NCT04963972

Digital and Behavioral Tele-Health Tapering Program for Lowering Dependence on Opioids in Patients Undergoing Surgery

Impact of Digital and Behavioral Tele-Health Tapering Program for Perioperative Surgical Patients Exposed to Opioids

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 272 (estimated)
• Sponsor: Lucid Lane, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies the effect of behavioral health support including tele-health in helping surgical patients taper off of prescription opioid pain medications. "Tapering off" means taking dose amounts of medication that get smaller over time, so that less and less of the drug is used until it is not needed anymore. Researchers want to learn how these techniques may improve a patient's ability to lower or avoid dependence on opioid medications after surgery, and if behavioral therapies may improve quality of life, emotional well-being, and functional status around surgery.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the impact of Lucid Lane's perioperative opioid tapering program utilizing daily behavioral health support (Health Insurance Portability and Accountability Act \[HIPAA\]-compliant sessions of cognitive behavioral therapy \[CBT\], mindfulness, 1:1 psychotherapy, group therapy, and 2-way texting and chat, all interactions with Lucid Lane licensed therapists), for patients who are on an opioid medication prior to surgery (tolerant), or naive and will be undergoing a surgery with curative intent post-surgery. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients participate in the Lucid Lane therapy program including working with a mental health therapist on mindfulness, CBT, group therapy, and mind-body therapies for 3-9 months or until the tapering off period is complete. ARM II: Patients receive standard of care post-surgical opioid education.

Conditions

• Malignant Abdominal Neoplasm
• Malignant Head and Neck Neoplasm
• Malignant Solid Neoplasm
• Malignant Thoracic Neoplasm

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Intervention	Participate in Lucid Lane therapy program
OTHER	Best Practice	Receive standard of care opioid education
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2021-02-23
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2021-07-15
• Last updated: 2022-05-10

Locations

1 site across 1 country: United States