Interactive Effects of IV Ethanol and IV Nicotine

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Collaborator: South Central VA Mental Illness Research, Education & Clinical Center
• Treatments: Ethanol; Nicotine

Criteria

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.