The Effect of Tablet Size on Cognitive Performance Caffeine (CaC)

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 4

Conditions: Placebo Effect

Treatments: Drug: Caffeine Anhydrous with large sucrose pill; Other: Placebo - small sucrose pill; Drug: Caffeine Anhydrous with small sucrose pill; Other: Placebo - large sucrose pill

Study type: Interventional

Funder types: Other

Identifiers

NCT03694886

18-1086

Details and patient eligibility

About

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 caffeine with a 5 mm sucrose pillule; 4) no caffeine with the large sucrose pillule.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups, including a placebo group

Caffeine with small sucrose pill

Active Comparator group

Description:

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.

Treatment:

Drug: Caffeine Anhydrous with small sucrose pill

Caffeine with large sucrose pill

Active Comparator group

Description:

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.

Treatment:

Drug: Caffeine Anhydrous with large sucrose pill

No caffeine with small sucrose pill

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo - small sucrose pill

No caffeine with large sucrose pill

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo - large sucrose pill