Effects of Caffeine on Reinforcement Learning in Healthy Adults Using PET/MRI

NCT ID: NCT06763172

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-17

Study Completion Date

2026-12-31

Brief Summary

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This research study aims to determine whether and how caffeine intake affects learning process through reward feedback compared to placebo. The data acquired from this study would improve our understanding on the consequence and mechanism of caffeine intake in the aspect of learning process.

Participants will perform a reinforcement learning task (i.e. Probabilistic Selection Task) and a motor inhibition task (i.e. Go/NoGo task) in a brain scan. The scan will be done with the Siemens Biograph mMR positron emission tomography (PET)/ magnetic resonance imaging (MRI) 3 Tesla scanner. The PET allows us to see the changes in the "reward signals" - dopamine - in the brain using a radioactive dye called \[11C\]Raclopride. The MRI, on the other hand, enables us to take detailed pictures of the brain activities during cognitive tasks using a high-powered magnet. Reviewing these pictures will help us understand the influence of caffeine on reward signals and brain activities during the learning process.

Detailed Description

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Adenosine 2A receptors (A2AR) colocalize with and exerts allosteric antagonism to dopamine D2 receptors (D2R) by co-forming functional heterodimers in the striatum. Preliminary studies using positron emission tomography (PET) with \[11C\]Raclopride have shown increased D2/D3R availability by A2AR antagonism with caffeine and decreased D2/D3R availability by enhanced adenosine signaling during sleep deprivation, supporting the notion of A2AR-D2R interactions in vivo. However, how A2AR-D2R interactions contribute to D2R-mediated neurocognitive functions is scarcely investigated.

Reinforcement learning, a dopamine-mediated cognitive process crucially involved in various human behaviors including habit, preference, belief, and resistance to change, is often found altered in dopamine-associated disorders. For instance, hyper-dopaminergic function in the striatum, as observed in psychosis, leads to a reduction in reward learning and a blunted task-related neural activity. Through the antagonistic effect of A2AR on D2R signaling, blocking A2AR can potentially enhance D2R-mediated negative reinforcement, a.k.a. a "no-go" response. In rodents, A2AR agonists diminish reinforcement of psychostimulants, while an A2AR antagonist can facilitate reward-seeking effects of reinforcers. Hence, in this double-blind randomized crossover study, the investigators aim to use caffeine, an adenosine antagonist as well as a commonly used psychostimulant by nearly 80% of the worldwide population, to examine whether blocking A2AR will enhance D2R-modulated reinforcement learning/no-go responses through modulating D2R signaling pharmacologically.

The long-term goal of this study is to further the understanding of molecular mechanisms related to A2AR-D2R heterodimers and the clinical potential of modulating A2AR-D2R interactions. Twelve young healthy non-smokers will enroll in this study. Each participant will undergo a caffeine and a placebo condition. In each condition, participants will first go through a 6-day ambulatory washout period where participants will be asked to abstain from caffeinated dietary, alcohol, and drugs, and stay in regular bed- and wakeup time. On day 7, a PET/fMRI scan will take place at noon, and a caffeine or placebo tablet will be administered orally 20 mins prior to the scan.

Simultaneous PET/fMRI will be used to examine the association between the neurochemical changes (i.e., D2/D3R availability as quantified by \[11C\]Raclopride) and the hemodynamic responses (i.e., task-related blood oxygen level-dependent fMRI activity) during reinforcement learning in the caffeine condition compared to placebo. It is hypothesized that enhanced D2/D3R availability mediates the facilitating effect of caffeine on reinforcement learning. Specifically, the investigators expect that caffeine will enhance fMRI responses in reward-related brain regions, and that the increased fMRI response will positively correlate with a change in D2/D3R availability.

Conditions

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Healthy Caffeine Adenosine Dopamine D2/3 Receptor Availability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Caffeine

Caffeine tablet, 200mg

Group Type EXPERIMENTAL

Caffeine (200 mg)

Intervention Type DRUG

Caffeine (200mg) will be administered per os 20 minutes prior to the PET/fMRI data acquisition.

Placebo

Lactose tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Lactose tablet will be administered per os 20 minutes prior to the PET/fMRI data acquisition.

Interventions

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Caffeine (200 mg)

Caffeine (200mg) will be administered per os 20 minutes prior to the PET/fMRI data acquisition.

Intervention Type DRUG

Placebo

Lactose tablet will be administered per os 20 minutes prior to the PET/fMRI data acquisition.

Intervention Type DRUG

Other Intervention Names

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Lactose

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 and ≤ 45.
* Habitual caffeine intake ≥ 100 mg and ≤ 450 mg daily.
* Non-smokers.
* Clinically healthy.
* Have normal vision or corrected to normal vision.

Exclusion Criteria

* Pregnant or lactating women.
* Women using hormonal contraceptives.
* BMI \< 18.5 or \> 29.9
* Sleep disturbance or extreme chronotype.
* Urine test positive on one of the following substances: benzoylecgonine, morphine, d-Methamphetamine, d-Amphetamine, Benzodiazepines, Secobarbital, Methadone, Buprenorphine Glucuronide, Nortriptyline, MDMA, Oxycodone, PCP, Propoxyphene, and Cannabis/THC
* Diagnosis of depression, anxiety, psychosis, or neurologic disorders in the last 5 years.
* Heart or cardiovascular diseases.
* Diabetes or other metabolic diseases.
* Under chronic medications, for instance, painkiller and steroid.
* Allergy to lactose (main ingredient of blank control dose)
* Incapable to operate the tasks or comprehend the study information in English.


* Metallic foreign bodies such as cardiac pacemakers, perfusion pumps, aneurysm clips, metallic tattoos anywhere on the body, tattoos near the eye.
* Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions
* Inability to lie flat on scanner bed for about 90 min as assessed by physical examination and medical history (e.g. arthritis)
* Recent exposure to radiation (i.e., PET from other research studies) that, when combined with this study, would be above the allowable limits
* Pregnancy or breastfeeding: A negative serum or urine pregnancy test is required on the day of the PET procedure
* Body weight of \> 300 lbs (weight limit of the MRI scanner table)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hsiao-Ying Wey

OTHER

Sponsor Role lead

Responsible Party

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Hsiao-Ying Wey

Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Athinoula A. Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Hsiao-Ying Wey, PhD

Role: CONTACT

6177241384

Facility Contacts

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Hsiao-Ying Wey, PhD

Role: primary

617-724-1384

Role: backup

Hsiao-Ying Wey, PhD

Role: backup

Yu-Shiuan Lin, PhD

Role: backup

References

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Bedingfield JB, King DA, Holloway FA. Cocaine and caffeine: conditioned place preference, locomotor activity, and additivity. Pharmacol Biochem Behav. 1998 Nov;61(3):291-6. doi: 10.1016/s0091-3057(98)00092-6.

Reference Type BACKGROUND
PMID: 9768563 (View on PubMed)

Moran EK, Culbreth AJ, Kandala S, Barch DM. From neuroimaging to daily functioning: A multimethod analysis of reward anticipation in people with schizophrenia. J Abnorm Psychol. 2019 Oct;128(7):723-734. doi: 10.1037/abn0000461. Epub 2019 Aug 29.

Reference Type BACKGROUND
PMID: 31464449 (View on PubMed)

Volkow ND, Wang GJ, Telang F, Fowler JS, Logan J, Wong C, Ma J, Pradhan K, Tomasi D, Thanos PK, Ferre S, Jayne M. Sleep deprivation decreases binding of [11C]raclopride to dopamine D2/D3 receptors in the human brain. J Neurosci. 2008 Aug 20;28(34):8454-61. doi: 10.1523/JNEUROSCI.1443-08.2008.

Reference Type BACKGROUND
PMID: 18716203 (View on PubMed)

Kaasinen V, Aalto S, Nagren K, Rinne JO. Dopaminergic effects of caffeine in the human striatum and thalamus. Neuroreport. 2004 Feb 9;15(2):281-5. doi: 10.1097/00001756-200402090-00014.

Reference Type BACKGROUND
PMID: 15076753 (View on PubMed)

Volkow ND, Wang GJ, Logan J, Alexoff D, Fowler JS, Thanos PK, Wong C, Casado V, Ferre S, Tomasi D. Caffeine increases striatal dopamine D2/D3 receptor availability in the human brain. Transl Psychiatry. 2015 Apr 14;5(4):e549. doi: 10.1038/tp.2015.46.

Reference Type BACKGROUND
PMID: 25871974 (View on PubMed)

Ferre S, Bonaventura J, Tomasi D, Navarro G, Moreno E, Cortes A, Lluis C, Casado V, Volkow ND. Allosteric mechanisms within the adenosine A2A-dopamine D2 receptor heterotetramer. Neuropharmacology. 2016 May;104:154-60. doi: 10.1016/j.neuropharm.2015.05.028. Epub 2015 Jun 4.

Reference Type BACKGROUND
PMID: 26051403 (View on PubMed)

Other Identifiers

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1R21MH138923-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB2022P001681

Identifier Type: -

Identifier Source: org_study_id

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