Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05778591
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-02-28
Brief Title:
Low-dose Buprenorphine as a Modulator of Social Motivation in Schizophrenia
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Low-dose Buprenorphine as a Modulator of Social Motivation in Schizophrenia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Low social motivation is a significant symptom of schizophrenia and is a major cause of disability and suffering for many patients struggling with the illness Social motivation refers to the drive to participate in or abstain from social activities Many patients with schizophrenia evidence both decreased drive to seek positive social input approach motivation and heightened drive to avoid negative social input avoidance motivation compared to individuals without the illness Despite the enormous burden of these deficits on patients there are no medications that effectively treat impaired social motivation Buprenorphine is an unusual drug that is used to treat opioid use disorder at higher doses and more recently to treat depression and suicidality at lower doses It is a unique opioid medication that has a compound action that gives it the potential to improve social motivation both by boosting approach motivation and by reducing avoidance motivation The effects of low doses of buprenorphine have previously been studied in healthy volunteers showing that the drug enhances social motivation These results in nonclinical volunteers suggest that buprenorphine may be a promising treatment for deficits in social motivation seen in some patients with schizophrenia However no previous studies have investigated the effects of buprenorphine on social motivation in this population Here the effects of a low dose of buprenorphine 015mg on social motivation in patients with schizophrenia N40 will be assessed In this double-blind cross-over placebo-controlled study participants will attend a 2-hour preparatory session and two 6-hour laboratory sessions at which they will receive either placebo or buprenorphine During expected peak drug effect they will complete validated tasks assessing social motivation It is expected that buprenorphine will increase approach motivation and decrease avoidance motivation as measured by an attention bias task The results of this study will lay the foundation for the clinical use of buprenorphine as the first medication to treat social deficits in schizophrenia
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None