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

February 3, 2022 updated by: Evan Pivalizza, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Opioid and Benzodiazepine Naive-patients
Opioid and Benzodiazepine Naive-patients, defined as no medications 30 days prior to surgery
Behavioral: Opioid and Benzodiazepine Naive-patients
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.
EXPERIMENTAL: Opioid and Benzodiazepine Tolerant-patients
Opioid and Benzodiazepine Tolerant-patients, defined as use of medications on most days for 1 or more months (>30 days) prior to surgery
Behavioral: Opioid and Benzodiazepine Tolerant-patients
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients that engage and participate in the process
Time Frame: 30 days post intervention
Engagement and participation are defined as patient's commitment for 1 hour a week as scheduled.
30 days post intervention
Number of patients that engage and participate in the process
Time Frame: 90 days post intervention
Engagement and participation are defined as patient's commitment for 1 hour a week as scheduled.
90 days post intervention
Number of patients that engage and participate in the process
Time Frame: 180 days post intervention
Engagement and participation are defined as patient's commitment for 1 hour a week as scheduled.
180 days post intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid
Time Frame: 30 days post intervention
30 days post intervention
Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid
Time Frame: 90 days post intervention
90 days post intervention
Percentage of patients in the tolerant group that successfully taper off of the benzodiazepine or opioid
Time Frame: 180 days post intervention
180 days post intervention
Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale
Time Frame: 30 days post intervention
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.
30 days post intervention
Emotional well-being as measured by the The Patient Health Questionnaire 9 (PHQ-9)
Time Frame: 30 days post intervention
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.
30 days post intervention
Symptoms as measured by the Edmonton Symptom Assessment System (ESAS)
Time Frame: 30 days post intervention
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.
30 days post intervention
Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale
Time Frame: 90 days post intervention
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.
90 days post intervention
Emotional well-being as measured by the Patient Health Questionnaire 9 (PHQ-9)
Time Frame: 90 days post intervention
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.
90 days post intervention
Well-Being as measured by the Edmonton Symptom Assessment System (ESAS)
Time Frame: 90 days post intervention
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.
90 days post intervention
Emotional well-being as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale
Time Frame: 180 days post intervention
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.
180 days post intervention
Emotional well-being as measured by the Patient Health Questionnaire 9 (PHQ-9)
Time Frame: 180 days post intervention
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.
180 days post intervention
Well-Being as measured by the Edmonton Symptom Assessment System (ESAS)
Time Frame: 180 days post intervention
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.
180 days post intervention
Quality of life as measured by the Quality of life Score
Time Frame: 30 days post intervention
The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life.
30 days post intervention
Quality of life as measured by the Quality of life Score
Time Frame: 90 days post intervention
The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life.
90 days post intervention
Quality of life as measured by the Quality of life Score
Time Frame: 180 days post intervention
The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life.
180 days post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Evan G Pivalizza, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-20-0549

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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