Opioid-use DisorderPhase 4NCT04981678
The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder
A Phase 4 study testing Buprenorphine in people with Opioid-use Disorder, run by MaineHealth at 1 site in United States.
Trial summary
There is limited guidance on the optimal management of buprenorphine perioperatively and both buprenorphine discontinuation and continuation are acceptable standards of care. Buprenorphine continuation at low analgesic dosing is also accepted, however is not provided as a potential treatment strategy by the Substance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Buprenorphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 16 Oct 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- age 18 and older
- American Society of Anesthesia health class I-III
- Currently taking buprenorphine formulation equivalent to 12mg or greater for at least 30 days for treatment of Opioid Use Disorder
- Scheduled for surgery at Maine Medical Center for a procedure with a greater than 4/10 pain intensity is expected on post-op day one.
Who cannot join
- unable to consent to the study
- currently pregnant
- current major medical illness that could limit the ability to utilize medications within our protocol driven multimodal analgesic plan (e.g. cancer, severe end-stage organ disease, or dementia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized Trial of the Effect of Buprenorphine Continuation Versus Dose Reduction on Pain Control and Post-Operative Opioid Use
There is limited guidance on the optimal management of buprenorphine perioperatively and both buprenorphine discontinuation and continuation are acceptable standards of care. Buprenorphine continuation at low analgesic dosing is also accepted, however is not provided as a potential treatment strategy by the Substance Abuse and Mental Health Services Administration (SAMHSA). There is the risk of inadequate pain control necessitating opioid escalation when buprenorphine is continued. Preliminary clinical observations support buprenorphine continuation at low analgesic doses (8mg) as it adequately facilitates postoperative pain management without interrupting opioid use disorder (OUD) treatment, however to date, no prospective trial has investigated this treatment strategy in comparison to full dose buprenorphine continuation. Since optimal perioperative dosing strategies remain unknown, the purpose of this study is to investigate if buprenorphine continuation at analgesic dosing is superior to full dose buprenorphine continuation in individuals presenting for elective surgery.
Read the detailed description
The purpose of this study is to investigate whether buprenorphine continuation at analgesic dosing is superior to full dose buprenorphine continuation in individuals presenting for elective surgery. Adults scheduled for elective surgery who are taking ≥12mg buprenorphine for OUD treatment will be eligible for this study. Enrolled participants will be randomized to receive either a reduced analgesic dose of buprenorphine (8mg) or to continue buprenorphine on the day of surgery without dose reduction. The primary outcome of interest is postoperative pain scores. The secondary outcomes of interest are opioid consumption, opioid dispensing up to 30 days following the surgical procedure and OUD related symptoms, including opioid withdrawal, cravings and relapse. The investigators hypothesis is that there will be a clinically significant increase in pain scores when buprenorphine is continued in full compared to when it is continued at a lower analgesic dose. Clinical significance will be defined as a difference in composite pain scores of greater than 20% between groups. The investigators also hypothesize that opioid consumption and opioid dispensing will be greater with full dose buprenorphine continuation compared to low-dose continuation.
- Conditions
- Opioid-use Disorder
- Being tested
- Buprenorphine
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
Patients randomized to this group will reduce their buprenorphine dose prior to surgery.
BuprenorphineDrug
Patients randomized to this group will continue their buprenorphine at the full prescribed dose.
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine Dose Reduction | Other | Patients instructed to reduce buprenorphine to 8mg prior to surgery Receives: Drug: Buprenorphine |
| Buprenorphine Full Dose Continuation | Other | Patients instructed to continue taking the full prescribed dose of buprenorphine. Receives: Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain Scores: 24 Hours After Surgery
Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain)
Measured: 24 hours after surgery
Post-operative Pain Scores: 48 Hours After Surgery
Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain)
Measured: 48 hours after surgery
Post-operative Pain Scores: 72 Hours After Surgery
Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain)
Measured: 72 hours after surgery
Secondary outcomes (8)
Opioid Consumption
All opioids consumed through 72 hours after surgery combined into mean morphine equivalents
Measured: 3 days post-op
Opioid Dispensing
Prescriptions filled for the patient in the Prescription Awareness Tool
Measured: 30 days following surgery
Opioid Withdrawal
Withdrawal symptoms as measured by the Clinical Opioid Withdrawal Scale (COWS, scores can range from 0-48 [5-12 mild; 13-24, moderate; 25-36, moderately severe; >36, severe withdrawal)
Measured: 1-3 hours prior to surgery
Opioid Cravings
Measured by the Opioid Craving Scale (OCS); scale ranges from 0-30 with higher scores indicating higher levels of cravings
Measured: 1-3 hours prior to surgery
Opioid Cravings
Measured by the Opioid Craving Scale (OCS); scale ranges from 0-30 with higher scores indicating higher levels of cravings
Measured: 30 days following surgery
Opioid Misuse
Measured by the Current Opioid Misuse Measure ((COMM); scores can range from 0-68, scores of 9 or lower indicates a low risk of opioid misuse or abuse, scores higher than 9 indicate a high risk)
Measured: 1-3 hours prior to surgery
Opioid Misuse
Measured by the Current Opioid Misuse Measure ((COMM); scores can range from 0-68, scores of 9 or lower indicates a low risk of opioid misuse or abuse, scores higher than 9 indicate a high risk)
Measured: 30 days following surgery
Opioid Relapse
Patient reported use of non-prescribed opioids
Measured: 30 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Jan 2022
- Primary completion15 Sep 2023
- Study completion16 Oct 2023
Why it stopped: This study was halted prior to accumulating the full number of participants due to difficulty in recruiting study subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid-use DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Aurora Quaye, MD, Principal investigator, Maine Medical Center; Spectrum Healthcare Partners
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981678
- Sponsor's protocol ID
- 1688818-1
- Other IDs
- U54GM115516-06
- Status last verified
- Nov 2024
- First submitted
- 8 Jul 2021
- Last updated
- 13 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial of the Effect of Buprenorphine Continuation Versus Dose Reduction on Pain Control and Post-Operative Opioid Use
- ClinicalTrials.gov ID
- NCT04981678
- Acronym / sponsor ID
- 1688818-1
- Conditions
- Opioid-use Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was halted prior to accumulating the full number of participants due to difficulty in recruiting study subjects.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Posted 13 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is limited guidance on the optimal management of buprenorphine perioperatively and both buprenorphine discontinuation and continuation are acceptable standards of care. Buprenorphine continuation at low analgesic dosing is also accepted, however is not provided as a potential treatment strategy by the Substance Abuse and Mental Health Services Administration (SAMHSA). There is the risk of inadequate pain control necessitating opioid escalation when buprenorphine is continued. Preliminary clinical observations support buprenorphine continuation at low analgesic doses (8mg) as it adequately facilitates postoperative pain management without interrupting opioid use disorder (OUD) treatment, however to date, no prospective trial has investigated this treatment strategy in comparison to full dose buprenorphine continuation. Since optimal perioperative dosing strategies remain unknown, the purpose of this study is to investigate if buprenorphine continuation at analgesic dosing is superior to full dose buprenorphine continuation in individuals presenting for elective surgery.
Detailed description
The purpose of this study is to investigate whether buprenorphine continuation at analgesic dosing is superior to full dose buprenorphine continuation in individuals presenting for elective surgery. Adults scheduled for elective surgery who are taking ≥12mg buprenorphine for OUD treatment will be eligible for this study. Enrolled participants will be randomized to receive either a reduced analgesic dose of buprenorphine (8mg) or to continue buprenorphine on the day of surgery without dose reduction. The primary outcome of interest is postoperative pain scores. The secondary outcomes of interest are opioid consumption, opioid dispensing up to 30 days following the surgical procedure and OUD related symptoms, including opioid withdrawal, cravings and relapse. The investigators hypothesis is that there will be a clinically significant increase in pain scores when buprenorphine is continued in full compared to when it is continued at a lower analgesic dose. Clinical significance will be defined as a difference in composite pain scores of greater than 20% between groups. The investigators also hypothesize that opioid consumption and opioid dispensing will be greater with full dose buprenorphine continuation compared to low-dose continuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine Dose Reduction | Other | Drug: BuprenorphinePatients instructed to reduce buprenorphine to 8mg prior to surgery |
| Buprenorphine Full Dose Continuation | Other | Drug: BuprenorphinePatients instructed to continue taking the full prescribed dose of buprenorphine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 and older
- American Society of Anesthesia health class I-III
- Currently taking buprenorphine formulation equivalent to 12mg or greater for at least 30 days for treatment of Opioid Use Disorder
- Scheduled for surgery at Maine Medical Center for a procedure with a greater than 4/10 pain intensity is expected on post-op day one.
Key exclusion criteria (3 listed)
- unable to consent to the study
- currently pregnant
- current major medical illness that could limit the ability to utilize medications within our protocol driven multimodal analgesic plan (e.g. cancer, severe end-stage organ disease, or dementia)
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 |
|---|---|---|
| BuprenorphinePatients randomized to this group will reduce their buprenorphine dose prior to surgery. | Drug | Buprenorphine Dose Reduction |
| BuprenorphinePatients randomized to this group will continue their buprenorphine at the full prescribed dose. | Drug | Buprenorphine Full Dose Continuation |
Primary outcome
Post-operative Pain Scores: 24 Hours After Surgery
Time frame: 24 hours after surgery
Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain)
Post-operative Pain Scores: 48 Hours After Surgery
Time frame: 48 hours after surgery
Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain)
Post-operative Pain Scores: 72 Hours After Surgery
Time frame: 72 hours after surgery
Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain)
8 secondary outcomes
Opioid Consumption
Time frame: 3 days post-op
Opioid Dispensing
Time frame: 30 days following surgery
Opioid Withdrawal
Time frame: 1-3 hours prior to surgery
Opioid Cravings
Time frame: 1-3 hours prior to surgery
Opioid Cravings
Time frame: 30 days following surgery
Opioid Misuse
Time frame: 1-3 hours prior to surgery
Opioid Misuse
Time frame: 30 days following surgery
Opioid Relapse
Time frame: 30 days following surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Aurora Quaye, MD principal investigator
Maine Medical Center; Spectrum Healthcare Partners
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buprenorphine in people with Opioid-use Disorder, run by MaineHealth 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 3 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: stopped early, as of the sponsor's last update on 13 Dec 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-operative Pain Scores: 24 Hours After Surgery (time frame: 24 hours after surgery). 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?
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 13 Dec 2024.