Clinical trial NCT01289561: Combined Effects of Alcohol and Caffeine
Official title: Combined Effects of Alcohol and Caffeine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol or Other Drugs Effects
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-02-03
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Total beverage consumed
timeFrame: Measured during 2.5 hour drinking period
Secondary outcomes:
measure: Circular Lights Task
timeFrame: Approximately every 30 minutes of the 5.5 hour study period
measure: The Biphasic Alcohol Effects Scale
timeFrame: Approximately every 30 minutes of the 5.5 hour study period
measure: Expired air breath alcohol measures
timeFrame: Approximately every 30 minutes during the 5.5 hour study period
measure: Subjective ratings 9-point likert scale
timeFrame: Approximately every 30 minutes during the 5.5 hour study period
measure: Subjective ratings visual analogue scale
timeFrame: Approximately every 30 minutes during the 5.5 hour study period
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Behavioral Pharmacology Research Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Roland R Griffiths, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: