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Completed

NCT Number: NCT01289561

Combined Effects of Alcohol and Caffeine

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.

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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alcohol + Caffeine Beverage

Drug

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

Alcohol + Caffeine-placebo

Drug

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

Primary outcomes

  1. Total beverage consumed

    Time frame: Measured during 2.5 hour drinking period

    The primary outcome measure is the total volume of beverage consumed during alcohol + caffeine sessions and alcohol + caffeine-placebo sessions.

Secondary outcomes

  1. Circular Lights Task

    Time frame: Approximately every 30 minutes of the 5.5 hour study period

    The Circular Lights Task is a measure of behavioral performance

  2. The Biphasic Alcohol Effects Scale

    Time frame: Approximately every 30 minutes of the 5.5 hour study period

    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

  3. Expired air breath alcohol measures

    Time frame: Approximately every 30 minutes during the 5.5 hour study period

    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.

  4. Subjective ratings 9-point likert scale

    Time frame: Approximately every 30 minutes during the 5.5 hour study period

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

    • How much do you like the beverage you have been drinking today?
    • Rate your sense of "well-being" right now.
    • 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?
  5. Subjective ratings visual analogue scale

    Time frame: Approximately every 30 minutes during the 5.5 hour study period

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

    • How much do you want another drinking right now?
    • How intoxicated do you feel?

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 3, 2011
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.