N/A
N=180
Intravenous Alcohol Administration Using BrAc Method in Healthy Subjects With and Without a Family History of Alcoholism
Alcoholism
Bottom Line
View on ClinicalTrials.gov: NCT00612352 ↗Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Number of Drinks Felt Consumed at Baseline — 0; 0; 0; 0 drinks felt consumed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ethanol High Dose, Ethanol Low Dose, and Placebo (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Drinks Felt Consumed at Baseline |
0; 0; 0; 0; 0; 0.04 | — |
| PRIMARY Number of Drinks Felt Consumed at 10 Minutes |
0.07; 0.08; 0.49; 0.7; 0.76; 1.15 | — |
| PRIMARY Number of Drinks Felt Consumed at 30 Minutes |
0.2; 0.27; 1.88; 2.03; 3.65; 3.86 | — |
| PRIMARY Number of Drinks Felt Consumed at 110 Minutes |
0.1; 0.09; 0.97; 1.2; 3.22; 3.64 | — |
| PRIMARY Number of Drinks Felt Consumed at 140 Minutes |
0.03; 0.04; 0.33; 0.46; 2.12; 2.53 | — |
| PRIMARY Number of Drinks Felt Consumed at 170 Minutes |
0; 0; 0.07; 0.11; 1.19; 1.39 | — |
| PRIMARY Number of Drinks Felt Consumed at 230 Minutes |
0; 0; 0.03; 0.03; 0.37; 0.55 | — |
| PRIMARY Visual Analog Scale of Similarity to Alcohol - Baseline |
0.08; 0.13; 0.1; 0.1; 0.02; 0.1 | — |
| PRIMARY Visual Analog Scale of Similarity to Alcohol -10 Minutes |
0.16; 0.12; 0.76; 1.13; 1.59; 1.56 | — |
| PRIMARY Visual Analog Scale of Similarity to Alcohol - 30 Minutes |
0.36; 0.33; 2.05; 2.62; 3.82; 3.98 | — |
| PRIMARY Visual Analog Scale of Similarity to Alcohol - 60 Minutes |
0.36; 0.32; 2.21; 2.52; 3.83; 4.01 | — |
| PRIMARY Visual Analog Scale of Similarity to Alcohol - 110 Minutes |
0.1; 0.14; 1.19; 1.31; 2.97; 3.12 | — |
| PRIMARY Visual Analog Scale of Similarity to Alcohol - 140 Minutes |
0.05; 0.05; 0.29; 0.68; 2.29; 2.16 | — |
| PRIMARY Visual Analog Scale of Similarity to Alcohol - 170 Minutes |
0; 0.01; 0.1; 0.21; 1.37; 1.41 | — |
| PRIMARY Visual Analog Scale of Similarity to Alcohol - 230 Minutes |
0.02; 0; 0.05; 0.05; 0.46; 0.71 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative Baseline |
2.21; 1.8; 1.16; 2.21; 2.02; 2.17 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 10 Minutes |
2.04; 1.85; 1.59; 3.83; 4.3; 4.5 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 30 Minutes |
2.1; 2.36; 3.41; 6.16; 7.75; 9.38 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 60 Minutes |
2.46; 2.9; 4.17; 6.32; 8.27; 10.45 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 110 Minutes |
1.93; 1.92; 4.21; 4.68; 7.5; 9.77 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 140 Minutes |
1.34; 1.8; 2.55; 3.39; 6.28; 7.4 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 170 Minutes |
0.79; 1.22; 1.4; 1.96; 3.97; 5.78 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Sedative - 230 Minutes |
0.62; 1.03; 1.28; 1.56; 2.7; 3.25 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - Baseline |
3.15; 2.93; 4.59; 4.47; 3.4; 3.55 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 10 Minutes |
3.39; 2.19; 4.23; 3.54; 3.83; 4.19 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 30 Minutes |
3.75; 2.79; 5.66; 6.19; 8.97; 10.38 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 60 Minutes |
3.75; 2.74; 4.29; 4.82; 7.51; 7.61 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 110 Minutes |
3.15; 3.92; 2.83; 3.62; 3; 4.52 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 140 Minutes |
3.12; 3.79; 2.79; 3.3; 2.35; 3.79 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 170 Minutes |
3.57; 4.1; 2.76; 3.21; 1.63; 3.22 | — |
| SECONDARY Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulant - 240 Minutes |
4.77; 3.91; 2.95; 4.27; 1.36; 2.79 | — |
| SECONDARY Visual Analog Scale (VAS) HIGH - Baseline |
0.08; 0.17; 0.09; 0.18; 0.05; 0.11 | — |
| SECONDARY Visual Analog Scale (VAS) HIGH - 10 Minutes |
0.11; 0.12; 0.25; 0.32; 0.51; 0.52 | — |
| SECONDARY Visual Analog Scale (VAS) HIGH - 30 Minutes |
0.18; 0.16; 0.59; 0.99; 1.83; 1.73 | — |
| SECONDARY Visual Analog Scale (VAS) HIGH - 60 Minutes |
0.18; 0.19; 0.69; 0.9; 1.73; 1.66 | — |
| SECONDARY Visual Analog Scale (VAS) HIGH - 110 Minutes |
0.05; 0.08; 0.29; 0.47; 1.21; 0.96 | — |
| SECONDARY Visual Analog Scale (VAS) HIGH - 140 Minutes |
0; 0.05; 0.07; 0.21; 0.85; 0.68 | — |
| SECONDARY Visual Analog Scale (VAS) HIGH - 170 Minutes |
0.02; 0.04; 0.02; 0.06; 0.46; 0.46 | — |
| SECONDARY Visual Analog Scale (VAS) HIGH - 240 Minutes |
0.02; 0.04; 0; 0.03; 0.05; 0.16 | — |
| SECONDARY Visual Analog Scale (VAS) Drowsy - Baseline |
0.61; 0.7; 0.47; 0.71; 0.62; 0.87 | — |
| SECONDARY Visual Analog Scale (VAS) Drowsy - 10 Minutes |
0.63; 0.52; 0.47; 0.77; 0.87; 0.96 | — |
| SECONDARY Visual Analog Scale (VAS) Drowsy - 30 Minutes |
0.53; 0.51; 0.71; 1.03; 1.18; 1.05 | — |
| SECONDARY Visual Analog Scale (VAS) Drowsy - 60 Minutes |
0.74; 0.69; 1.03; 1.13; 1.14; 1.27 | — |
| SECONDARY Visual Analog Scale (VAS) Drowsy - 110 Minutes |
0.51; 0.56; 0.95; 0.98; 1.38; 1.73 | — |
| SECONDARY Visual Analog Scale (VAS) Drowsy - 140 Minutes |
0.46; 0.45; 0.41; 0.9; 1.35; 1.60 | — |
| SECONDARY Visual Analog Scale (VAS) Drowsy - 170 Minutes |
0.16; 0.24; 0.26; 0.61; 0.93; 1.16 | — |
| SECONDARY Visual Analog Scale (VAS) Drowsy - 230 Minutes |
0.15; 0.21; 0.29; 0.35; 0.59; 0.8 | — |
| SECONDARY Hopkins Verbal Learning Task - Immediate Recall - Trial 1 |
7.26; 7.46; 7.26; 7.17; 6.33; 6.27 | — |
| SECONDARY Hopkins Verbal Learning Task - Immediate Recall - Trial 2 |
9.43; 9.7; 8.95; 9.13; 7.78; 8.11 | — |
| SECONDARY Hopkins Verbal Learning Task - Immediate Recall - Trial 3 |
10.8; 10.69; 10.22; 10.28; 9.05; 8.89 | — |
| SECONDARY Hopkins Verbal Learning Task - Delay Recall |
10.48; 10.08; 9.41; 9.43; 7.08; 6.796 | — |
| SECONDARY Pegboard Task - Baseline (Dominant Hand) |
63.64; 61.58; 63.12; 62.4; 64.07; 63.4 | — |
| SECONDARY Pegboard Task - 30 Minutes (Dominant Hand) |
68.32; 65.05; 67.12; 67.26; 76.92; 76.74 | — |
| SECONDARY Pegboard Task - Baseline (Non-Dominant Hand) |
69.36; 66.85; 70.19; 67.87; 70.66; 67.16 | — |
| SECONDARY Pegboard Task - 30 Minuites (Non-Dominant Hand) |
75.27; 70.17; 75.19; 72.76; 85.86; 83.85 | — |
Summary
The proposed study is the first to explore the contribution of brain glutamate systems, a major target of ethanol in the brain, to the vulnerability to develop alcoholism. This study may lead to an enhanced understanding of the underlying neurobiological mechanism in high risk individuals that may lead to the transition from moderate to excessive use of alcohol.
Eligibility Criteria
Inclusion Criteria
- Male and female between the ages of 21 and 30 years;
- medically and neurologically healthy on the basis of history, physical examination, EKG, Screening laboratories absence of current and/or past substance abuse on the basis of history and urine toxicology and breath alcohol levels at screening and on each test day.
For Family History Positive (FHP) Subjects: 1) Biological father and another first or second-degree biological relative with history of alcoholism by Family History Assessment Module (FHAM) developed by COGA.
Exclusion Criteria
- DSM-IV psychiatric and substance abuse (excluding alcohol abuse) diagnosis by history on psychiatric evaluation that includes a structured diagnostic interview (Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV Axis I Disorders (SCID))
- Subjects who meet criteria for alcohol abuse and express an interest in stopping alcohol use and/or express an interest in treatment or are currently enrolled in treatment for alcoholism, or have sought treatment in the last 6 months.
- history of counseling or psychotherapy; except family therapy centered around another family member
- extended unwillingness to remain alcohol-free for 48 hours prior to test days;
- for women: positive pregnancy test at screening or intention to engage in unprotected sex during the study
- alcohol naïve
- Adoptee and no contact with family members.
Data sourced from ClinicalTrials.gov (NCT00612352). 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.