Placebo EffectPhase 4CaCNCT03694886

The Effect of Tablet Size on Cognitive Performance Caffeine

A Phase 4 study testing Caffeine Anhydrous with small sucrose pill and Caffeine Anhydrous with large sucrose pill in people with Placebo Effect, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to assess if tablet size, due to placebo effect, alters participants' performance on cognitive tests after consuming caffeine. Participants will be randomly assigned to one of four groups: 1) 90 mg caffeine with a 1 mm diameter sucrose pillule; 2) no caffeine with the small sucrose pillule; 3) 90 mg… Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Placebo Effect
What is being tested?: Caffeine Anhydrous with small sucrose pill and Caffeine Anhydrous with large sucrose pill
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteUnited States
Study dates: 31 Oct 2018to 1 Mar 2019
Phase: Phase 4
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 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Fluent in written and spoken English
Ability to see color
No uncontrolled high blood pressure
No allergies to caffeine or sucrose
No history of heart disease
No untreated anxiety or depression
Non-pregnant
No caffeine consumed the day of participation

Who cannot join

Not fluent in written and/or spoken English
Uncontrolled high blood pressure
Color-blindness
Allergies to caffeine and/or sucrose
History of heart disease
Untreated anxiety or depression
Pregnant
Consumed caffeine on the day of participation

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Denver
Denver, Colorado, 80204

Other trials in United States

About this study

Official title: The Effect of Tablet Size on Cognitive Performance: A Randomized Control Trial Using Caffeine

Read the detailed description

Background: A capsule's physical design (e.g. shape, size, and color) affects individuals' perception of drug efficacy; that is, how well a drug is likely to work. The goal of this study is to assess the effects tablet size may have on participant's performance on cognitive testing since research has found differences between preparation methods. Method: 120 participants will be randomly assigned to one of four groups: 1) 90 mg caffeine with a 1 mm diameter sucrose pillule; 2) no caffeine with the small sucrose pillule; 3) 90 mg caffeine with a 5 mm sucrose pillule; 4) no caffeine with the large sucrose pillule. Participants will consume the designated placebo tablet with water (caffeinated or non-caffeinated); then, participants will provide weekly caffeine intake and complete the neutral portion of Velten's Mood Induction Procedure until 30 minutes have passed to allow for caffeine activation. Participants will complete the Stroop test, Trial Making Tests A and B, and the Rey Auditory Verbal Learning Test. Previous literature, as far as the author knows, relied on evaluating drug efficacy based on appearance alone. This study aims to assess if tablet size, due to placebo effect, alters participants' performance on cognitive tests after consuming caffeine.

Conditions: Placebo Effect
Being tested: Caffeine Anhydrous with small sucrose pill, Placebo - large sucrose pill, Caffeine Anhydrous with large sucrose pill, Placebo - small sucrose pill

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Caffeine Anhydrous with small sucrose pillDrug
Also called pure caffeine powder
caffeine anhydrous that has been weighed out to 90 mg per dose presented with a 1 mm sucrose pillule
Placebo - large sucrose pillOther
Also called sugar pill
sucrose pillules of 5 mm diameter will be given to all participants in the large pill groups
Caffeine Anhydrous with large sucrose pillDrug
Also called pure caffeine powder
caffeine anhydrous that has been weighed out to 90 mg per dose presented with a 5 mm sucrose pillule
Placebo - small sucrose pillOther
Also called sugar pill
sucrose pillules of 1 mm diameter will be given to all participants in the small pill groups

Study groups in NCT03694886
Study group	Role	What they receive
Caffeine with small sucrose pill	Active comparator	Participants will be given one dose of 90 milligrams caffeine anhydrous dissolved in 8 ounces of water and a 1 mm sucrose pill to consume in 10 minutes. After 30 minutes post-administration, the cognitive tests will be administered. Receives: Drug: Caffeine Anhydrous with small sucrose pill
Caffeine with large sucrose pill	Active comparator	Participants will be given one dose of 90 milligrams caffeine anhydrous dissolved in 8 ounces of water and a 5 mm sucrose pill to consume in 10 minutes. After 30 minutes post-administration, the cognitive tests will be administered. Receives: Drug: Caffeine Anhydrous with large sucrose pill
No caffeine with small sucrose pill	Placebo comparator	Participants will be given 8 ounces of water and a 1 mm sucrose pill to consume in 10 minutes. After 30 minutes post-administration, the cognitive tests will be administered. Receives: Other: Placebo - small sucrose pill
No caffeine with large sucrose pill	Placebo comparator	Participants will be given 8 ounces of water and a 1 mm sucrose pill to consume in 10 minutes. After 30 minutes post-administration, the cognitive tests will be administered. Receives: Other: Placebo - large sucrose pill

What is being measured

The primary outcome is the main question the study is designed to answer.

Stroop Color test
Measures processing speed. 100-item, time-trial task where participants read the color of printed items on the task paper as quickly as possible for 45 seconds. Scores are measured in the number of correct responses within the allotted time.
Measured: Within 90 minutes of receiving informed consent. Actual task time: approximately 1.5 minutes
Stroop Word test
Measures processing speed. 100-item, time-trial task where participants read color names printed on the task paper as quickly as possible for 45 seconds. Scores are measured in the number of correct responses within the allotted time.
Measured: Within 90 minutes of receiving informed consent. Actual task time: approximately 1.5 minutes
Trail Making task A
Measures processing speed. 25 item, time-trial task where participants must connect numbers in order as quickly as possible. Scores are measured by the amount of time (in seconds) for participants to complete the task.
Measured: Within 90 minutes of receiving informed consent. Actual task time: approximately 2 minutes

Secondary outcomes (3)

Stroop Color-and-Word test
Measures processing speed. 100-item, time-trial task where participants must read the color of the ink instead of color names printed on the task paper as quickly as possible for 45 seconds. Scores are measured in the number of correct responses within the allotted time.
Measured: Within 90 minutes of receiving informed consent. Actual task time: approximately 2 minutes
Trail Making task B
Measures processing speed. 25 item, time-trial task where participants must connect numbers and letters in order (e.g. 1-A-2-B, etc.) as quickly as possible. Scores are measured by the amount of time (in seconds) for participants to complete the task.
Measured: Within 90 minutes of receiving informed consent. Actual task time: approximately 3 minutes
Rey Auditory Verbal Learning test
Measures memory. 30-item, 2 section task where participants are read 15 words and asked to recall as many words as possible in the first section. A second set of 15 words is then introduced and participants recall those. The second section consists of revisiting the original set of words and recalling as many of those. Scores are measured by the total words remembered in section one, and another score for the total intrusions from the second list into the recall of section two.
Measured: Within 90 minutes of receiving informed consent. Actual task time: approximately 40 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 20181 Mar 2019

First posted3 Oct 2018
Study start31 Oct 2018
Primary completion1 Mar 2019
Study completion1 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Placebo EffectStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe 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 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomly assigned to one of four groups: 1\) 90 mg caffeine with a 1 mm diameter sucrose pillule; 2) no caffeine with the small sucrose pillule; 3) 90 mg caffeine with a 5 mm sucrose pillule; 4) no caffeine with the large sucrose pillule.
Masking: Single blind
Who is masked: Participant
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03694886
Sponsor's protocol ID: 18-1086
Acronym: CaC
Status last verified: Apr 2019
First submitted: 1 Oct 2018
Last updated: 17 Apr 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Beaumont R, Cordery P, Funnell M, Mears S, James L, Watson P. Chronic ingestion of a low dose of caffeine induces tolerance to the performance benefits of caffeine. J Sports Sci. 2017 Oct;35(19):1920-1927. doi: 10.1080/02640414.2016.1241421. Epub 2016 Oct 20.
PubMed 27762662
Buckalew LW, Coffield KE. An investigation of drug expectancy as a function of capsule color and size and preparation form. J Clin Psychopharmacol. 1982 Aug;2(4):245-8.
PubMed 7119132
Champlin SE, Pasch KE, Perry CL. Is the Consumption of Energy Drinks Associated With Academic Achievement Among College Students? J Prim Prev. 2016 Aug;37(4):345-59. doi: 10.1007/s10935-016-0437-4.
PubMed 27236788
Cole JS. A survey of college-bound high school graduates regarding circadian preference, caffeine use, and academic performance. Sleep Breath. 2015 Mar;19(1):123-7. doi: 10.1007/s11325-014-0976-y. Epub 2014 May 1.
PubMed 24788599
Czerniak E, Davidson M. Placebo, a historical perspective. Eur Neuropsychopharmacol. 2012 Nov;22(11):770-4. doi: 10.1016/j.euroneuro.2012.04.003. Epub 2012 May 18.
PubMed 22608298
Franzen MD, Tishelman AC, Sharp BH, Friedman AG. An investigation of the test-retest reliability of the Stroop Color-Word Test across two intervals. Arch Clin Neuropsychol. 1987;2(3):265-72.
PubMed 14589618
Geuter S, Koban L, Wager TD. The Cognitive Neuroscience of Placebo Effects: Concepts, Predictions, and Physiology. Annu Rev Neurosci. 2017 Jul 25;40:167-188. doi: 10.1146/annurev-neuro-072116-031132. Epub 2017 Apr 7.
PubMed 28399689
Hammond DC. A review of the history of hypnosis through the late 19th century. Am J Clin Hypn. 2013 Oct;56(2):174-91. doi: 10.1080/00029157.2013.826172.
PubMed 24665818
Ibrahim IR, Ibrahim MI, Al-Haddad MS. The influence of consumers' preferences and perceptions of oral solid dosage forms on their treatment. Int J Clin Pharm. 2012 Oct;34(5):728-32. doi: 10.1007/s11096-012-9667-6. Epub 2012 Jun 29.
PubMed 22744843
Kinirons MT, O'Mahony MS. Drug metabolism and ageing. Br J Clin Pharmacol. 2004 May;57(5):540-4. doi: 10.1111/j.1365-2125.2004.02096.x.
PubMed 15089805
Lessard, M. D. (1993). Study of the Velten Mood Induction Procedure and the measurement of mood. Graduate Student Theses, Dissertations, & Professional Papers. 4973. https://scholarworks.umt.edu/etd/4973
Magalhaes, S. d. S., Malloy-Diniz, L. F., & Hamdan, A. C. (2012). Validity convergent and reliability test-retest of the rey auditory verbal learning test. Clinical Neuropsychiatry: Journal of Treatments Evaluation, 9(3), 129.
Nehlig A, Daval JL, Debry G. Caffeine and the central nervous system: mechanisms of action, biochemical, metabolic and psychostimulant effects. Brain Res Brain Res Rev. 1992 May-Aug;17(2):139-70. doi: 10.1016/0165-0173(92)90012-b.
PubMed 1356551
Overgaard AB, Hojsted J, Hansen R, Moller-Sonnergaard J, Christrup LL. Patients' evaluation of shape, size and colour of solid dosage forms. Pharm World Sci. 2001 Oct;23(5):185-8. doi: 10.1023/a:1012050931018.
PubMed 11721676
Pasman WJ, Boessen R, Donner Y, Clabbers N, Boorsma A. Effect of Caffeine on Attention and Alertness Measured in a Home-Setting, Using Web-Based Cognition Tests. JMIR Res Protoc. 2017 Sep 7;6(9):e169. doi: 10.2196/resprot.6727.
PubMed 28882811

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Placebo Effect trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Tablet Size on Cognitive Performance: A Randomized Control Trial Using Caffeine
ClinicalTrials.gov ID: NCT03694886
Acronym / sponsor ID: CaC / 18-1086
Conditions: Placebo Effect
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Study start: 31 Oct 2018 (actual)
Primary completion: 1 Mar 2019 (actual)
Study completion: 1 Mar 2019 (actual)
First posted: 3 Oct 2018 (actual)
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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4
Model description: Participants will be randomly assigned to one of four groups: 1) 90 mg caffeine with a 1 mm diameter sucrose pillule; 2) no caffeine with the small sucrose pillule; 3) 90 mg caffeine with a 5 mm sucrose pillule; 4) no caffeine with the large sucrose pillule.

Arm	Type	Receives
Caffeine with small sucrose pill	Active comparator	Drug: Caffeine Anhydrous with small sucrose pillParticipants will be given one dose of 90 milligrams caffeine anhydrous dissolved in 8 ounces of water and a 1 mm sucrose pill to consume in 10 minutes. After 30 minutes post-administration, the cognitive tests will be administered.
Caffeine with large sucrose pill	Active comparator	Drug: Caffeine Anhydrous with large sucrose pillParticipants will be given one dose of 90 milligrams caffeine anhydrous dissolved in 8 ounces of water and a 5 mm sucrose pill to consume in 10 minutes. After 30 minutes post-administration, the cognitive tests will be administered.
No caffeine with small sucrose pill	Placebo comparator	Other: Placebo - small sucrose pillParticipants will be given 8 ounces of water and a 1 mm sucrose pill to consume in 10 minutes. After 30 minutes post-administration, the cognitive tests will be administered.
No caffeine with large sucrose pill	Placebo comparator	Other: Placebo - large sucrose pillParticipants will be given 8 ounces of water and a 1 mm sucrose pill to consume in 10 minutes. After 30 minutes post-administration, the cognitive tests will be administered.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Fluent in written and spoken English
Ability to see color
No uncontrolled high blood pressure
No allergies to caffeine or sucrose
No history of heart disease

Key exclusion criteria (8 listed)

Not fluent in written and/or spoken English
Uncontrolled high blood pressure
Color-blindness
Allergies to caffeine and/or sucrose
History of heart disease

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
Caffeine Anhydrous with small sucrose pillAlso: pure caffeine powdercaffeine anhydrous that has been weighed out to 90 mg per dose presented with a 1 mm sucrose pillule	Drug	Caffeine with small sucrose pill
Placebo - large sucrose pillAlso: sugar pillsucrose pillules of 5 mm diameter will be given to all participants in the large pill groups	Other	No caffeine with large sucrose pill
Caffeine Anhydrous with large sucrose pillAlso: pure caffeine powdercaffeine anhydrous that has been weighed out to 90 mg per dose presented with a 5 mm sucrose pillule	Drug	Caffeine with large sucrose pill
Placebo - small sucrose pillAlso: sugar pillsucrose pillules of 1 mm diameter will be given to all participants in the small pill groups	Other	No caffeine with small sucrose pill

Primary outcome

Stroop Color test
Time frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 1.5 minutes
Measures processing speed. 100-item, time-trial task where participants read the color of printed items on the task paper as quickly as possible for 45 seconds. Scores are measured in the number of correct responses within the allotted time.
Stroop Word test
Time frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 1.5 minutes
Measures processing speed. 100-item, time-trial task where participants read color names printed on the task paper as quickly as possible for 45 seconds. Scores are measured in the number of correct responses within the allotted time.
Trail Making task A
Time frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 2 minutes
Measures processing speed. 25 item, time-trial task where participants must connect numbers in order as quickly as possible. Scores are measured by the amount of time (in seconds) for participants to complete the task.

3 secondary outcomes

Stroop Color-and-Word test
Time frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 2 minutes
Trail Making task B
Time frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 3 minutes
Rey Auditory Verbal Learning test
Time frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 40 minutes

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 17 Apr 2019.
Background: PubMed 27762662Beaumont R, Cordery P, Funnell M, Mears S, James L, Watson P. Chronic ingestion of a low dose of caffeine induces tolerance to the performance benefits of caffeine. J Sports Sci. 2017 Oct;35(19):1920-1927. doi: 10.1080/02640414.2016.1241421. Epub 2016 Oct 20.
Background: PubMed 7119132Buckalew LW, Coffield KE. An investigation of drug expectancy as a function of capsule color and size and preparation form. J Clin Psychopharmacol. 1982 Aug;2(4):245-8.
Background: PubMed 27236788Champlin SE, Pasch KE, Perry CL. Is the Consumption of Energy Drinks Associated With Academic Achievement Among College Students? J Prim Prev. 2016 Aug;37(4):345-59. doi: 10.1007/s10935-016-0437-4.
Background: PubMed 24788599Cole JS. A survey of college-bound high school graduates regarding circadian preference, caffeine use, and academic performance. Sleep Breath. 2015 Mar;19(1):123-7. doi: 10.1007/s11325-014-0976-y. Epub 2014 May 1.
Background: PubMed 22608298Czerniak E, Davidson M. Placebo, a historical perspective. Eur Neuropsychopharmacol. 2012 Nov;22(11):770-4. doi: 10.1016/j.euroneuro.2012.04.003. Epub 2012 May 18.
Background: PubMed 14589618Franzen MD, Tishelman AC, Sharp BH, Friedman AG. An investigation of the test-retest reliability of the Stroop Color-Word Test across two intervals. Arch Clin Neuropsychol. 1987;2(3):265-72.
Background: PubMed 28399689Geuter S, Koban L, Wager TD. The Cognitive Neuroscience of Placebo Effects: Concepts, Predictions, and Physiology. Annu Rev Neurosci. 2017 Jul 25;40:167-188. doi: 10.1146/annurev-neuro-072116-031132. Epub 2017 Apr 7.
Background: PubMed 24665818Hammond DC. A review of the history of hypnosis through the late 19th century. Am J Clin Hypn. 2013 Oct;56(2):174-91. doi: 10.1080/00029157.2013.826172.
Background: PubMed 22744843Ibrahim IR, Ibrahim MI, Al-Haddad MS. The influence of consumers' preferences and perceptions of oral solid dosage forms on their treatment. Int J Clin Pharm. 2012 Oct;34(5):728-32. doi: 10.1007/s11096-012-9667-6. Epub 2012 Jun 29.
Background: PubMed 15089805Kinirons MT, O'Mahony MS. Drug metabolism and ageing. Br J Clin Pharmacol. 2004 May;57(5):540-4. doi: 10.1111/j.1365-2125.2004.02096.x.
BackgroundLessard, M. D. (1993). Study of the Velten Mood Induction Procedure and the measurement of mood. Graduate Student Theses, Dissertations, & Professional Papers. 4973. https://scholarworks.umt.edu/etd/4973
BackgroundMagalhaes, S. d. S., Malloy-Diniz, L. F., & Hamdan, A. C. (2012). Validity convergent and reliability test-retest of the rey auditory verbal learning test. Clinical Neuropsychiatry: Journal of Treatments Evaluation, 9(3), 129.
Individual participant dataSharing planned: No

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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.

Daniel Hernandez Altamirano principal investigator

Undergraduate honors student

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 8 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 17 Apr 2019. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Stroop Color test (time frame: Within 90 minutes of receiving informed consent. Actual task time: approximately 1.5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03694886, which also lists 19 linked publications.

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 17 Apr 2019.