Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543355
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
The Acupuncture for Pain Opioid Use Disorder and Mood
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Acupuncture for Pain Opioid Use Disorder and Mood AcuPOM Study A Pilot Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AcuPOM
Brief Summary:
The goal of this study is to determine how patients with chronic pain and opioid use disorder will respond to treatment with acupuncture including whether there will be any changes in mood Results from this study have the potential to inform future studies in patients who would consider using acupuncture as an intervention for their conditions
Detailed Description:
In this 4-week pilot study the feasibility of recruiting a sample of participants in a modified Battlefield Acupuncture National Acupuncture Detoxification Association BFA NADA protocol will be assessed Utilizing a novel BFA Battlefield Acupuncture plus a NADA National Acupuncture Detoxification Association protocol approximately 20 participants with chronic pain and Opioid Use Disorder OUD receiving Methadone through an Opioid Treatment Program OTP at Montefiore Medical Center will be recruited Each participant will receive a modified BFA NADA treatment twice per week over 4 weeks for a total of 8 treatments at the clinic All participants will also have the small seeds placed to facilitate at-home acupressure treatment In this feasibility study the investigator team will collect feasibility data from each participant at every session over the course of 4 weeks Feasibility outcomes are defined in the Outcome Measures of this registration As part of the study the following will also be monitored to explore preliminary efficacy 1 pain intensity and physical functioning 2 opioid cravings and substance use and 3 mood insomnia and stress The research team will conduct surveys assessing pain physical functions the changes in stress mood insomnia and psychological changes at baseline and before and after every treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None