N/A N=73 Randomized Double-blind Health Services Research

GABA Mechanisms Underlying the Vulnerability to Alcohol Dependence

Alcoholism

Bottom Line

View on ClinicalTrials.gov: NCT00611767 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: Visual Analog Scales of Similarity to Alcohol - Baseline — 0; 0; 0; 0 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Thiopental (Drug); Placebo (Drug)
Age: Adult · 21+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Apr 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Analog Scales of Similarity to Alcohol - Baseline	0; 0; 0; 0	—
PRIMARY Visual Analog Scales of Similarity to Alcohol - 15 Minutes	3.23; 2.35; 0.04; 0.17	—
PRIMARY Visual Analog Scales of Similarity to Alcohol - 45 Minutes	2.91; 1.87; 0.04; 0.04	—
PRIMARY Visual Analog Scales of Similarity to Alcohol - 80 Minutes	0.84; 0.50; 0.04; 0	—
PRIMARY Visual Analog Scales of Similarity to Alcohol - 110 Minutes	0.35; 0.22; 0.11; 0	—
PRIMARY Visual Analog Scales of Similarity to Alcohol - 170 Minutes	0.02; 0; 0.02; 0	—
PRIMARY Visual Analog Scales of Similarity to Alcohol - 230 Minutes	0; 0; 0; 0	—
SECONDARY Number of Drinks Felt Consumed at Baseline	0; 0; 0; 0	—
SECONDARY Number of Drinks Felt Consumed - 15 Minutes	3.28; 3.22; 0.11; 0.17	—
SECONDARY Number of Drinks Felt Consumed - 45 Minutes	3; 2.91; 0.03; 0.04	—
SECONDARY Number of Drinks Felt Consumed - 80 Minutes	1.14; 0.96; 0.04; 0	—
SECONDARY Number of Drinks Felt Consumed - 110 Minutes	0.35; 0.22; 0.04; 0	—
SECONDARY Number of Drinks Felt Consumed - 170 Minutes	0; 0; 0.02; 0	—
SECONDARY Number of Drinks Felt Consumed - 230 Minutes	0; 0; 0; 0	—
SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline	1.86; 1.22; 2.74; 1.91	—
SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 15 Minutes	5.26; 3.87; 1.5; 1.87	—
SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 45 Minutes	2.33; 2.70; 1.13; 1.57	—
SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 80 Minutes	1.37; 1.78; 1.5; 1.35	—
SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant- 110 Minutes	1.12; 1.52; 1.44; 1.91	—
SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes	0.98; 1.39; 1.85; 1.65	—
SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 230 Minutes	1; 2.30; 1.72; 2.04	—
SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline	1.49; 0.48; 1.20; 0.44	—
SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 15 Minutes	16.07; 6.74; 1.41; 2.04	—
SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 45 Minutes	15.83; 9.30; 1.70; 1.17	—
SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 80 Minutes	7.98; 3.48; 0.94; 0.74	—
SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes	2.37; 1.61; 0.63; 0.78	—
SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes	0.83; 0.52; 0.26; 0.44	—
SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes	0.45; 0.22; 0.15; 0.26	—
SECONDARY Visual Analog Scales (VAS) - High - Baseline	0; 0; 0; 0	—
SECONDARY Visual Analog Scales (VAS) - High - 15 Minutes	2.35; 1.74; 0; 0	—
SECONDARY Visual Analog Scales (VAS) - High - 45 Minutes	1.69; 1.26; 0; 0	—
SECONDARY Visual Analog Scales (VAS) - High - 80 Minutes	0.40; 0.61; 0.02; 0	—
SECONDARY Visual Analog Scales (VAS) - High - 110 Minutes	0.14; 0.13; 0; 0	—
SECONDARY Visual Analog Scales (VAS) - High - 170 Minutes	0; 0; 0; 0	—
SECONDARY Visual Analog Scales (VAS) - High - 230 Minutes	0; 0; 0; 0	—
SECONDARY Visual Analog Scales (VAS) - Buzzed - Baseline	0; 0; 0; 0	—
SECONDARY Visual Analog Scales (VAS) - Buzzed - 15 Minutes	2.07; 1.65; 0; 0.04	—
SECONDARY Visual Analog Scales (VAS) - Buzzed - 45 Minutes	1.74; 1.26; 0; 0.04	—
SECONDARY Visual Analog Scales (VAS) - Buzzed - 80 Minutes	0.21; 0.52; 0.04; 0	—
SECONDARY Visual Analog Scales (VAS) - Buzzed - 110 Minutes	0.02; 0.13; 0.02; 0	—
SECONDARY Visual Analog Scales (VAS) - Buzzed - 170 Minutes	0.02; 0; 0; 0	—
SECONDARY Visual Analog Scales (VAS) - Buzzed - 230 Minutes	0; 0; 0; 0	—
SECONDARY Visual Analog Scales (VAS) - Drowsy - Baseline	0.61; 0.52; 0.22; 0.48	—
SECONDARY Visual Analog Scales (VAS) - Drowsy - 15 Minutes	2.86; 1.74; 0.39; 0.35	—
SECONDARY Visual Analog Scales (VAS) - Drowsy - 45 Minutes	3.02; 2.74; 0.44; 0.39	—
SECONDARY Visual Analog Scales (VAS) - Drowsy - 80 Minutes	2.14; 1.48; 0.20; 0.35	—
SECONDARY Visual Analog Scales (VAS) - Drowsy - 110 Minutes	1.19; 1.13; 0.13; 0.30	—
SECONDARY Visual Analog Scales (VAS) - Drowsy - 170 Minutes	0.38; 0.26; 0.15; 0.22	—
SECONDARY Visual Analog Scales (VAS) - Drowsy - 230 Minutes	0.31; 0.13; 0.11; 0.17	—
SECONDARY Visual Analog Scales (VAS) - Depressed - Baseline	0.07; 0.04; 0; 0	—
SECONDARY Visual Analog Scales (VAS) - Depressed - 15 Minutes	0.02; 0.13; 0.04; 0	—
SECONDARY Visual Analog Scales (VAS) - Depressed - 45 Minutes	0.02; 0.09; 0.04; 0	—
SECONDARY Visual Analog Scales (VAS) - Depressed - 80 Minutes	0.02; 0.04; 0; 0	—
SECONDARY Visual Analog Scales (VAS) - Depressed - 110 Minutes	0; 0; 0; 0	—
SECONDARY Visual Analog Scales (VAS) - Depressed - 170 Minutes	0; 0; 0; 0	—
SECONDARY Visual Analog Scales (VAS) - Depressed - 230 Minutes	0.02; 0; 0; 0	—
SECONDARY Visual Analog Scales (VAS) - Anxious - Baseline	0.12; 0.13; 0.09; 0.13	—
SECONDARY Visual Analog Scales (VAS) - Anxious - 15 Minutes	0.21; 0.22; 0; 0.04	—
SECONDARY Visual Analog Scales (VAS) - Anxious - 45 Minutes	0.07; 0.13; 0; 0	—
SECONDARY Visual Analog Scales (VAS) - Anxious - 80 Minutes	0.05; 0; 0; 0.04	—
SECONDARY Visual Analog Scales (VAS) - Anxious - 110 Minutes	0; 0; 0.02; 0	—
SECONDARY Visual Analog Scales (VAS) - Anxious - 170 Minutes	0; 0; 0.04; 0.04	—
SECONDARY Visual Analog Scales (VAS) - Anxious - 230 Minutes	0; 0.04; 0; 0.04	—
SECONDARY Clinician Administered Dissociative Symptoms Scale - Patient Rated - Baseline	0; 0; 0; 0	—
SECONDARY Clinician Administered Dissociative Symptoms Scale - Patient Rated - 15 Minutes	2.57; 1.74; 0.02; 0.04	—
SECONDARY Clinician Administered Dissociative Symptoms Scale - Patient Rated - 80 Minutes	0.73; 0.83; 0; 0	—
SECONDARY Clinician Administered Dissociative Symptoms Scale - Patient Rated - 110 Minutes	0.43; 0.22; 0; 0	—
SECONDARY Clinician Administered Dissociative Symptoms Scale - Clinician Rated - Baseline	0.02; 0; 0; 0	—
SECONDARY Clinician Administered Dissociative Symptoms Scale - Clinician Rated - 15 Minutes	1.43; 1.04; 0.02; 0	—
SECONDARY Clinician Administered Dissociative Symptoms Scale - Clinician Rated - 80 Minutes	0.68; 0.35; 0; 0.09	—
SECONDARY Clinician Administered Dissociative Symptoms Scale - Clinician Rated - 110 Minutes	0.21; 0.17; 0; 0	—
SECONDARY Pegboard Task - Baseline (Dominant Hand)	58.49; 60.57; 57.37; 60.78	—
SECONDARY Pegboard Task - 15 Minutes (Dominant Hand)	84.56; 82.04; 65.11; 69.61	—
SECONDARY Pegboard Task - Baseline (Non-Dominant Hand)	64.19; 66.52; 62.98; 69.83	—
SECONDARY Pegboard Task - 15 Minutes (Non-Dominant Hand)	91.19; 87.09; 71.13; 75.48	—
SECONDARY Hopkins Verbal Learning Task (HVLT) - Total Recall	25.88; 26.96; 29.02; 29.35	—
SECONDARY Hopkins Verbal Learning Task (HVLT) - Delayed Recall	8.29; 8.74; 10.44; 10.04	—
SECONDARY Verbal Fluency	13.47; 13.96; 14.35; 14.04	—

Summary

This Project will explore the hypothesis that individuals with a family history positive for alcohol dependence (without any current Axis I disorder, except nicotine dependence), experience an alteration in the reward "valence" (balance of positive and negative effects) of the GABAA receptor agonist barbiturate (thiopental) compared to family history negative age-matched subjects. Further, variation in genes involved in brain GABA function may influence the risk for alcoholism by altering a component of the discriminative stimulus effects of ethanol.

Eligibility Criteria

Inclusion Criteria

Male and female between the ages of 21 and 30 years
medically and neurologically healthy on the basis of history, physical examination, Electrocardiogram (EKG), screening laboratories
absence of any evidence of substance abuse (with the exception of nicotine dependence) on the basis of history and drug and ethanol-free at the time of testing based on urine toxicology and breath alcohol levels at screening and on each test day.

Exclusion Criteria

Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) Axis I psychiatric and substance abuse or dependence diagnosis by history on psychiatric evaluation that includes a structured diagnostic interview (SCID)
unwillingness to remain alcohol-free for three days prior to each test day;
for women, positive pregnancy test at screening or intention to engage in unprotected sex during the study and
alcohol naive. For Family History Positive Subjects: 1) Biological father and another first or second-degree biological relative with history of alcoholism by Family History Assessment Module (FHAM) developed by The Collaborative Study on the Genetics of Alcoholism (COGA).

For Family History Negative Subjects: NO family history of alcoholism in any first or second-degree relatives. Subjects must reliably report on three first-degree relatives.

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Data sourced from ClinicalTrials.gov (NCT00611767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.