NCT05325502

Brief Summary

"Learning from the rewards" is underlying the formulation of knowledge and habits in daily life. Caffeine is the most commonly used "psychoactive" substance that could change one's mind state by affecting the brain and nervous system. By such effects, caffeine enhances reward signals - dopamine - in human brains. In this research study, we will find out whether taking caffeine acutely or daily can enhance reward learning processes.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
May 2022Dec 2026

First Submitted

Initial submission to the registry

March 28, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

May 5, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3.7 years

First QC Date

March 28, 2022

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • The accuracy (% of correct answers) in implicit learning through different probabilities of monetary reward feedback

    Through a probabilistic selection task, participant will go through a training phase to learn the rules which options may be more likely to return monetary feedback, and the knowledge learned will be tested in a second phase where the task difficulty is increased, and no feedback is provided. The overall accuracy in the testing phases will be examined, as well as the accuracies in choosing or avoiding the highest and lowest reward-probability stimuli.

    1-hour after the second intake on the 7th day

Secondary Outcomes (2)

  • The errors in motor inhibition (rates of false alarm) in a motor inhibition task

    1.5-hour after the second intake on the 7th day

  • Salience attribution behaviors

    1.5-hour after the second intake on the 7th day

Other Outcomes (4)

  • Self-report anxiety levels

    1-hour after the second intake on the 7th day

  • Subjective sleepiness and alertness

    1-hour after the second intake on the 7th day

  • heart rate measurement

    1-hour after the second intake on the 7th day

  • +1 more other outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

7 days placebo intake.

Dietary Supplement: mannitol

Acute caffeine

ACTIVE COMPARATOR

6 days placebo followed by 1 day caffeine intake.

Dietary Supplement: caffeineDietary Supplement: mannitol

Daily caffeine

EXPERIMENTAL

7 days caffeine intake

Dietary Supplement: caffeine

Interventions

caffeineDIETARY_SUPPLEMENT

two doses per day: 200 mg caffeine in the morning; 100 mg caffeine in the afternoon

Acute caffeineDaily caffeine
mannitolDIETARY_SUPPLEMENT

two doses per day: 200 mg in the morning \& 100 mg in the afternoon

Acute caffeinePlacebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≥ 18 and ≤ 40
  • Clinically healthy
  • Non-smokers

You may not qualify if:

  • Habitual caffeine intake \< 100 mg or \> 450 mg
  • Pregnant or lactating women
  • Women using hormonal contraceptives
  • BMI \< 18.5 or \> 29.9
  • Sleep disturbance or extreme chronotypes
  • Nicotine or recreational drug users
  • Depression, anxiety, psychosis, or neurologic disorders
  • Severe heart or cardiovascular diseases
  • Diabetes or metabolic diseases
  • Under chronic medications
  • Incapable to operate the tasks or comprehend the study information in German or English
  • Users of the Bopomo alphates utilized as stimuli in the reward learning tasks
  • Current enrolment in other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Chronobiology, University Psychiatric Clinics Basel

Basel, Canton of Basel-City, CH-4002, Switzerland

Location

MeSH Terms

Interventions

CaffeineMannitol

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Yu-Shiuan Lin, PhD

    Centre for Chronobiology, University Psychiatric Clinics Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Postdoc researcher

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 13, 2022

Study Start

May 5, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

IPD data, including SAP, CSR, and analytic codes, will be made available on OSF or provided upon requests after the data requested are published.

Shared Documents
STUDY PROTOCOL, CSR, ANALYTIC CODE
Time Frame
Data will be made available after publishing (estimated to be July 2023).
Access Criteria
Researchers who are interested in using IPD data from ADoRe can either contact the Sponsor-Investigator (ys.lin@unibas.ch, Yu-Shiuan Lin, PhD) or access from ADoRe project on OSF (https://osf.io/wzf2y/). Please note that the data folder of this project will be only accessible after publishing.

Locations