Healthy
Conditions
Keywords
Intravenous Ethanol, Intravenous Nicotine, Interactive effects, cognition, subjective effects, healthy subjects
Brief summary
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.
Interventions
DRUGIntravenous ethanol placebo plus nicotine infusions
nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg
DRUGintravenous ethanol 40mg% plus nicotine infusions
nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg
DRUGintravenous ethanol 100mg% plus nicotine infusions
nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg
Sponsors
South Central VA Mental Illness Research, Education & Clinical Center
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female; 2. between the ages of 21 and 50 years; 3. medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratories 4. history of smoking daily for the past 12 months, at least 5 cigarettes daily; not seeking treatment for nicotine dependence 5. social drinkers no maximum level of alcohol consumption will be defined a priori but individuals who met current DSM -IV criteria for alcohol dependence (abuse will be allowed) will be excluded from the study.
Exclusion criteria
1. history of major medical illnesses that the physician investigator deems as contraindicated for the patient to be in the study; 2. regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia or panic disorder; 3. current abuse of any recreational or prescription drugs (except alcohol); 4. alcohol naïve.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biphasic Alcohol Effects Scale (BAES) | 2 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scales of Mood States | 1 minute | 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 . |
| QSU-Brief | 2 minutes | 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. |
| Digit Symbol Substitution Task | 2 minutes | A test of psychomotor performance, which measures motor persistence, sustained attention, response speed and visuomotor coordination. |
Countries
United States
Outcome results
None listed