Elective Spine Surgery Receiving Pre and/or Postoperative Pain Control With OpioidsNCT04787692

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

A study testing Opioid and Benzodiazepine Naive-patients and Opioid and Benzodiazepine Tolerant-patients in people with Elective Spine Surgery Receiving Pre and/or Postoperative Pain Control With Opioids, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 to 75 years
Conditions the study is for: Elective Spine Surgery Receiving Pre and/or Postoperative Pain Control With Opioids
What is being tested?: Opioid and Benzodiazepine Naive-patients and Opioid and Benzodiazepine Tolerant-patients
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteUnited States
Study dates: 7 Aug 2020to 1 Jan 2022
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

Conditions: Elective Spine Surgery Receiving Pre and/or Postoperative Pain Control With Opioids
Being tested: Opioid and Benzodiazepine Naive-patients, Opioid and Benzodiazepine Tolerant-patients
Keywords: Opioid taper, post-surgery, behavioral tele-health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Opioid and Benzodiazepine Naive-patientsBehavioural
Duration of treatment : 1 month Lucid Lane is a service that will be used by patients scheduled for elective orthopedic or neurosurgical spine surgery that will incorporate continuous MEASUREMENT \& MONITORING, PERSONALIZED TREATMENT PLANNING and REAL-TIME INTERVENTIONS (MPI) as the patient is tapering off of opioids and/or benzodiazepines. Patients will participate in the Lucid Lane program.Daily support will include 1 or more from the following: Therapist chat, and/or audio psychotherapy sessions, and/or group therapy sessions, Cognitive behavioral therapy(CBT), Mindfulness, and/or peer support. Patients will submit a weekly survey and the therapist will submit weekly reports to the physician.
Opioid and Benzodiazepine Tolerant-patientsBehavioural
Duration of treatment : 6 months Lucid Lane is a service that will be used by patients scheduled for elective orthopedic or neurosurgical spine surgery that will incorporate continuous MEASUREMENT \& MONITORING, PERSONALIZED TREATMENT PLANNING and REAL-TIME INTERVENTIONS (MPI) as the patient is tapering off of opioids and/or benzodiazepines. Patients will participate in the Lucid Lane program.Daily support will include 1 or more from the following: Therapist chat, and/or audio psychotherapy sessions, and/or group therapy sessions, CBT, Mindfulness, and/or peer support. Patients will submit a weekly survey and the therapist will submit weekly reports to the physician.

Study groups in NCT04787692
Study group	Role	What they receive
Opioid and Benzodiazepine Naive-patients	Experimental	Opioid and Benzodiazepine Naive-patients, defined as no medications 30 days prior to surgery Receives: Behavioral: Opioid and Benzodiazepine Naive-patients
Opioid and Benzodiazepine Tolerant-patients	Experimental	Opioid and Benzodiazepine Tolerant-patients, defined as use of medications on most days for 1 or more months (>30 days) prior to surgery Receives: Behavioral: Opioid and Benzodiazepine Tolerant-patients

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of patients that engage and participate in the process
Engagement and participation are defined as patient's commitment for 1 hour a week as scheduled.
Measured: 30 days post intervention
Number of patients that engage and participate in the process
Engagement and participation are defined as patient's commitment for 1 hour a week as scheduled.
Measured: 90 days post intervention
Number of patients that engage and participate in the process
Engagement and participation are defined as patient's commitment for 1 hour a week as scheduled.
Measured: 180 days post intervention

Secondary outcomes (15)

Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid
Measured: 30 days post intervention
Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid
Measured: 90 days post intervention
Percentage of patients in the tolerant group that successfully taper off of the benzodiazepine or opioid
Measured: 180 days post intervention
Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale
The Generalized Anxiety Disorder 7-item (GAD-7) scale has 7 questions each ranging in score from 0-3, with a higher score indicating a worse outcome.
Measured: 30 days post intervention
Emotional well-being as measured by the The Patient Health Questionnaire 9 (PHQ-9)
The Patient Health Questionnaire 9 (PHQ-9) consists of 10 questions with a total score ranging form 1 to 27, with a higher score indicating greater depression.
Measured: 30 days post intervention
Symptoms as measured by the Edmonton Symptom Assessment System (ESAS)
The Edmonton Symptom Assessment System consists of 10 questions, each question ranging from 0-10, with a higher score indicating a worse outcome. The ESAS rates the intensity of common symptoms, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath.
Measured: 30 days post intervention
Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale
The Generalized Anxiety Disorder 7-item (GAD-7) scale has 7 questions each ranging in score from 0-3, with a higher score indicating a worse outcome.
Measured: 90 days post intervention
Emotional well-being as measured by the Patient Health Questionnaire 9 (PHQ-9)
The Patient Health Questionnaire 9 (PHQ-9) consists of 10 questions with a total score ranging form 1 to 27, with a higher score indicating greater depression.
Measured: 90 days post intervention
Well-Being as measured by the Edmonton Symptom Assessment System (ESAS)
The Edmonton Symptom Assessment System consists of 10 questions, each question ranging from 0-10, with a higher score indicating a worse outcome. The ESAS rates the intensity of common symptoms, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath.
Measured: 90 days post intervention
Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale
The Generalized Anxiety Disorder 7-item (GAD-7) scale has 7 questions each ranging in score from 0-3, with a higher score indicating a worse outcome.
Measured: 180 days post intervention
Emotional well-being as measured by the Patient Health Questionnaire 9 (PHQ-9)
The Patient Health Questionnaire 9 (PHQ-9) consists of 10 questions with a total score ranging form 1 to 27, with a higher score indicating greater depression.
Measured: 180 days post intervention
Well-Being as measured by the Edmonton Symptom Assessment System (ESAS)
The Edmonton Symptom Assessment System consists of 10 questions, each question ranging from 0-10, with a higher score indicating a worse outcome. The ESAS rates the intensity of common symptoms, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath.
Measured: 180 days post intervention
Quality of life as measured by the Quality of life Score
The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life.
Measured: 30 days post intervention
Quality of life as measured by the Quality of life Score
The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life.
Measured: 90 days post intervention
Quality of life as measured by the Quality of life Score
The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life.
Measured: 180 days post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Aug 20201 Jan 2022

First posted9 Mar 2021
Study start7 Aug 2020
Primary completion1 Jan 2022
Study completion1 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Elective Spine Surgery Receiving Pre and/or Postoperative Pain Control With OpioidsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04787692
Sponsor's protocol ID: HSC-MS-20-0549
Status last verified: Feb 2022
First submitted: 3 Mar 2021
Last updated: 4 Feb 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hussain M, Norgeot B, Zaafran A, Stark J, Caridi J, Fenoy A, Pivalizza E. Virtual transitional pain service delivered via telehealth is effective in preventing new and persistent opioid use amongst post-surgical spine patients. medRxiv [Preprint]. 2023 Aug 20:2023.08.18.23294272. doi: 10.1101/2023.08.18.23294272.
PubMed 37645940