Oxytocin and Cognitive Control in Adult ADHD
Purpose
This is a randomized, double-blind, placebo-controlled crossover study of single-dose intranasal oxytocin (24 IU) in 18-55 year-old men with attention deficit/hyperactivity disorder (ADHD). Following a screening visit to determine eligibility, participants will return for two main study visits. During the main study visits, study participants will receive either oxytocin (Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland) or placebo (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy), followed by assessments of cognitive control over attention and behavior. Twenty-four participants will be randomized 1:1 to one of two drug orders, i.e., oxytocin - placebo or placebo - oxytocin. In an additional neuroimaging substudy, a subset of participants will undergo task-based and resting-state functional magnetic resonance imaging (fMRI) following oxytocin/placebo administration to investigate the effects of oxytocin on fMRI activation and functional connectivity within the cognitive control network.
Condition
- Attention Deficit/Hyperactivity Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male - 18-55 years - Diagnosis of attention deficit/hyperactivity disorder
Exclusion Criteria
- History of cardiovascular disease (e.g., hypertrophic cardiomyopathy, valvular heart disease, coronary heart disease, or coronary artery spasms) - History of diabetes mellitus - Untreated thyroid disease - Hematocrit below the normal range - Tobacco use - Any other significant illness or condition that the investigator determines could interfere with study participation or safety or put the subject at any unnecessary risk - Excluded at the investigator's clinical judgement of ADHD symptom severity
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Drug order: Oxytocin - placebo |
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Experimental Drug order: Placebo - oxytocin |
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More Details
- Status
- Completed
- Sponsor
- Massachusetts General Hospital