Combined Effects of Alcohol and Caffeine

Johns Hopkins University

Status and phase: Completed; Phase 1

Conditions: Alcohol or Other Drugs Effects

Treatments: Drug: Alcohol + Caffeine-placebo; Drug: Alcohol + Caffeine Beverage

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01289561

5R01DA003890-25 (U.S. NIH Grant/Contract)

NA_00036826

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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20 participants in 1 patient group

Alcohol self-administration

Experimental group

Description:

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).

Treatment:

Drug: Alcohol + Caffeine Beverage

Drug: Alcohol + Caffeine-placebo