Clinical trial NCT04787692: Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids and Benzodiazepines.
Official title: Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids and Benzodiazepines.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elective Spine Surgery Receiving Pre and/or Postoperative Pain Control With Opioids
Keywords: Opioid taper
post-surgery
behavioral tele-health
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients that engage and participate in the process
timeFrame: 30 days post intervention
measure: Number of patients that engage and participate in the process
timeFrame: 90 days post intervention
measure: Number of patients that engage and participate in the process
timeFrame: 180 days post intervention
Secondary outcomes:
measure: Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid
timeFrame: 30 days post intervention
measure: Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid
timeFrame: 90 days post intervention
measure: Percentage of patients in the tolerant group that successfully taper off of the benzodiazepine or opioid
timeFrame: 180 days post intervention
measure: Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale
timeFrame: 30 days post intervention
measure: Emotional well-being as measured by the The Patient Health Questionnaire 9 (PHQ-9)
timeFrame: 30 days post intervention
measure: Symptoms as measured by the Edmonton Symptom Assessment System (ESAS)
timeFrame: 30 days post intervention
measure: Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale
timeFrame: 90 days post intervention
measure: Emotional well-being as measured by the Patient Health Questionnaire 9 (PHQ-9)
timeFrame: 90 days post intervention
measure: Well-Being as measured by the Edmonton Symptom Assessment System (ESAS)
timeFrame: 90 days post intervention
measure: Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale
timeFrame: 180 days post intervention
measure: Emotional well-being as measured by the Patient Health Questionnaire 9 (PHQ-9)
timeFrame: 180 days post intervention
measure: Well-Being as measured by the Edmonton Symptom Assessment System (ESAS)
timeFrame: 180 days post intervention
measure: Quality of life as measured by the Quality of life Score
timeFrame: 30 days post intervention
measure: Quality of life as measured by the Quality of life Score
timeFrame: 90 days post intervention
measure: Quality of life as measured by the Quality of life Score
timeFrame: 180 days post intervention
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Evan G Pivalizza, MD
role: PRINCIPAL_INVESTIGATOR
References: