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| Name | Class |
|---|---|
| South Central VA Mental Illness Research, Education & Clinical Center | FED |
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There are mixed reports on nicotine's effects on ethanol-induced impairment in cognitive performance and behavior in humans. The main objective of this study is to characterize the interactive effects of acute intravenous (IV) ethanol and nicotine administration on cognition and behavior in healthy smokers. The general hypothesis is that nicotine will attenuate the negative effects of ethanol on cognition and subjective stimulant/sedative effects of ethanol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravenous ethanol placebo and nicotine infusions | Placebo Comparator | Each subject will participate in three separate interventions. Each intervention will include three nicotine infusions (placebo and 2 active conditions). The interventions will differ on the ethanol infusion: placebo or one of two ethanol concentrations. |
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| intravenous ethanol 40% and nicotine infusions | Active Comparator | Each subject will participate in three separate interventions. Each intervention will include three nicotine infusions (placebo and 2 active conditions). The interventions will differ on the ethanol infusion: placebo or one of two ethanol concentrations. |
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| intravenous ethanol 100% and nicotine infusions | Active Comparator | Each subject will participate in three separate interventions. Each intervention will include three nicotine infusions (placebo and 2 active conditions). The interventions will differ on the ethanol infusion: placebo or one of two ethanol concentrations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous ethanol placebo plus nicotine infusions | Drug | nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg |
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| Measure | Description | Time Frame |
|---|---|---|
| Biphasic Alcohol Effects Scale (BAES) | A 14-item scale with 7 items designed to assess stimulant effects associated with the ascending limb of ethanol intoxication and 7 items developed to measure sedative effects associated with the descending limb of ethanol intoxication. | 2 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scales of Mood States | The following items will be assessed: high, depressed, anxious, drowsy, irritable, tired, sad, angry, nervous, nauseous, blurred vision, flushed, headache, lightheaded, dizzy, sweating, abdominal discomfort and tingling . | 1 minute |
| QSU-Brief |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Ralevski, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Haven VA Hospital | West Haven | Connecticut | 06516 | United States |
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| intravenous ethanol 40mg% plus nicotine infusions | Drug | nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg |
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| intravenous ethanol 100mg% plus nicotine infusions | Drug | nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg |
|
A measure of smoking urges reflecting not only intent and desire to smoke, and anticipation of pleasure from smoking, but also anticipation of relief from negative affect and nicotine withdrawal, and urgent and overwhelming desire to smoke. |
| 2 minutes |
| Digit Symbol Substitution Task | A test of psychomotor performance, which measures motor persistence, sustained attention, response speed and visuomotor coordination. | 2 minutes |