Deciphering the Role of Oxytocin in Motivation: an fMRI Study. Part II
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|ClinicalTrials.gov Identifier: NCT02652195|
Recruitment Status : Recruiting
First Posted : January 11, 2016
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy Controls Alcohol Use Disorder||Drug: Placebo Drug: Oxytocin||Phase 2|
Oxytocin is a well-known social and reproductive hormone demonstrated to have a variety of prosocial effects in humans including enhancing trust and generosity, improving positive communication, increasing eye gaze, and reducing anxiety. Oxytocin is hypothesized to facilitate social behaviors via its modulation of motivational networks. With this study, the investigators will characterize oxytocin's effects on the neural processing of salient stimuli. The investigators will utilize a noninvasive brain imaging technique, functional magnetic resonance imaging (fMRI), to assess brain activity while participants perform tests designed to engage neural circuits associated with the processing of social and non-social stimuli.
Ongoing clinical trials are examining the use of intranasal oxytocin for the treatment of multiple psychiatric disorders including substance dependence, depression, and schizophrenia; disorders which reward system dysfunction appears to play a significant role. As such, it is important that we obtain a better understanding of the neurobiological effects this drug may have on reward circuitry functioning. To this end, in this study, we will examine healthy control participants and participants diagnosed with Alcohol Use Disorder (AUD).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Deciphering the Role of Oxytocin in Motivation: an fMRI Study. Part II|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
Placebo Comparator: Placebo
Each participant will be studied using fMRI following self-administration of placebo.
Placebo intranasal administration, 3 puffs per nostril, delivered prior to scanning session.
Each participant will be studied using fMRI following self-administration of oxytocin.
Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff, delivered prior to scanning session.
- Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment: Control group [ Time Frame: Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1) ]
- Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment: AUD Group [ Time Frame: Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1) ]
- Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. AUD vs Controls [ Time Frame: Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652195
|Contact: Bryan Crumemail@example.com|
|United States, Utah|
|University Neuropsychiatric Institute - University of Utah HealthCare||Recruiting|
|Salt Lake City, Utah, United States, 84108|
|Contact: Bryan Crum 801-587-8972 firstname.lastname@example.org|
|Principal Investigator:||Tiffany Love, PhD||University of Utah|