Clinical trial NCT06063200: Methylphenidate and Response to Alcohol Cues
Official title: Methylphenidate and Response to Alcohol Cues (MARA) Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Alcohol Use Disorder
Attention Deficit Hyperactivity Disorder
Keywords: fMRI
EEG
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: Recent studies have revealed a robust link between attentional ability and resilience against stress-related psychopathology, in general, and against alcohol use disorder (AUD) specifically. For example, self-reported attentional ability correlates with scales of psychological resilience and with lower alcohol misuse in at-risk individuals. One mechanism by which attention may relate to resilience in AUD is through its effects on alcohol cue reactivity. Exposure to alcohol cues can induce motivation to drink alcohol for those with AUD. Leveraging the high rates of co-morbidity of AUD and attention-deficit/hyperactivity disorder, this pilot study seeks to demonstrate whether experimentally enhancing attention in individuals with both AUD and attentional deficits associated with attention-deficit/hyperactivity disorder (ADHD) reduces markers of addiction severity (i.e., craving and attentional bias responses to alcohol cues) and will explore the neural and behavioral mechanisms. Methylphenidate not only improves sustained attention, but in users of cocaine and methamphetamine, it was previously shown to reduce craving, attentional bias, and neural responses to viewing drug-related cues. Here we will use this commonly-prescribed medication as a pharmacological probe of attentional processes related to alcohol use disorder. We hypothesize that acute methylphenidate-associated attentional enhancement will engage compensatory brain mechanisms that will lead to attenuated craving, reduced attentional bias, and modulated neural responses to alcohol cues in young adults with AUD and ADHD. Thirty young adults with AUD and ADHD will be recruited for a double-blind, placebo-controlled, within-subjects experiment to test the effects of an acute 20 mg MPH administration to increase attention on cue-induced alcohol craving \[during simultaneous functional magnetic resonance imaging (fMRI) and EEG\] and attentional bias. Subjects will also perform computerized tasks of general attention with non-alcohol-related stimuli. The goal of this project is to support the design and funding proposal of a larger study.

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

Primary outcomes:
measure: Neural responses to cues
timeFrame: 15 minutes
measure: Self-reported craving
timeFrame: 15 minutes
measure: Accuracy on the attentional blink task
timeFrame: 5 minutes
Secondary outcomes:
measure: Self-reported anxiety
timeFrame: 15 minutes
measure: Continuous performance task omission errors
timeFrame: 5 minutes
measure: Attention network task reaction times
timeFrame: 15 minutes
measure: Heart rate
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References: