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Completed

NCT Number: NCT02461693

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years-old or older
  • available to participate on the dates specified
  • willing to take a caffeine or placebo pills at study session
  • willingness to abstain from caffeine for 12 hours prior to study visit (8:30pm-8:30am)
  • UAB employees or students with some college education (including current enrollment)

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
  • self-reported uncorrected vision
  • self-reported pregnancy or trying to become pregnant

Treatment and study plan

Caffeine

Drug

200mg delivered as pill; one-time dose

Placebo

Drug

Lactose-based pill; one-time dose

Primary outcomes

  1. Mood State Score on POMS-2 Test

    Time frame: 30 minutes post pill consumption

    Profile of Mood States (POMS-2)- "Volunteers rated a series of 65 mood-related adjectives with regard to how they were feeling "right now" on a scale of 0 (not at all) to 4 (extremely). The adjectives factor into six mood sub-scales: Tension-Anxiety; Depression-Dejection; Anger-Hostility; Vigor-Activity; Fatigue-Inertia; Confusion-Bewilderment and a Total Mood Disturbance score which aggregates the six sub-scales into a single variable." - from our publication. The minimum and maximum possible raw scores were: 0 and 40 for Tension-Anxiety, 0 and 52 for Depression-Dejection, 0 and 44 for Anger-Hostility, 0 and 36 for Vigor-Aactivity, 0 and 24 for Fatigue-Inertia, 0 and 40 for Confusion-Bewilderment, -36 and 200 for Total Mood Disturbance, and 0 and 24 for Friendliness. For Friendliness and Vigor-Activity, the more positively a person feels, the higher the score. For all other sub-scales and Total Mood Disturbance, the more negatively a person feels, the higher the score.

  2. Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Proportion Correct (Out of 60)

    Time frame: 45 to 105 minutes post pill consumption

    Scanning Visual Vigilance Test. "This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes." - from our publication

  3. Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm Hits

    Time frame: 45 to 105 minutes post pill consumption

    Scanning Visual Vigilance Test. "This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes." - from our publication

  4. Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Mean Time to a Correct Hit

    Time frame: 45 to 105 minutes post pill consumption

    Scanning Visual Vigilance Test. "This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes." - from our publication

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 3, 2015
Registry last updated
Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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