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Completed

NCT Number: NCT01814410

Interactive Effects of IV Ethanol and IV Nicotine

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.

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Key information

Conditions

Healthy

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

West Haven VA Hospital

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravenous ethanol placebo plus nicotine infusions

Drug

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

intravenous ethanol 40mg% plus nicotine infusions

Drug

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

intravenous ethanol 100mg% plus nicotine infusions

Drug

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

Primary outcomes

  1. Biphasic Alcohol Effects Scale (BAES)

    Time frame: 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 outcomes

  1. Visual Analog Scales of Mood States

    Time frame: 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 .

  2. QSU-Brief

    Time frame: 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.

  3. Digit Symbol Substitution Task

    Time frame: 2 minutes

    A test of psychomotor performance, which measures motor persistence, sustained attention, response speed and visuomotor coordination.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 20, 2013
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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