Interactive Effects of IV Ethanol and IV Nicotine

Yale University

Status and phase: Completed; Early Phase 1

Conditions: Healthy

Treatments: Drug: intravenous ethanol 100mg% plus nicotine infusions; Drug: intravenous ethanol 40mg% plus nicotine infusions; Drug: Intravenous ethanol placebo plus nicotine infusions

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01814410

1209010841

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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5 participants in 3 patient groups, including a placebo group

intravenous ethanol placebo and nicotine infusions

Placebo Comparator group

Description:

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.

Treatment:

Drug: Intravenous ethanol placebo plus nicotine infusions

intravenous ethanol 40% and nicotine infusions

Active Comparator group

Description:

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.

Treatment:

Drug: intravenous ethanol 40mg% plus nicotine infusions

intravenous ethanol 100% and nicotine infusions

Active Comparator group

Description:

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.

Treatment:

Drug: intravenous ethanol 100mg% plus nicotine infusions