Interactive Effects of IV Ethanol and IV Nicotine

Study Overview
=================
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.

Official Title
-----------------
A Laboratory Study on the Interactive Effects of IV Ethanol and IV Nicotine on Subjective Effects and Cognition

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Intravenous ethanol placebo plus nicotine infusions
* Drug: intravenous ethanol 40mg% plus nicotine infusions
* Drug: intravenous ethanol 100mg% plus nicotine infusions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female; between the ages of 21 and 50 years; medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratories history of smoking daily for the past 12 months, at least 5 cigarettes daily; not seeking treatment for nicotine dependence 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: history of major medical illnesses that the physician investigator deems as contraindicated for the patient to be in the study; 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; current abuse of any recreational or prescription drugs (except alcohol); alcohol naïve.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: intravenous ethanol placebo and nicotine infusions<br>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. | Drug: Intravenous ethanol placebo plus nicotine infusions<br>* nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg<br>|
| Active Comparator: intravenous ethanol 40% and nicotine infusions<br>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. | Drug: intravenous ethanol 40mg% plus nicotine infusions<br>* nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg<br>|
| Active Comparator: intravenous ethanol 100% and nicotine infusions<br>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. | Drug: intravenous ethanol 100mg% plus nicotine infusions<br>* nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intravenous Ethanol, Intravenous Nicotine, Interactive effects, cognition, subjective effects, healthy subjects