Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans

Condition(s) targeted: Alcohol Consumption; Tobbaco Use

Intervention: Nicotine (Drug); Ethanol (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Edward B Perry, M.D., Principal Investigator, Affiliation: Yale University

Overall contact:
Vanessa Bufis, Phone: 203-932-5711, Ext: 2526, Email: vanessa.bufis@yale.edu

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.

Official title: Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans

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

Primary outcome:

Continuous Performance Task-Identical Pairs

Rey Auditory Verbal Learning Task

Secondary outcome:

Balloon Analog Risk Task

Visual Analog Scales of Mood States

Biphasic Alcohol Effects Scale

Questionnaire of Smoking Urges

Minimum age: 21 Years. Maximum age: 50 Years. Gender(s): Both.

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.

Vanessa Bufis, Phone: 203-932-5711, Ext: 2526, Email: vanessa.bufis@yale.edu

VA Connecticut Healthcare System, West Haven Campus, West Haven, Connecticut 06516, United States; Recruiting
Edward B Perry, M.D., Principal Investigator

Starting date: January 2007
Ending date: July 2009
Last updated: February 4, 2008