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Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids and Benzodiazepines.

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Elective Spine Surgery Receiving Pre and/or Postoperative Pain Control With Opioids

Treatments

Behavioral: Opioid and Benzodiazepine Naive-patients
Behavioral: Opioid and Benzodiazepine Tolerant-patients

Study type

Interventional

Funder types

Other

Identifiers

NCT04787692
HSC-MS-20-0549

Details and patient eligibility

About

The purpose of this study is to examine the safety, acceptability, and feasibility of a controlled taper off of opioids and/or benzodiazepines, with the use of behavioral health tele-health based therapy services, in the perioperative patient.

Enrollment

150 patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Preoperative benzodiazepines opioid dependence (daily use of opioids or benzodiazepines preoperatively) (Naive: No Meds 30 Days Prior to surgery,Opioid tolerant/dependant: Use of Meds on Most Days For 1 or more months prior to surgery)
  • Subject willing to use Lucid Lane program to provide behavioral health support perioperative period up to 6 months post-op for tolerant opioid/benzo users
  • Subject is willing to discuss Lucid Lane progress with the University of Texas Health Science Center(UTHealth) perioperative team and prescribing clinicians
  • Subject is willing to sign a Lucid Lane Client Agreement
  • Willing to sign an informed consent

Exclusion criteria

  • Serious mental illnesses including schizophrenia-spectrum disorders, severe bipolar disorder, and severe major depression.
  • Active suicidal ideations
  • Patients on methadone or buprenorphine for treatment of opioid use disorder (i.e. for treatment of addiction, and not for treatment of pain)
  • Patient unwilling to use or not possessing access to a device that allows for video visits (e.g. a smartphone, tablet, or computer)
  • Patients who are on palliative care
  • Insufficient ability to use English to participate in the consent process, the intervention or study assessments.
  • Insufficient ability to provide informed consent to participate
  • If the patient misses more than 2 lucid lane sessions per week, the staff will be immediately notified by Lucid Lane.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Opioid and Benzodiazepine Naive-patients
Experimental group
Description:
Opioid and Benzodiazepine Naive-patients, defined as no medications 30 days prior to surgery
Treatment:
Behavioral: Opioid and Benzodiazepine Naive-patients
Opioid and Benzodiazepine Tolerant-patients
Experimental group
Description:
Opioid and Benzodiazepine Tolerant-patients, defined as use of medications on most days for 1 or more months (\>30 days) prior to surgery
Treatment:
Behavioral: Opioid and Benzodiazepine Tolerant-patients

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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