Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04650841
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-28
First Post:
2020-11-17
Brief Title:
The Role of the Opioid System in Placebo Effects on Pain and Social Rejection
Sponsor:
Trustees of Dartmouth College
Organization:
Trustees of Dartmouth College
Study Overview
Official Title:
The Role of the Opioid System in Placebo Effects on Pain and Social Rejection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
The current study probes the involvement of the opioid system in placebo effects on social pain using the opioid antagonist naloxone 60 participants who recently experienced an unwanted breakup will experience rejection-related stimuli and receive painful heat and pressure stimuli during fMRI scanning Participants will be randomized to receive either a naloxone or saline nasal spray and be informed that the spray is either saline or an effective pain and negative emotion reducing agent
Detailed Description:
Background
Loss of close relationships is one of the most aversive life events An unwanted romantic breakup leads to a 20 risk of developing depression within a month a dramatic increase in depression risk The investigators recently identified brain pathways mediating placebo effects on physical heat pain and the social pain associated with an unwanted breakup including common involvement of dlPFC-PAG pathways and vmPFC Other recent studies have identified rejection-related opioidergic activity in these circuits that may reflect endogenous regulatory mechanisms This experiment probes the involvement of the opioid system in placebo effects on social pain using the opioid antagonist naloxone
Design
Extending the investigators previous design participants who recently experienced an unwanted breakup will submit pictures of their ex-partners places associated with strong memories of the partner and written descriptions of memories that evoke rejection and social pain Participants will 1 experience rejection-related stimuli and 2 receive painful heat and pressure stimuli in separate runs during fMRI scanning FMRI scans after Control and Placebo treatment-nasal spray with suggestions of efficacy for emotion and pain-will be performed in a 2-session within-person counterbalanced design Participants will be randomized into two groups that receive either 1 4mg naloxone nasal spray or 2 saline in the nasal spray in both sessions implementing a 2 x 2 PlaceboControl x SalineNaloxone design
Loss of close relationships is one of the most aversive life events An unwanted romantic breakup leads to a 20 risk of developing depression within a month a dramatic increase in depression risk The investigators recently identified brain pathways mediating placebo effects on physical heat pain and the social pain associated with an unwanted breakup including common involvement of dlPFC-PAG pathways and vmPFC Other recent studies have identified rejection-related opioidergic activity in these circuits that may reflect endogenous regulatory mechanisms This experiment probes the involvement of the opioid system in placebo effects on social pain using the opioid antagonist naloxone
Design
Extending the investigators previous design participants who recently experienced an unwanted breakup will submit pictures of their ex-partners places associated with strong memories of the partner and written descriptions of memories that evoke rejection and social pain Participants will 1 experience rejection-related stimuli and 2 receive painful heat and pressure stimuli in separate runs during fMRI scanning FMRI scans after Control and Placebo treatment-nasal spray with suggestions of efficacy for emotion and pain-will be performed in a 2-session within-person counterbalanced design Participants will be randomized into two groups that receive either 1 4mg naloxone nasal spray or 2 saline in the nasal spray in both sessions implementing a 2 x 2 PlaceboControl x SalineNaloxone design
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