Status:
UNKNOWN
Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy
Lead Sponsor:
InCaveo
Conditions:
Pain, Postoperative
Analgesics, Opioid
Eligibility:
All Genders
55-85 years
Phase:
NA
Brief Summary
The clinical study described in this Clinical Investigation Plan (CIP) will be completed in two stages, Phase I and Phase II. The results of Phase I will confirm patient use of InCaveo's EOA system wi...
Detailed Description
The InCaveo End Opioid Addiction (EOA) System is an integrated pain management therapeutic and opioid tapering system providing alternate treatment options via self-service Cognitive Behavior Therapy ...
Eligibility Criteria
Inclusion
- Patient has a Pain Catastrophizing Score \>16
- 55 years of age and older.
- English speaking.
- Has a smartphone (iPhone).
- Able to swallow oral medications.
- No continuous daily opioid as defined as more than 15 days in the 30 days before surgery.
- Undergoing TKR surgery.
- Patients who are willing and able to comply with scheduled visits and study procedures.
Exclusion
- Diagnosed with Opioid Use Disorder (OUD).
- Actively using illicit drugs.
- Allergy to opioids
- Older than 85 years
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04836169
Start Date
October 1 2021
End Date
May 1 2022
Last Update
April 8 2021
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