MARA
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StatusAccepting Candidates
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Age18 Years - 25 Years
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SexesAll
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Healthy VolunteersAccepts Healthy Volunteers
Objective
The purpose of this study is to determine whether changes in attention levels related to taking a single dose of a medication called methylphenidate 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.
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.
Details
| Full study title | Methylphenidate and Response to Alcohol Cues (MARA) pilot study |
| Protocol number | OCR44652 |
| ClinicalTrials.gov ID | NCT06063200 |
| Phase | Pilot |
Eligibility
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
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
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Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.