Opioid Consumption, PostoperativeNCT07221786
Preoperative Opioid Tapering Before Spine Surgery
A study testing Opioid tapering with CBT and education and Opioid tapering with education alone in people with Opioid Consumption, Postoperative and Pain After Surgery, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This is a pilot study in which patients taking opioids chronically who are scheduled for spine surgery at least 4 weeks in advance will be randomly assigned to one of two groups: opioid tapering with education alone or opioid tapering with education plus cognitive behavioral therapy (CBT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Consumption, Postoperative, Pain After Surgery, Opioid Dependency
- What is being tested?
- Opioid tapering with CBT and education and Opioid tapering with education alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years old
- scheduled for major spine surgery (i.e. at least 1 level of fusion) with hospital admission of at least one night
- scheduled for spine surgery at least 4 weeks ahead of time
- takes between 40 and 200 oral morphine equivalents daily
Who cannot join
- inability to use a computer or tablet for telemedicine encounters
- non-English-speaking
- inability to complete assessments
- positive screen on the Columbia Suicide Screening Assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jeffrey Mojica, DO contact
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University Hospital
Philadephia, Pennsylvania, 19107
Eric Schwenk, MD, 919-360-0762, eric.schwenk@jefferson.edu
Jeffrey Mojica, DO, 856-979-1643, jeffrey.mojica@jefferson.edu
About this study
Official title: A Pilot Study of the Feasibility of Preoperative Opioid Tapering Before Spine Surgery Using Cognitive Behavioral Therapy and Measuring Postoperative Outcomes
This is a pilot study in which patients taking opioids chronically who are scheduled for spine surgery at least 4 weeks in advance will be randomly assigned to one of two groups: opioid tapering with education alone or opioid tapering with education plus cognitive behavioral therapy (CBT). The primary objective is to determine the proportion of each group that is successful in achieving their opioid tapering goals by the time of surgery.
Read the detailed description
The perioperative period represents a particularly problematic time for opioid-dependent patients. Perioperative pain is often difficult to control, with opioid tolerance, opioid-induced hyperalgesia, and withdrawal making management a challenge. In addition to these short-term challenges, opioid-dependent patients experience poorer outcomes after surgery, including both early and late complications, emergency room visits, infections, and reoperations. Spine surgery in opioid-tolerant patients increases the risk for prolonged postoperative opioid use. This risk is in addition to the risk of prolonged opioid use that surgery itself introduces. The high prevalence of opioid use in spine patients makes spine surgery an ideal surgical model in which to study opioid tapering.
This is a randomized, controlled pilot study of 45 opioid-dependent patients undergoing spine surgery. Patients will be assigned in parallel to one of the following: 1. opioid tapering with education alone or 2. opioid tapering with education plus cognitive behavioral therapy (CBT). While all patients will meet with a pain physician to design a personalized tapering program, the CBT group will receive two CBT sessions prior to surgery. Pain, depression, anxiety, and opioid withdrawal will be assessed throughout the month prior to surgery and managed appropriately. Opioid use at the time of surgery will be assessed along with pain and depression and anxiety. Hospital outcomes, including pain, opioid use, quality of recovery, and postoperative complications, will be measured. Patients will be followed upon discharge by a chronic pain physician and patients assigned to CBT will receive one additional session after surgery. All patients will also be assessed via telephone call or Zoom at 30, 90, 180, and 365 days for pain, function, and opioid use.
- Being tested
- Opioid tapering with CBT and education, Opioid tapering with education alone
- Keywords
- spine surgery, pain management, opioids, opioid use, depression, anxiety, opioid dependence, opioid tapering, cognitive behavioral therapy
- Medical subject headings
- Agnosia, Depression, Anxiety Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid tapering with CBT and educationOther
Patients in the opioid tapering plus CBT group will set up an initial meeting with the pain physician within a few days of enrollment to set the tapering schedule. They will also have two CBT appointments set up to complete via telemedicine during the time between enrollment and surgery.
Opioid tapering with education aloneOther
Patients in this group will be instructed to continue their opioids at the same doses and frequencies they were taking up through the day of surgery. They will set up an initial meeting within a few days of enrollment with the chronic pain physician to determine the tapering schedule which will occur over 4 weeks or more leading into surgery. The patient and pain physician will collectively agree on a tapering schedule.
| Study group | Role | What they receive |
|---|---|---|
| Opioid tapering with Cognitive Behavioral Therapy (CBT) and education | Active comparator | The CBT group will receive two preoperative sessions and at least one postoperative session conducted via telemedicine and performed by a pain psychologist. CBT sessions will focus on training in non-pharmacologic pain-coping skills, reducing the frequency and impact of negative pain-related cognitions and emotions, and on setting realistic behavioral goals.
Patients will participate in the creation of an opioid tapering plan and will receive opioid education as well as education on how to taper opioids, the possibility of increased pain, the possibility of withdrawal symptoms, and the risks related to opioids, as well as the data on worsened perioperative outcomes in patients taking opioids. Receives: Other: Opioid tapering with CBT and education |
| Opioid tapering with education alone | Active comparator | In this group patients will participate in the creation of an opioid tapering plan and will receive opioid education as well as education on how to taper opioids, the possibility of increased pain, the possibility of withdrawal symptoms, and the risks related to opioids, as well as the data on worsened perioperative outcomes in patients taking opioids. Receives: Other: Opioid tapering with education alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion that achieved opioid tapering goal
Achievement of the opioid tapering goal for each patient will be assessed on day of surgery and will be based on average daily OMEs taken during the three days before surgery. The opioid tapering goal will be made on the initial visit with the study pain physician and will be specific to each patient.
Measured: Perioperative prior to surgery (postoperative day 0)
Secondary outcomes (16)
Brief Pain Inventory
Brief Pain Inventory is a validated pain assessment tool that measures pain severity and its effects on daily function.
Measured: Baseline, weeks 1-4 before surgery, day of surgery (postoperative day 0), postoperative days 1-3, and postoperative days 30, 90, 180 and 365.
Clinical Opiate Withdrawal Scale
Standardized assessment of opioid withdrawal
Measured: Baseline, once weekly on weeks 1-4 prior to surgery, day of surgery (postoperative day 0), postoperative day 1, and postoperative days 30, 90, 180, and 365.
Patient Health Questionnaire-9
Depression screening
Measured: Baseline, weeks 1-4 prior to surgery, and postoperative days 30, 90, 180, and 365
Generalized Anxiety Disorder-2
Standardized generalized anxiety screening
Measured: Baseline
Columbia Suicide Screening Assessment
This is a suicide risk screening tool
Measured: Screening period
Daily opioid use in hospital
This will be the average daily opioid use in the hospital
Measured: Postoperative days 0-7
Hospital length of stay
Duration of hospital stay in days
Measured: Postoperative days 0-7
Quality of recovery-15
This is a validated 15-question assessment of quality of recovery
Measured: Preoperative baseline, postoperative days 1-2
Hospital Anxiety and Depression Scale
Anxiety and depression assessment for the hospitalization
Measured: Postoperative days 0-3
Opioid use in daily OMEs
Patient-reported daily opioid use on average in mg
Measured: Day of surgery (postoperative day 0), postoperative days 30, 90, 180 and 365
Daily opioid use in OMEs from prescription drug monitoring program
This is the prescribed daily opioids confirmed from the PDMP.
Measured: Day of surgery (postoperative day 0), postoperative days 30, 90, 180, and 365
Nausea and vomiting
Nausea and vomiting measured on the following scale: 0=AE not experienced; 1=AE experienced but no treatment needed; 2=AE experienced and treatment was effective; 3=AE experienced and treatment was ineffective
Measured: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365
Constipation
Constipation: 0=AE not experienced; 1=AE experienced but no treatment needed; 2=AE experienced and treatment was effective; 3=AE experienced and treatment was ineffective
Measured: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365
Pruritus
Puritus: 0=AE not experienced; 1=AE experienced but no treatment needed; 2=AE experienced and treatment was effective; 3=AE experienced and treatment was ineffective
Measured: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365
Patient satisfaction with pain control
0-10 scale with 0 being worst possible pain control and 10 being best possible pain control
Measured: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365
SF-12
This is a brief assessment of physical and mental function
Measured: Baseline, day of surgery (postoperative day 0), and postoperative days 30, 90, 180, and 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start1 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Opioid Consumption, PostoperativeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Schwenk, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221786
- Sponsor's protocol ID
- IRB Control #22D.843_JT#25484
- Status last verified
- Jan 2026
- First submitted
- 23 Oct 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Darnall BD, Roy A, Chen AL, Ziadni MS, Keane RT, You DS, Slater K, Poupore-King H, Mackey I, Kao MC, Cook KF, Lorig K, Zhang D, Hong J, Tian L, Mackey SC. Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2113401. doi: 10.1001/jamanetworkopen.2021.13401.
PubMed 34398206Hassamal S, Haglund M, Wittnebel K, Danovitch I. A preoperative interdisciplinary biopsychosocial opioid reduction program in patients on chronic opioid analgesia prior to spine surgery: A preliminary report and case series. Scand J Pain. 2016 Oct;13:27-31. doi: 10.1016/j.sjpain.2016.06.007. Epub 2016 Jul 4.
PubMed 28850531Bicket MC, Gunaseelan V, Lagisetty P, Fernandez AC, Bohnert A, Assenmacher E, Sequeira M, Englesbe MJ, Brummett CM, Waljee JF. Association of opioid exposure before surgery with opioid consumption after surgery. Reg Anesth Pain Med. 2022 Jun;47(6):346-352. doi: 10.1136/rapm-2021-103388. Epub 2022 Mar 3.
PubMed 35241626Kalakoti P, Volkmar AJ, Bedard NA, Eisenberg JM, Hendrickson NR, Pugely AJ. Preoperative Chronic Opioid Therapy Negatively Impacts Long-term Outcomes Following Cervical Fusion Surgery. Spine (Phila Pa 1976). 2019 Sep;44(18):1279-1286. doi: 10.1097/BRS.0000000000003064.
PubMed 30973507Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
PubMed 28403427Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298.
PubMed 27400458Reyes AA, Canseco JA, Mangan JJ, Divi SN, Goyal DKC, Bowles DR, Patel PD, Salmons HI, Morgenstern M, Anderson DG, Rihn JA, Kurd MF, Hilibrand AS, Kepler CK, Vaccaro AR, Schroeder GD. Risk Factors for Prolonged Opioid Use and Effects of Opioid Tolerance on Clinical Outcomes After Anterior Cervical Discectomy and Fusion Surgery. Spine (Phila Pa 1976). 2020 Jul 15;45(14):968-975. doi: 10.1097/BRS.0000000000003511.
PubMed 32604353Colvin LA, Bull F, Hales TG. Perioperative opioid analgesia-when is enough too much? A review of opioid-induced tolerance and hyperalgesia. Lancet. 2019 Apr 13;393(10180):1558-1568. doi: 10.1016/S0140-6736(19)30430-1.
PubMed 30983591
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Feasibility of Preoperative Opioid Tapering Before Spine Surgery Using Cognitive Behavioral Therapy and Measuring Postoperative Outcomes
- ClinicalTrials.gov ID
- NCT07221786
- Acronym / sponsor ID
- IRB Control #22D.843_JT#25484
- Keywords
- spine surgery, pain management, opioids, opioid use, depression, anxiety, opioid dependence, opioid tapering
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Oct 2025 (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.
This is a pilot study in which patients taking opioids chronically who are scheduled for spine surgery at least 4 weeks in advance will be randomly assigned to one of two groups: opioid tapering with education alone or opioid tapering with education plus cognitive behavioral therapy (CBT). The primary objective is to determine the proportion of each group that is successful in achieving their opioid tapering goals by the time of surgery.
Detailed description
The perioperative period represents a particularly problematic time for opioid-dependent patients. Perioperative pain is often difficult to control, with opioid tolerance, opioid-induced hyperalgesia, and withdrawal making management a challenge. In addition to these short-term challenges, opioid-dependent patients experience poorer outcomes after surgery, including both early and late complications, emergency room visits, infections, and reoperations. Spine surgery in opioid-tolerant patients increases the risk for prolonged postoperative opioid use. This risk is in addition to the risk of prolonged opioid use that surgery itself introduces. The high prevalence of opioid use in spine patients makes spine surgery an ideal surgical model in which to study opioid tapering.
This is a randomized, controlled pilot study of 45 opioid-dependent patients undergoing spine surgery. Patients will be assigned in parallel to one of the following: 1. opioid tapering with education alone or 2. opioid tapering with education plus cognitive behavioral therapy (CBT). While all patients will meet with a pain physician to design a personalized tapering program, the CBT group will receive two CBT sessions prior to surgery. Pain, depression, anxiety, and opioid withdrawal will be assessed throughout the month prior to surgery and managed appropriately. Opioid use at the time of surgery will be assessed along with pain and depression and anxiety. Hospital outcomes, including pain, opioid use, quality of recovery, and postoperative complications, will be measured. Patients will be followed upon discharge by a chronic pain physician and patients assigned to CBT will receive one additional session after surgery. All patients will also be assessed via telephone call or Zoom at 30, 90, 180, and 365 days for pain, function, and opioid use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid tapering with Cognitive Behavioral Therapy (CBT) and education | Active comparator | Other: Opioid tapering with CBT and educationThe CBT group will receive two preoperative sessions and at least one postoperative session conducted via telemedicine and performed by a pain psychologist. CBT sessions will focus on training in non-pharmacologic pain-coping skills, reducing the frequency and impact of negative pain-related cognitions and emotions, and on setting realistic behavioral goals. Patients will participate in the creation of an opioid tapering plan and will receive opioid education as well as education on how to taper opioids, the possibility of increased pain, the possibility of withdrawal symptoms, and the risks related to opioids, as well as the data on worsened perioperative outcomes in patients taking opioids. |
| Opioid tapering with education alone | Active comparator | Other: Opioid tapering with education aloneIn this group patients will participate in the creation of an opioid tapering plan and will receive opioid education as well as education on how to taper opioids, the possibility of increased pain, the possibility of withdrawal symptoms, and the risks related to opioids, as well as the data on worsened perioperative outcomes in patients taking opioids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 18 years old
- scheduled for major spine surgery (i.e. at least 1 level of fusion) with hospital admission of at least one night
- scheduled for spine surgery at least 4 weeks ahead of time
- takes between 40 and 200 oral morphine equivalents daily
Key exclusion criteria (4 listed)
- inability to use a computer or tablet for telemedicine encounters
- non-English-speaking
- inability to complete assessments
- positive screen on the Columbia Suicide Screening Assessment
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 tapering with CBT and educationPatients in the opioid tapering plus CBT group will set up an initial meeting with the pain physician within a few days of enrollment to set the tapering schedule. They will also have two CBT appointments set up to complete via telemedicine during the time between enrollment and surgery. | Other | Opioid tapering with Cognitive Behavioral Therapy (CBT) and education |
| Opioid tapering with education alonePatients in this group will be instructed to continue their opioids at the same doses and frequencies they were taking up through the day of surgery. They will set up an initial meeting within a few days of enrollment with the chronic pain physician to determine the tapering schedule which will occur over 4 weeks or more leading into surgery. The patient and pain physician will collectively agree on a tapering schedule. | Other | Opioid tapering with education alone |
Primary outcome
proportion that achieved opioid tapering goal
Time frame: Perioperative prior to surgery (postoperative day 0)
Achievement of the opioid tapering goal for each patient will be assessed on day of surgery and will be based on average daily OMEs taken during the three days before surgery. The opioid tapering goal will be made on the initial visit with the study pain physician and will be specific to each patient.
16 secondary outcomes
Brief Pain Inventory
Time frame: Baseline, weeks 1-4 before surgery, day of surgery (postoperative day 0), postoperative days 1-3, and postoperative days 30, 90, 180 and 365.
Clinical Opiate Withdrawal Scale
Time frame: Baseline, once weekly on weeks 1-4 prior to surgery, day of surgery (postoperative day 0), postoperative day 1, and postoperative days 30, 90, 180, and 365.
Patient Health Questionnaire-9
Time frame: Baseline, weeks 1-4 prior to surgery, and postoperative days 30, 90, 180, and 365
Generalized Anxiety Disorder-2
Time frame: Baseline
Columbia Suicide Screening Assessment
Time frame: Screening period
Daily opioid use in hospital
Time frame: Postoperative days 0-7
Hospital length of stay
Time frame: Postoperative days 0-7
Quality of recovery-15
Time frame: Preoperative baseline, postoperative days 1-2
Hospital Anxiety and Depression Scale
Time frame: Postoperative days 0-3
Opioid use in daily OMEs
Time frame: Day of surgery (postoperative day 0), postoperative days 30, 90, 180 and 365
Daily opioid use in OMEs from prescription drug monitoring program
Time frame: Day of surgery (postoperative day 0), postoperative days 30, 90, 180, and 365
Nausea and vomiting
Time frame: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365
Constipation
Time frame: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365
Pruritus
Time frame: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365
Patient satisfaction with pain control
Time frame: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365
SF-12
Time frame: Baseline, day of surgery (postoperative day 0), and postoperative days 30, 90, 180, and 365
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Background: PubMed 34398206Darnall BD, Roy A, Chen AL, Ziadni MS, Keane RT, You DS, Slater K, Poupore-King H, Mackey I, Kao MC, Cook KF, Lorig K, Zhang D, Hong J, Tian L, Mackey SC. Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2113401. doi: 10.1001/jamanetworkopen.2021.13401.
- Background: PubMed 28850531Hassamal S, Haglund M, Wittnebel K, Danovitch I. A preoperative interdisciplinary biopsychosocial opioid reduction program in patients on chronic opioid analgesia prior to spine surgery: A preliminary report and case series. Scand J Pain. 2016 Oct;13:27-31. doi: 10.1016/j.sjpain.2016.06.007. Epub 2016 Jul 4.
- Background: PubMed 35241626Bicket MC, Gunaseelan V, Lagisetty P, Fernandez AC, Bohnert A, Assenmacher E, Sequeira M, Englesbe MJ, Brummett CM, Waljee JF. Association of opioid exposure before surgery with opioid consumption after surgery. Reg Anesth Pain Med. 2022 Jun;47(6):346-352. doi: 10.1136/rapm-2021-103388. Epub 2022 Mar 3.
- Background: PubMed 30973507Kalakoti P, Volkmar AJ, Bedard NA, Eisenberg JM, Hendrickson NR, Pugely AJ. Preoperative Chronic Opioid Therapy Negatively Impacts Long-term Outcomes Following Cervical Fusion Surgery. Spine (Phila Pa 1976). 2019 Sep;44(18):1279-1286. doi: 10.1097/BRS.0000000000003064.
- Background: PubMed 28403427Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
- Background: PubMed 27400458Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298.
- Background: PubMed 32604353Reyes AA, Canseco JA, Mangan JJ, Divi SN, Goyal DKC, Bowles DR, Patel PD, Salmons HI, Morgenstern M, Anderson DG, Rihn JA, Kurd MF, Hilibrand AS, Kepler CK, Vaccaro AR, Schroeder GD. Risk Factors for Prolonged Opioid Use and Effects of Opioid Tolerance on Clinical Outcomes After Anterior Cervical Discectomy and Fusion Surgery. Spine (Phila Pa 1976). 2020 Jul 15;45(14):968-975. doi: 10.1097/BRS.0000000000003511.
- Background: PubMed 30983591Colvin LA, Bull F, Hales TG. Perioperative opioid analgesia-when is enough too much? A review of opioid-induced tolerance and hyperalgesia. Lancet. 2019 Apr 13;393(10180):1558-1568. doi: 10.1016/S0140-6736(19)30430-1.
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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.
Jeffrey Mojica, DO contact
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 tapering with CBT and education and Opioid tapering with education alone in people with Opioid Consumption, Postoperative and Pain After Surgery, run by Thomas Jefferson University 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Schwenk, MD (267-239-3319, eric.schwenk@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion that achieved opioid tapering goal (time frame: Perioperative prior to surgery (postoperative day 0)). 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 NCT07221786, which also lists 8 linked publications.
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 24 Mar 2026.