Alcohol or Other Drugs EffectsPhase 1NCT01289561
Combined Effects of Alcohol and Caffeine
A Phase 1 study testing Alcohol + Caffeine Beverage in people with Alcohol or Other Drugs Effects, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol or Other Drugs Effects
- What is being tested?
- Alcohol + Caffeine Beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
About this study
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.
Read the 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
- Being tested
- Alcohol + Caffeine Beverage, Alcohol + Caffeine-placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol + Caffeine BeverageDrug
Also called Alcohol 190 proof USP, Caffeine anhydrous USP
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-placeboDrug
Also called Alcohol 190 proof USP, Quinine hydrochloride dihydrate
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).
| Study group | Role | What they receive |
|---|---|---|
| Alcohol self-administration | Experimental | 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). Receives: Drug: Alcohol + Caffeine Beverage; Drug: Alcohol + Caffeine-placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total beverage consumed
The primary outcome measure is the total volume of beverage consumed during alcohol + caffeine sessions and alcohol + caffeine-placebo sessions.
Measured: Measured during 2.5 hour drinking period
Secondary outcomes (5)
Circular Lights Task
The Circular Lights Task is a measure of behavioral performance
Measured: Approximately every 30 minutes of the 5.5 hour study period
The Biphasic Alcohol Effects Scale
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
Measured: Approximately every 30 minutes of the 5.5 hour study period
Expired air breath alcohol measures
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.
Measured: Approximately every 30 minutes during the 5.5 hour study period
Subjective ratings 9-point likert scale
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?
Measured: Approximately every 30 minutes during the 5.5 hour study period
Subjective ratings visual analogue scale
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?
Measured: Approximately every 30 minutes during the 5.5 hour study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol or Other Drugs EffectsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Roland Griffiths, Johns Hopkins University
- Investigators
- Roland R Griffiths, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289561
- Sponsor's protocol ID
- NA_00036826
- Other IDs
- 5R01DA003890-25
- Status last verified
- Feb 2016
- First submitted
- 1 Feb 2011
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Alcohol and Caffeine
- ClinicalTrials.gov ID
- NCT01289561
- Acronym / sponsor ID
- NA_00036826
- Conditions
- Alcohol or Other Drugs Effects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alcohol self-administration | Experimental | Drug: Alcohol + Caffeine Beverage, Drug: Alcohol + Caffeine-placeboAll 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). |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol + Caffeine BeverageAlso: Alcohol 190 proof USP, Caffeine anhydrous USP14 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). | Drug | Alcohol self-administration |
| Alcohol + Caffeine-placeboAlso: Alcohol 190 proof USP, Quinine hydrochloride dihydrate14 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). | Drug | Alcohol self-administration |
Primary outcome
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.
5 secondary outcomes
Circular Lights Task
Time frame: 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
Expired air breath alcohol measures
Time frame: 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
Subjective ratings visual analogue scale
Time frame: Approximately every 30 minutes during the 5.5 hour study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland R Griffiths, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alcohol + Caffeine Beverage in people with Alcohol or Other Drugs Effects, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total beverage consumed (time frame: Measured during 2.5 hour drinking period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.