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Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans
This study is currently recruiting participants.
Verified by Yale University, February 2008
First Received: February 4, 2008   No Changes Posted
Sponsors and Collaborators: Yale University
VA Connecticut Healthcare System
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00616746
  Purpose

The purpose of this study is to characterize the interactive psychopharmacologic effects of acute intravenous (IV) alcohol and nicotine administration in male and female smokers and nonsmokers who use alcohol. The IV alcohol administration will be accomplished using the breath alcohol (BrAc) clamp method.

The primary hypothesis is that nicotine will attenuate the disruptive effects of alcohol on cognitive inhibition as measured by the Continuous Performance Task-Identical Pairs (CPT-IP) task, processing speed and attention as measured by the CPT-IP, and working memory as measured by the Rey Auditory Verbal Learning Task.

The secondary, exploratory hypothesis is that nicotine will attenuate the disruptive effects of alcohol on impulse control (risky decision-making) as measured by the Balloon Analog Risk Task. We also hypothesize that administration of nicotine will decrease alcohol-induced inhibitory effects as measured by the Visual Analog Scales of Mood States and the Biphasic Alcohol Effects Scale, and that alcohol will increase nicotine craving and withdrawal as measured by the QSU-Brief.


Condition Intervention
Alcohol Consumption
Tobbaco Use
Drug: Nicotine
Drug: Ethanol

MedlinePlus related topics: Alcohol
Drug Information available for: Ethanol Nicotine tartrate Nicotine polacrilex
U.S. FDA Resources
Study Type: Interventional
Study Design: Double Blind (Subject, Investigator, Outcomes Assessor), Single Group Assignment
Official Title: Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Continuous Performance Task-Identical Pairs [ Time Frame: Baseline and each test day ] [ Designated as safety issue: No ]
  • Rey Auditory Verbal Learning Task [ Time Frame: Each test day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Balloon Analog Risk Task [ Time Frame: Baseline and each test day ] [ Designated as safety issue: No ]
  • Visual Analog Scales of Mood States [ Time Frame: Each test day ] [ Designated as safety issue: No ]
  • Biphasic Alcohol Effects Scale [ Time Frame: Each test day ] [ Designated as safety issue: No ]
  • Questionnaire of Smoking Urges [ Time Frame: Each test day ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: January 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Three test days, within-subject design.
Drug: Nicotine
1.0 microg/kg/min IV x 10 minutes
Drug: Ethanol
IV

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 (CBC w/ differential, TSH, free-T4, AST, ALT, GGT, BUN, creatinine, calcium, phosphorous, magnesium, total protein, albumin, electrolytes, VDRL, urinalysis, serum beta-HCG for women of childbearing potential);
  4. currently smoking cigarettes (no more than 1 pack per day; subjects who smoke pipes and/or cigars only will be excluded) and not interested in stopping smoking or not currently smoking but have tried cigarettes in the past;
  5. have had at least 4 drinks on at least 2 occasions in the past year and are not interested in stopping drinking;
  6. absence of current and past substance abuse, with the exception of alcohol abuse on the basis of history and urine toxicology and breath alcohol levels at screening and on each test day.

Exclusion Criteria:

  1. Present or past DSM-IV psychiatric and substance abuse/dependence, with the exception of alcohol, diagnosis by history and psychiatric evaluation including a Structured Clinical Interview for DSM-IV Non-Patient (SCID-NP)(45);
  2. Subjects who meet criteria for alcohol abuse and express an interest in stopping alcohol use and/or express an interest in treatment or are currently enrolled in treatment for alcoholism, or have sought treatment in the last 6 months;
  3. history of counseling or psychotherapy, except family therapy centered around another family member or marital therapy;
  4. for women of childbearing potential: positive pregnancy test or refusal to use contraception during the study;
  5. alcohol and/or nicotine naïve;
  6. history of psychosis in first degree relative.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616746

Contacts
Contact: Vanessa Bufis 203-932-5711 ext 2526 vanessa.bufis@yale.edu

Locations
United States, Connecticut
VA Connecticut Healthcare System, West Haven Campus Recruiting
West Haven, Connecticut, United States, 06516
Principal Investigator: Edward B Perry, M.D.            
Sponsors and Collaborators
Yale University
VA Connecticut Healthcare System
Investigators
Principal Investigator: Edward B Perry, M.D. Yale University
  More Information

No publications provided

Responsible Party: Yale University School of Medicine ( Edward Perry, M.D. )
Study ID Numbers: 0607001614
Study First Received: February 4, 2008
Last Updated: February 4, 2008
ClinicalTrials.gov Identifier: NCT00616746     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Alcohol, nicotine

Study placed in the following topic categories:
Nicotine polacrilex
Neurotransmitter Agents
Nicotine
Nicotinic Agonists
Drinking Behavior
Central Nervous System Stimulants
Peripheral Nervous System Agents
Cholinergic Agents
Alcohol Drinking
Ethanol

Additional relevant MeSH terms:
Nicotine polacrilex
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Nicotinic Agonists
Physiological Effects of Drugs
Drinking Behavior
Central Nervous System Stimulants
Alcohol Drinking
Cholinergic Agents
Pharmacologic Actions
Nicotine
Autonomic Agents
Therapeutic Uses
Ganglionic Stimulants
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009