Official Title: “Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans”

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.

Study Type: Interventional

Study Design: Other, Double Blind (Subject, Investigator, Outcomes Assessor), Single Group Assignment

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: Nicotine
  • 1.0 microg/kg/min IV x 10 minutes
• Drug: Ethanol
  • IV

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Three test days, within-subject design.

Primary Measures

• Continuous Performance Task-Identical Pairs
  • Time Frame: Baseline and each test day
    Safety Issue?: No
• Rey Auditory Verbal Learning Task
  • Time Frame: Each test day
    Safety Issue?: No

Secondary Measures

• Balloon Analog Risk Task
  • Time Frame: Baseline and each test day
    Safety Issue?: No
• Visual Analog Scales of Mood States
  • Time Frame: Each test day
    Safety Issue?: No
• Biphasic Alcohol Effects Scale
  • Time Frame: Each test day
    Safety Issue?: No
• Questionnaire of Smoking Urges
  • Time Frame: Each test day
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

Edward B Perry, M.D. Principal Investigator Yale University  

Overall Contact: Vanessa Bufis 203-932-5711 vanessa.bufis@yale.edu

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00616746

Study ID Number: 0607001614

ClinicalTrials.gov Identifier: NCT00616746

Health Authority: United States: Food and Drug Administration