Interactive Effects of IV Ethanol and IV Nicotine

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Intravenous ethanol placebo plus nicotine infusions; Drug: intravenous ethanol 100mg% plus nicotine infusions; Drug: intravenous ethanol 40mg% plus nicotine infusions

• Registration Number: NCT01814410
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-18
• Study Start: 2013-02-22
• Study First Submitted QC: 2013-03-19
• Study First Posted: 2013-03-20
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-12
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
intravenous ethanol placebo and nicotine infusions	Intravenous ethanol placebo plus nicotine infusions	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.
intravenous ethanol 100% and nicotine infusions	intravenous ethanol 100mg% plus nicotine infusions	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.
intravenous ethanol 40% and nicotine infusions	intravenous ethanol 40mg% plus nicotine infusions	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Digit Symbol Substitution Task	2 minutes	A test of psychomotor performance, which measures motor persistence, sustained attention, response speed and visuomotor coordination.
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.
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 .

Trial Locations

Locations (1)

West Haven VA Hospital; 🇺🇸 West Haven, Connecticut, United States