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Interactive Effects of IV Ethanol and IV Nicotine

NCT01814410 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-01-17

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Intravenous ethanol placebo plus nicotine infusions

nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg

DRUG

intravenous ethanol 40mg% plus nicotine infusions

nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg

DRUG

intravenous ethanol 100mg% plus nicotine infusions

nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg

Sponsors & Collaborators

  • South Central VA Mental Illness Research, Education & Clinical Center

    collaborator FED

  • Yale University

    lead OTHER

Principal Investigators

  • Elizabeth Ralevski, Ph.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-22
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01814410 on ClinicalTrials.gov