Combined Effects of Alcohol and Caffeine

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roland Griffiths, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01289561
First received: February 1, 2011
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to investigate the effects of caffeine on the self-administration of alcohol. The study will also examine the combined effects of alcohol and caffeine on behavioral performance, participant ratings of behavioral performance, and self-reported subjective effects.


Condition Intervention Phase
Alcohol or Other Drugs Effects
Drug: Alcohol + Caffeine Beverage
Drug: Alcohol + Caffeine-placebo
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Combined Effects of Alcohol and Caffeine

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Total beverage consumed [ Time Frame: Measured during 2.5 hour drinking period ] [ Designated as safety issue: No ]
    The primary outcome measure is the total volume of beverage consumed during alcohol + caffeine sessions and alcohol + caffeine-placebo sessions.


Secondary Outcome Measures:
  • Circular Lights Task [ Time Frame: Approximately every 30 minutes of the 5.5 hour study period ] [ Designated as safety issue: No ]
    The Circular Lights Task is a measure of behavioral performance

  • The Biphasic Alcohol Effects Scale [ Time Frame: Approximately every 30 minutes of the 5.5 hour study period ] [ Designated as safety issue: No ]
    The Biphasic Alcohol Effects Scale (BAES: Martin et al., 1993) will be repeatedly administered to assess changes in subjective alcohol effects over time. This measure is a commonly used 14-item scale that assesses stimulant (7 items) and sedative (7 items) subjective effects of drugs on a 10-point likert scale

  • Expired air breath alcohol measures [ Time Frame: Approximately every 30 minutes during the 5.5 hour study period ] [ Designated as safety issue: No ]
    Breath alcohol measures will be taken repeatedly in order to assess blood alcohol levels, as well as assure safe discharge. In order to prevent mouth alcohol contamination of breath alcohol measurements, participants will be required to abstain from drinking for 5 minutes before each measurement and to rinse their mouth out thoroughly with water immediately before breath alcohol measures.

  • Subjective ratings 9-point likert scale [ Time Frame: Approximately every 30 minutes during the 5.5 hour study period ] [ Designated as safety issue: No ]

    The following three questions will be asked on a 9-point likert scale:

    1. How much do you like the beverage you have been drinking today?
    2. Rate your sense of "well-being" right now.
    3. How much money would you be willing to pay for a standard mixed drink serving (e.g., 8 oz.) of this beverage at a bar?

  • Subjective ratings visual analogue scale [ Time Frame: Approximately every 30 minutes during the 5.5 hour study period ] [ Designated as safety issue: No ]

    The following two questions will be answered on a visual analogue scale:

    1. How much do you want another drinking right now?
    2. How intoxicated do you feel?


Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alcohol self-administration
All participants will participate in seven sessions. In three sessions, each participant will consume a beverage containing alcohol and caffeine. In three separate sessions, participants will consume a beverage containing alcohol and caffeine-placebo. In the final session, all participants may choose which beverage they consume. Participants and research assistants will be blinded to inclusion of caffeine/caffeine-placebo in beverage, but each beverage will be labeled for identification (e.g., A or B).
Drug: Alcohol + Caffeine Beverage
14 g alcohol per 180 ml total beverage combined with 60 mg caffeine per 180 ml total beverage. The alcohol and caffeine will be mixed in a fruit punch beverage. Participants may self-administer as much beverage as they like with several constraints to assure safety (e.g., participants must stop drinking if their blood alcohol content is above .12 g/dl).
Other Names:
  • Alcohol 190 proof USP
  • Caffeine anhydrous USP
Drug: Alcohol + Caffeine-placebo
14 g alcohol per 180 ml total beverage combined with 2.2 mg quinine per 180 ml total beverage. The alcohol and quinine will be mixed in a fruit punch beverage. Participants may self-administer as much beverage as they like with several constraints to assure safety (e.g., participants must stop drinking if their blood alcohol content is above .12 g/dl).
Other Names:
  • Alcohol 190 proof USP
  • Quinine hydrochloride dihydrate

Detailed Description:

The purpose of this study is to examine the effects of caffeine on alcohol self-administration. Volunteers will participate in 7 experimental sessions in which they will be given the opportunity to self-administer an alcohol + caffeine or alcohol + caffeine-placebo beverage. The first 6 sessions will involve exposure to the two beverage conditions in mixed order three times each (e.g., A, B, B, A, A, B). The seventh session will be a choice session in which the participant will make a single choice at the beginning of the session about which beverage they will consume that day. In addition to the primary outcomes of quantity of alcohol self-administered and beverage choice, three additional outcomes will be measured including: 1). indirect measures of reinforcing effects (e.g. subjective ratings of liking, well-being, take again); 2). an alcohol-sensitive behavioral measure; and 3). participant ratings of degree of behavioral impairment.

  Eligibility

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

Inclusion Criteria:

  • Very light or moderate consumer of caffeine (either daily or non-daily).
  • Social drinker of alcohol.
  • Has experience in lifetime of heavy alcohol consumption.
  • Read, write, and speak English fluently.

Exclusion Criteria:

  • Serious and unstable illnesses including current hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, uncontrolled hypertension, and congestive heart failure), endocrinologic, neurologic (including stroke, transient ischemic attack, subarachnoidal bleeding, brain tumor, encephalopathy, and meningitis), or hematologic disease.
  • Parkinson's disease, seizure disorder, or history of significant head trauma.
  • Current psychiatric illness
  • Pregnant or nursing women or women who are not using an effective means of birth control.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289561

Locations
United States, Maryland
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Roland R Griffiths, Ph.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Roland Griffiths, Professor, Department of Psychiatry,, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01289561     History of Changes
Other Study ID Numbers: NA_00036826, 5R01DA003890-25
Study First Received: February 1, 2011
Last Updated: September 18, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Caffeine
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Central Nervous System Stimulants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P1 Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014