Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-09
Brief Title:
Intervening on Opioid Use and Loneliness
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Addressing Loneliness as a Therapy Target Among Individuals Using Opioids
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
This study aims to enroll 300 participants who will be assigned to one of three 3 groups Each group will receive an intervention lasting 6 weekly sessions of 40-60 minutes Eligibility include having an opioid use disorder and reporting loneliness or feeling alone or disconnected
Detailed Description:
Individuals n 300 with an opioid use disorder reporting loneliness will be randomized to either 1 therapist-delivered cognitive-behavioral therapy for perceived social isolation 2 therapist-delivered Health Education or 3 self-guided Health Education Loneliness opioid and other substance use the amount of social interactions social support and mental and physical health factors prior to starting the treatment after completing the treatment and 1 3 and 6 months following the treatment will be assessed to see how well they work compared to each other
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None