Evaluating the Role of Expectations in Response to Caffeine Consumption: An RCT

Caffeine Clinical Trial

Official title:

Evaluating the Role of Expectations in Response to Caffeine Consumption: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461693
• Other study ID #: F150410009
• Status: Completed
• Phase: N/A
• First received: June 1, 2015
• Last updated: November 23, 2015
• Start date: June 2015
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to examine the effect of expectancy on mood and alertness after consumption of caffeine "treatment" or placebo "control" pill, given that participants know their probability for receiving the caffeine versus placebo pill. Participants will be randomly assigned a probability (ranging from 0-100%) of receiving caffeine vs. placebo, and this probability will be revealed to them before consumption of the assigned pill and subsequent cognitive testing. At the time of consumption, neither study staff administering the intervention nor participants will know for certain which pill is given to each participant. Pill assignment will depend on pre-determined randomization probabilities, which will be provided and assigned by the study statistician. By revealing participants' individual probability of receiving the caffeine pill, we will induce positive or negative expectancies regarding likelihood for receipt of the caffeine pill. These experimental manipulations will: 1) estimate the effect of expectancy on cognitive and affective outcomes, and 2) allow for a more direct estimate of the effect of the caffeine pill under real-world conditions than would a conventional randomized trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 19 years-old or older

• available to participate on the dates specified

• willing to take a caffeine or placebo pill at study session

• currently enrolled at UAB

Exclusion Criteria:

• self-reported use of ADHD medication

• self-reported use of anxiety medication

• self-reported use of sleep medication

• self-reported use of nicotine products

• self-reported lactose intolerance

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Affect
• Caffeine
• Cognitive Ability, General
• Other Stimulant Use, Unspecified

Intervention

Drug:
• Caffeine
200mg delivered as pill; one-time dose
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mood state Score on POMS-2 test		30 minutes post pill consumption	No
Primary	Vigilance Score on computer-based test using random, visual stimulus		45 to 105 minutes post pill consumption	No