Viewing Study NCT02461693


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Study NCT ID: NCT02461693
Status: COMPLETED
Last Update Posted: 2017-07-12
First Post: 2015-06-01
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Evaluating the Role of Expectations in Response to Caffeine Consumption: An RCT
Sponsor: University of Alabama at Birmingham
Organization:

Study Overview

Official Title: Evaluating the Role of Expectations in Response to Caffeine Consumption: A Randomized Control Trial
Status: COMPLETED
Status Verified Date: 2017-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: