Interactive Effects of IV Ethanol and IV Nicotine

NCT01814410 | Completed Early Phase 1

• 1 other identifier: 1209010841
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Intravenous Ethanol; Intravenous Nicotine; Interactive effects; cognition; subjective effects; healthy subjects

Outcome Measures

Primary Outcomes (1)

• Biphasic Alcohol Effects Scale (BAES)

  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.

  2 minutes

Secondary Outcomes (3)

• Visual Analog Scales of Mood States

  1 minute

• QSU-Brief

  2 minutes

• Digit Symbol Substitution Task

  2 minutes

Study Arms (3)

intravenous ethanol placebo and nicotine infusions

PLACEBO COMPARATOR

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.

Drug: Intravenous ethanol placebo plus nicotine infusions

intravenous ethanol 40% and nicotine infusions

ACTIVE COMPARATOR

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.

Drug: intravenous ethanol 40mg% plus nicotine infusions

intravenous ethanol 100% and nicotine infusions

ACTIVE COMPARATOR

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.

Drug: intravenous ethanol 100mg% plus nicotine infusions

Interventions

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 placebo and nicotine infusions

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 40% and nicotine infusions

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

intravenous ethanol 100% and nicotine infusions

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• South Central VA Mental Illness Research, Education & Clinical Center: collaborator

Study Sites (1)

West Haven VA Hospital

West Haven, Connecticut, 06516, United States

Location

Study Officials

• Elizabeth Ralevski, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2013
• First Posted: March 20, 2013
• Study Start: February 22, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

US (1)