Combined Effects of Alcohol and Caffeine
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|ClinicalTrials.gov Identifier: NCT01289561|
Recruitment Status : Completed
First Posted : February 3, 2011
Last Update Posted : February 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Alcohol or Other Drugs Effects||Drug: Alcohol + Caffeine Beverage Drug: Alcohol + Caffeine-placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Combined Effects of Alcohol and Caffeine|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
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).
Drug: 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).
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).
- 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.
- 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
- 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
- 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.
- 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:
- 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?
- 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:
- How much do you want another drinking right now?
- How intoxicated do you feel?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01289561
|United States, Maryland|
|Behavioral Pharmacology Research Unit|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Roland R Griffiths, Ph.D.||Johns Hopkins University|