- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01289561
Combined Effects of Alcohol and Caffeine
February 23, 2016 updated by: Roland Griffiths, Johns Hopkins University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Behavioral Pharmacology Research Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
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:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Measured during 2.5 hour drinking period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Approximately every 30 minutes of the 5.5 hour study period
|
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
|
Approximately every 30 minutes of the 5.5 hour study period
|
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.
|
Approximately every 30 minutes during the 5.5 hour study period
|
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:
|
Approximately every 30 minutes during the 5.5 hour study period
|
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:
|
Approximately every 30 minutes during the 5.5 hour study period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Roland R Griffiths, Ph.D., Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
February 1, 2011
First Submitted That Met QC Criteria
February 2, 2011
First Posted (Estimate)
February 3, 2011
Study Record Updates
Last Update Posted (Estimate)
February 24, 2016
Last Update Submitted That Met QC Criteria
February 23, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Purinergic Antagonists
- Purinergic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Neuromuscular Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Central Nervous System Stimulants
- Antimalarials
- Muscle Relaxants, Central
- Ethanol
- Caffeine
- Quinine
Other Study ID Numbers
- NA_00036826
- 5R01DA003890-25 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol or Other Drugs Effects
-
Research Foundation for Mental Hygiene, Inc.CompletedAlcohol or Other Drugs UseUnited States
-
National Development and Research Institutes, Inc.Syracuse VA Medical Center; The VA Western New York Healthcare SystemUnknownPost-Traumatic Stress Symptoms | Problematic Use of Alcohol or Other DrugsUnited States
-
University of ChicagoCompletedAlcohol Drinking | Drinking Behavior | Physiological Effects of Drugs | Central Nervous System DepressionUnited States
-
RANDCompleted
-
Janssen Korea, Ltd., KoreaCompletedMental Disorders | Schizophrenia | Tranquilizing Agents | Therapeutic Uses | Physiological Effects of Drugs | Psychotropic Drugs | Antipsychotic Agents
-
Mclean HospitalNational Institute on Drug Abuse (NIDA)UnknownPsychotropic Drugs EffectsUnited States
-
Universidade Federal do Rio de JaneiroRecruitingPhysiological Effects of DrugsBrazil
-
Yale UniversityActive, not recruitingEthanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study I (THC-ETOH-I)Cannabis | Alcohol Effect | Driving Under the Influence of Alcohol and Other DrugsUnited States
-
Albert Einstein College of MedicineCompleted
-
University of ChicagoCompletedSubstance-Related Disorders | Alcohol Drinking | Drinking Behavior | Binge Drinking | Ethanol | Physiological Effects of Drugs | Central Nervous System Depressants
Clinical Trials on Alcohol + Caffeine Beverage
-
University of New MexicoThe Mind Research NetworkCompletedAlcohol Consumption | Domestic ViolenceUnited States
-
University of Texas at AustinRecruitingAlcohol Drinking | Bipolar Disorder | Alcohol Use DisorderUnited States
-
University of Texas at AustinRecruitingAlcohol Drinking | Bipolar Disorder | Alcohol Use DisorderUnited States
-
National Institute on Alcohol Abuse and Alcoholism...RecruitingAlcohol Use DisorderUnited States
-
Medical University of ViennaUnknownPerceived Alcohol IntoxicationAustria
-
Syracuse UniversityBoston University; National Institute on Alcohol Abuse and Alcoholism (NIAAA); University of South DakotaCompletedAlcohol Drinking | Men | Sex BehaviorUnited States
-
University of Texas at AustinRecruitingAlcohol Drinking | Bipolar Disorder | Alcohol Use DisorderUnited States
-
Unilever R&DCompletedSatiety | AppetiteUnited Kingdom
-
Eli Lilly and CompanyCompleted
-
University of CopenhagenCarlsberg Breweries A/SCompletedInsulin Resistance | Alcohol ConsumptionDenmark