Clinical trial
Methylphenidate and Response to Alcohol Cues (MARA) Pilot Study
Name
IRB202301428
Description
The purpose of this study is to determine whether changes in attention levels related to taking a single dose of a medication called methylphenidate, also known as Ritalin, affects responses to alcohol cues. The study will observe the effects of methylphenidate or a placebo on attentional bias and craving responses to alcohol cues through fMRI, EEG, and behavioral testing. Participants will be involved in one remote and two in-person sessions.
Trial arms
Trial start
2024-03-20
Estimated PCD
2025-06-01
Trial end
2025-06-01
Status
Recruiting
Phase
Early phase I
Treatment
Methylphenidate Pill
Single encapsulated pill
Arms:
crossover 1: methylphenidate, placebo, crossover 2: placebo, methylphenidate
Other names:
Ritalin
Size
30
Primary endpoint
Neural responses to cues
15 minutes
Self-reported craving
15 minutes
Accuracy on the attentional blink task
5 minutes
Eligibility criteria
Inclusion Criteria:
* Adults ages 18-25 years
* Meets DSM-5 criteria for AUD
* Meets DSM-5 criteria for ADHD
* Fluent in English
* Normal or corrected to normal vision
Exclusion Criteria:
* Meets DSM-5 criteria for bipolar disorder, psychotic disorders, neurological disorders, or substance use disorders other than AUD.
* Participant routinely uses psychoactive drugs or medications except for non-dependent marijuana or nicotine use (due to common use of these substances in individuals with AUD).
* Participant has contraindications for taking methylphenidate.
* Participant has contraindications for being in an MRI machine
* Self-reported history of high blood pressure over 140/90 or consistent readings of 140/90 or above upon arrival for a session.
* History of seizure disorder
* Liver disease
* Participant is currently pregnant or trying to become pregnant
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-05-02
1 organization
1 product
2 indications
Organization
University of FloridaProduct
MethylphenidateIndication
Alcohol Use DisorderIndication
ADHD