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

Indication
ADHD