Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419439
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-04-23
Brief Title:
Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression
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:
This is a pilot study to evaluate the feasibility acceptability and safety of ketamine infusions followed by a brief behavioral intervention in Veterans with chronic low back pain and depression
Detailed Description:
Chronic low back pain CLBP and depression are top causes of disability in the United States Veterans are more likely to have both prevalence is increasing When CLBP and depression occur together patients report more functional limitations unemployment and higher healthcare spending and treatment is less successful Novel approaches simultaneously addressing pain interference and depression symptoms are needed
This study will involve initial pilot feasibility testing of an intervention designed to help participants with chronic low back pain and depression both reduce pain interference and improve mood This study will occur in two phases The initial phase is a open-label single-arm pilot of the combined intervention ketamine infusions followed by the brief behavioral intervention in a small sample of Veterans n5 The objective is to develop and assess initial feasibility of study procedures and obtain participant feedback through semi-structured exit interviews The second phase consists of a single-blind two-arm pilot feasibility randomized controlled trial RCT n44 22 per arm which will a assess feasibility benchmarks and b collect outcome data that will be used to calculate sample size to power a larger RCT
This study will involve initial pilot feasibility testing of an intervention designed to help participants with chronic low back pain and depression both reduce pain interference and improve mood This study will occur in two phases The initial phase is a open-label single-arm pilot of the combined intervention ketamine infusions followed by the brief behavioral intervention in a small sample of Veterans n5 The objective is to develop and assess initial feasibility of study procedures and obtain participant feedback through semi-structured exit interviews The second phase consists of a single-blind two-arm pilot feasibility randomized controlled trial RCT n44 22 per arm which will a assess feasibility benchmarks and b collect outcome data that will be used to calculate sample size to power a larger RCT
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IK2CX002646-01A2 | OTHER_GRANT | CSRD | None |