeframe: 30 minutesAlcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 30 Minutes
Glycine / Cycloserine
|
11.43 units on a scale
Standard Deviation 22.2
|
0.91 units on a scale
Standard Deviation 4.26
|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 30 Minutes
Glycine / Placebo
|
8 units on a scale
Standard Deviation 12.81
|
0.87 units on a scale
Standard Deviation 4.17
|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 30 Minutes
Placebo / Cycloserine
|
10.5 units on a scale
Standard Deviation 14.68
|
0.42 units on a scale
Standard Deviation 2.04
|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 30 Minutes
Placebo / Placebo
|
6.67 units on a scale
Standard Deviation 10.17
|
0.42 units on a scale
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: 60 minutesAlcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes
Glycine / Cycloserine
|
5.5 units on a scale
Standard Deviation 9.45
|
0.46 units on a scale
Standard Deviation 2.13
|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes
Glycine / Placebo
|
8.5 units on a scale
Standard Deviation 13.87
|
0.87 units on a scale
Standard Deviation 4.17
|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes
Placebo / Cycloserine
|
8.1 units on a scale
Standard Deviation 12.5
|
0.83 units on a scale
Standard Deviation 2.82
|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 60 Minutes
Placebo / Placebo
|
6.67 units on a scale
Standard Deviation 11.97
|
0.83 units on a scale
Standard Deviation 4.08
|
SECONDARY outcome
Timeframe: 120 minutesAlcohol Craving Scale (ACS) Subscale: Mood improvement : Self-report rating scale used to measure expected alcohol-related mood improvement (0 Not at all - 100 Definitely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 120 Minutes
Glycine / Cycloserine
|
6.19 units on a scale
Standard Deviation 11.61
|
0.87 units on a scale
Standard Deviation 2.88
|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 120 Minutes
Glycine / Placebo
|
7 units on a scale
Standard Deviation 11.74
|
0.83 units on a scale
Standard Deviation 4.08
|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 120 Minutes
Placebo / Cycloserine
|
8.57 units on a scale
Standard Deviation 14.24
|
0.42 units on a scale
Standard Deviation 2.04
|
|
Alcohol Craving Scale (ACS) Subscale: Mood Improvement - 120 Minutes
Placebo / Placebo
|
7.62 units on a scale
Standard Deviation 14.11
|
0.42 units on a scale
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: BaselineAlcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - Baseline
Glycine / Placebo
|
12.5 units on a scale
Standard Deviation 18.6
|
1.67 units on a scale
Standard Deviation 5.65
|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - Baseline
Placebo / Cycloserine
|
7.73 units on a scale
Standard Deviation 13.78
|
0.42 units on a scale
Standard Deviation 2.04
|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - Baseline
Placebo / Placebo
|
8.10 units on a scale
Standard Deviation 13.65
|
0.42 units on a scale
Standard Deviation 2.04
|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - Baseline
Glycine / Cycloserine
|
8.1 units on a scale
Standard Deviation 15.04
|
2.61 units on a scale
Standard Deviation 6.19
|
SECONDARY outcome
Timeframe: 60 minutes prior to Glycine infusionAlcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes Prior to Glycine Infusion
Glycine / Cycloserine
|
6.36 units on a scale
Standard Deviation 11.36
|
1.30 units on a scale
Standard Deviation 4.58
|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes Prior to Glycine Infusion
Glycine / Placebo
|
8.95 units on a scale
Standard Deviation 13.29
|
1.25 units on a scale
Standard Deviation 4.48
|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes Prior to Glycine Infusion
Placebo / Placebo
|
10.48 units on a scale
Standard Deviation 15.65
|
0.42 units on a scale
Standard Deviation 2.04
|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes Prior to Glycine Infusion
Placebo / Cycloserine
|
7.14 units on a scale
Standard Deviation 11.02
|
0.44 units on a scale
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: 30 minutesAlcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - 30 Minutes
Glycine / Cycloserine
|
12.38 units on a scale
Standard Deviation 20.47
|
1.82 units on a scale
Standard Deviation 5.89
|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - 30 Minutes
Glycine / Placebo
|
8.95 units on a scale
Standard Deviation 13.29
|
1.74 units on a scale
Standard Deviation 5.76
|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - 30 Minutes
Placebo / Cycloserine
|
9.5 units on a scale
Standard Deviation 13.56
|
0.42 units on a scale
Standard Deviation 2.04
|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - 30 Minutes
Placebo / Placebo
|
8.57 units on a scale
Standard Deviation 11.95
|
0.42 units on a scale
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: 60 minutesAlcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes
Placebo / Placebo
|
6.19 units on a scale
Standard Deviation 10.71
|
0.83 units on a scale
Standard Deviation 4.08
|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes
Glycine / Cycloserine
|
6.5 units on a scale
Standard Deviation 11.82
|
1.36 units on a scale
Standard Deviation 4.68
|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes
Glycine / Placebo
|
10.5 units on a scale
Standard Deviation 16.70
|
1.74 units on a scale
Standard Deviation 5.76
|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - 60 Minutes
Placebo / Cycloserine
|
9.05 units on a scale
Standard Deviation 15.46
|
0.42 units on a scale
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: 120 minutesAlcohol Craving Scale (ACS) Subscale: Discomfort: Self-report rating scale - subscale reflecting expected alcohol-related relief from discomfort (0 Not at all - 100 Definitely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - 120 Minutes
Glycine / Cycloserine
|
8.57 units on a scale
Standard Deviation 13.52
|
1.14 units on a scale
Standard Deviation 4.91
|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - 120 Minutes
Glycine / Placebo
|
9.5 units on a scale
Standard Deviation 15.38
|
1.67 units on a scale
Standard Deviation 5.65
|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - 120 Minutes
Placebo / Cycloserine
|
9.05 units on a scale
Standard Deviation 15.78
|
0.42 units on a scale
Standard Deviation 2.04
|
|
Alcohol Craving Scale (ACS) Subscale: Discomfort - 120 Minutes
Placebo / Placebo
|
6.19 units on a scale
Standard Deviation 11.17
|
0.83 units on a scale
Standard Deviation 4.08
|
SECONDARY outcome
Timeframe: BaselineAlcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - Baseline
Glycine / Cycloserine
|
29.05 units on a scale
Standard Deviation 36.59
|
93.48 units on a scale
Standard Deviation 21.24
|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - Baseline
Glycine / Placebo
|
35.5 units on a scale
Standard Deviation 40.32
|
94.58 units on a scale
Standard Deviation 20.64
|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - Baseline
Placebo / Cycloserine
|
42.27 units on a scale
Standard Deviation 42.64
|
99.17 units on a scale
Standard Deviation 4.08
|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - Baseline
Placebo / Placebo
|
41.43 units on a scale
Standard Deviation 40.29
|
98.75 units on a scale
Standard Deviation 4.48
|
SECONDARY outcome
Timeframe: 60 minutes prior to Glycine infusionAlcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes Prior to Glycine Infusion
Glycine / Placebo
|
40.5 units on a scale
Standard Deviation 42.49
|
95 units on a scale
Standard Deviation 20.64
|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes Prior to Glycine Infusion
Placebo / Cycloserine
|
36.67 units on a scale
Standard Deviation 41.51
|
99.13 units on a scale
Standard Deviation 4.17
|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes Prior to Glycine Infusion
Placebo / Placebo
|
42.86 units on a scale
Standard Deviation 42.33
|
99.17 units on a scale
Standard Deviation 4.08
|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes Prior to Glycine Infusion
Glycine / Cycloserine
|
30.46 units on a scale
Standard Deviation 37.48
|
98.26 units on a scale
Standard Deviation 4.91
|
SECONDARY outcome
Timeframe: 30 minutesAlcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 30 Minutes
Glycine / Cycloserine
|
32.86 units on a scale
Standard Deviation 40.27
|
99.1 units on a scale
Standard Deviation 4.26
|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 30 Minutes
Glycine / Placebo
|
36 units on a scale
Standard Deviation 40.18
|
98.70 units on a scale
Standard Deviation 6.26
|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 30 Minutes
Placebo / Cycloserine
|
36.5 units on a scale
Standard Deviation 40.56
|
99.17 units on a scale
Standard Deviation 4.08
|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 30 Minutes
Placebo / Placebo
|
36.67 units on a scale
Standard Deviation 37.59
|
99.17 units on a scale
Standard Deviation 4.08
|
SECONDARY outcome
Timeframe: 60 minutesAlcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes
Glycine / Cycloserine
|
34 units on a scale
Standard Deviation 42.23
|
99.1 units on a scale
Standard Deviation 4.26
|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes
Placebo / Cycloserine
|
25.71 units on a scale
Standard Deviation 35.3
|
99.17 units on a scale
Standard Deviation 4.08
|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes
Placebo / Placebo
|
37.14 units on a scale
Standard Deviation 40.52
|
99.17 units on a scale
Standard Deviation 4.08
|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 60 Minutes
Glycine / Placebo
|
39.5 units on a scale
Standard Deviation 43.34
|
99.13 units on a scale
Standard Deviation 4.17
|
SECONDARY outcome
Timeframe: 120 minutesAlcohol Craving Scale (ACS) Subscale: Self-report rating scale used to measure reduced control of alcohol (0 Not at all - 100 Definitely)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 120 Minutes
Glycine / Cycloserine
|
34.29 units on a scale
Standard Deviation 40.94
|
98.26 units on a scale
Standard Deviation 4.91
|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 120 Minutes
Glycine / Placebo
|
33.5 units on a scale
Standard Deviation 42.83
|
99.17 units on a scale
Standard Deviation 4.08
|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 120 Minutes
Placebo / Cycloserine
|
30.48 units on a scale
Standard Deviation 39.05
|
99.17 units on a scale
Standard Deviation 4.08
|
|
Alcohol Craving Scale (ACS) Subscale: Reduced Control of Alcohol Use - 120 Minutes
Placebo / Placebo
|
36.67 units on a scale
Standard Deviation 40.17
|
99.17 units on a scale
Standard Deviation 4.08
|
SECONDARY outcome
Timeframe: 30 minutesgordon 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)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Continuous Performance Task (CPT) - Distractibility A-Prime - 30 Minutes
Placebo / Cycloserine
|
0.90 units on a scale
Standard Deviation 0.15
|
0.1 units on a scale
Standard Deviation 0.01
|
|
Continuous Performance Task (CPT) - Distractibility A-Prime - 30 Minutes
Placebo / Placebo
|
0.96 units on a scale
Standard Deviation 0.05
|
0.1 units on a scale
Standard Deviation 0.01
|
|
Continuous Performance Task (CPT) - Distractibility A-Prime - 30 Minutes
Glycine / Cycloserine
|
0.93 units on a scale
Standard Deviation 0.14
|
0.1 units on a scale
Standard Deviation 0.01
|
|
Continuous Performance Task (CPT) - Distractibility A-Prime - 30 Minutes
Glycine / Placebo
|
0.97 units on a scale
Standard Deviation 0.05
|
0.1 units on a scale
Standard Deviation 0.01
|
SECONDARY outcome
Timeframe: 30 minutesgordon 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)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Continuous Performance Task (CPT) - Vigilance - A-Prime Score 30 Minutes
Glycine / Cycloserine
|
0.98 units on a scale
Standard Deviation 0.03
|
0.1 units on a scale
Standard Deviation 0.01
|
|
Continuous Performance Task (CPT) - Vigilance - A-Prime Score 30 Minutes
Glycine / Placebo
|
0.1 units on a scale
Standard Deviation 0.01
|
0.1 units on a scale
Standard Deviation 0.02
|
|
Continuous Performance Task (CPT) - Vigilance - A-Prime Score 30 Minutes
Placebo / Cycloserine
|
0.1 units on a scale
Standard Deviation 0.02
|
0.1 units on a scale
Standard Deviation 0.01
|
|
Continuous Performance Task (CPT) - Vigilance - A-Prime Score 30 Minutes
Placebo / Placebo
|
0.99 units on a scale
Standard Deviation 0.02
|
0.1 units on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 60 minutes - Trial 1Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 No words recalled - 12 all words recalled)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 1
Placebo / Cycloserine
|
5.48 units on a scale
Standard Deviation 1.12
|
7.75 units on a scale
Standard Deviation 1.82
|
|
Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 1
Glycine / Cycloserine
|
5.29 units on a scale
Standard Deviation 1.93
|
7.09 units on a scale
Standard Deviation 1.81
|
|
Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 1
Glycine / Placebo
|
6.05 units on a scale
Standard Deviation 1.91
|
8.52 units on a scale
Standard Deviation 1.95
|
|
Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 1
Placebo / Placebo
|
5.95 units on a scale
Standard Deviation 1.66
|
8.2 units on a scale
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: 60 minutes - Trial 2Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 No words recalled - 12 all words recalled)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 2
Glycine / Placebo
|
8.45 units on a scale
Standard Deviation 1.96
|
11.09 units on a scale
Standard Deviation 1.20
|
|
Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 2
Placebo / Cycloserine
|
7.1 units on a scale
Standard Deviation 1.67
|
10.5 units on a scale
Standard Deviation 1.18
|
|
Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 2
Placebo / Placebo
|
8.67 units on a scale
Standard Deviation 1.83
|
10.96 units on a scale
Standard Deviation 1.37
|
|
Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 2
Glycine / Cycloserine
|
7.67 units on a scale
Standard Deviation 2.08
|
10.09 units on a scale
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: 60 minutes - Trial 3Hopkins Verbal Learning Task (HVLT) - measures verbal memory and hippocampus function. (Three immediate recall trials) (0 No words recalled - 12 all words recalled)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 3
Glycine / Cycloserine
|
8 units on a scale
Standard Deviation 2.47
|
10.57 units on a scale
Standard Deviation 1.59
|
|
Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 3
Glycine / Placebo
|
9.2 units on a scale
Standard Deviation 2.14
|
11.48 units on a scale
Standard Deviation 0.85
|
|
Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 3
Placebo / Cycloserine
|
8.48 units on a scale
Standard Deviation 2.02
|
11.17 units on a scale
Standard Deviation 0.82
|
|
Hopkins Verbal Learning Task - Immediate Recall - 60 Minutes - Trial 3
Placebo / Placebo
|
9.24 units on a scale
Standard Deviation 1.64
|
11.67 units on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: 90 minutesHopkins 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)
Outcome measures
| Measure |
Alcoholic Subjects
n=20 Participants
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
|
Healthy Subjects
n=22 Participants
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.
|
|---|---|---|
|
Hopkins Verbal Learning Task - Delay Recall - 90 Minutes
Placebo / Cycloserine
|
6.29 units on a scale
Standard Deviation 2.78
|
10.21 units on a scale
Standard Deviation 1.74
|
|
Hopkins Verbal Learning Task - Delay Recall - 90 Minutes
Placebo / Placebo
|
8.25 units on a scale
Standard Deviation 2.43
|
11.38 units on a scale
Standard Deviation 1.28
|
|
Hopkins Verbal Learning Task - Delay Recall - 90 Minutes
Glycine / Cycloserine
|
5.1 units on a scale
Standard Deviation 3.43
|
9.7 units on a scale
Standard Deviation 2.44
|
|
Hopkins Verbal Learning Task - Delay Recall - 90 Minutes
Glycine / Placebo
|
7.75 units on a scale
Standard Deviation 2.4
|
10.87 units on a scale
Standard Deviation 1.39
|
Adverse Events
Alcoholic Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place