Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
5 participants
INTERVENTIONAL
2013-02-22
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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intravenous ethanol placebo and 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 placebo plus nicotine infusions
nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg
intravenous ethanol 40% and 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 40mg% plus nicotine infusions
nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg
intravenous ethanol 100% and 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 100mg% plus nicotine infusions
nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg
Interventions
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Intravenous ethanol placebo plus nicotine infusions
nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg
intravenous ethanol 40mg% plus nicotine infusions
nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg
intravenous ethanol 100mg% plus nicotine infusions
nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg
Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
50 Years
ALL
Yes
Sponsors
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South Central VA Mental Illness Research, Education & Clinical Center
FED
Yale University
OTHER
Responsible Party
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Principal Investigators
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Elizabeth Ralevski, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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West Haven VA Hospital
West Haven, Connecticut, United States
Countries
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Other Identifiers
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1209010841
Identifier Type: -
Identifier Source: org_study_id
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