Combined Effects of Alcohol and Caffeine

NCT ID: NCT01289561

Last Updated: 2016-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-01-31

Brief Summary

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.

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.

Conditions

Alcohol or Other Drugs Effects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Alcohol + Caffeine Beverage

Intervention Type: 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).

Alcohol + Caffeine-placebo

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

Alcohol 190 proof USP; Caffeine anhydrous USP; Alcohol 190 proof USP; Quinine hydrochloride dihydrate

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Roland Griffiths

Professor, Department of Psychiatry,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roland R Griffiths, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

5R01DA003890-25

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00036826

Identifier Type: -

Identifier Source: org_study_id