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.
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
- Are there results?
- None posted in the registry
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
About this study
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.
- 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 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.
- 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.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evan Pivalizza, The University of Texas Health Science Center, Houston
- Investigators
- Evan G Pivalizza, MD, Principal investigator, The University of Texas Health Science Center, Houston
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids and Benzodiazepines.
- ClinicalTrials.gov ID
- NCT04787692
- Acronym / sponsor ID
- HSC-MS-20-0549
- Keywords
- Opioid taper, post-surgery, behavioral tele-health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid and Benzodiazepine Naive-patients | Experimental | Behavioral: Opioid and Benzodiazepine Naive-patientsOpioid and Benzodiazepine Naive-patients, defined as no medications 30 days prior to surgery |
| Opioid and Benzodiazepine Tolerant-patients | Experimental | Behavioral: Opioid and Benzodiazepine Tolerant-patientsOpioid and Benzodiazepine Tolerant-patients, defined as use of medications on most days for 1 or more months (>30 days) prior to surgery |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid and Benzodiazepine Naive-patientsDuration 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. | Behavioural | Opioid and Benzodiazepine Naive-patients |
| Opioid and Benzodiazepine Tolerant-patientsDuration 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. | Behavioural | Opioid and Benzodiazepine Tolerant-patients |
Primary outcome
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.
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.
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.
15 secondary outcomes
Percentage of patients in the naive group that successfully taper off of the benzodiazepine or opioid
Time frame: 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
Percentage of patients in the tolerant group that successfully taper off of the benzodiazepine or opioid
Time frame: 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
Emotional well-being as measured by the The Patient Health Questionnaire 9 (PHQ-9)
Time frame: 30 days post intervention
Symptoms as measured by the Edmonton Symptom Assessment System (ESAS)
Time frame: 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
Emotional well-being as measured by the Patient Health Questionnaire 9 (PHQ-9)
Time frame: 90 days post intervention
Well-Being as measured by the Edmonton Symptom Assessment System (ESAS)
Time frame: 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
Emotional well-being as measured by the Patient Health Questionnaire 9 (PHQ-9)
Time frame: 180 days post intervention
Well-Being as measured by the Edmonton Symptom Assessment System (ESAS)
Time frame: 180 days post intervention
Quality of life as measured by the Quality of life Score
Time frame: 30 days post intervention
Quality of life as measured by the Quality of life Score
Time frame: 90 days post intervention
Quality of life as measured by the Quality of life Score
Time frame: 180 days post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Derived from this study: PubMed 37645940Hussain 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan G Pivalizza, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that engage and participate in the process (time frame: 30 days post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04787692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.