Opioid Tapering for Chronic Pain

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Opioids

Must not be taking: Methadone, Buprenorphine, Benzodiazepines, others

Disqualifiers: Active cancer, Pregnancy, Suicidal intent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if people with chronic pain can safely reduce their opioid medications without worsening their pain or quality of life. Participants will either maintain their current opioid dose or gradually decrease it over time through slow tapering of chronic opioid therapy. It suits those who have been on a stable dose of specific opioid pills daily for at least six months and have no immediate plans to stop. As an unphased trial, this study offers participants the chance to contribute to important research on opioid reduction strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it focuses on gradually reducing opioid medications. You should discuss your specific situation with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that slowly reducing opioid use is generally safe and more comfortable for patients. Studies indicate that gradually cutting back the dose helps lessen discomfort and withdrawal symptoms. The CDC suggests reducing the dose by about 10% each week, and it can be even slower for long-term opioid users. This method is well-tolerated and aims to make the process as smooth as possible for everyone involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the slow tapering of chronic opioid therapy for chronic pain because it offers an alternative to the standard practice of maintaining stable opioid doses. Unlike keeping patients on a steady dose, this method gradually reduces opioid use, potentially minimizing dependency and side effects. By carefully tapering doses every four weeks, it aims to manage pain effectively while reducing the risk of long-term opioid dependency, which is a significant concern with traditional opioid therapies. This approach could pave the way for safer, more sustainable pain management solutions.

What evidence suggests that slow tapering of chronic opioid therapy could be effective for chronic pain?

Research has shown that gradually reducing opioid doses can help people on long-term opioid therapy without worsening their pain. In this trial, some participants will undergo a slow tapering of their chronic opioid therapy, with doses reduced every 4 weeks. One study found that tapering, or slowly lowering the dose, was quite beneficial. Another study showed that tapering reduced the risk of overdose for people with opioid use disorder, which is a positive outcome. Experts recommend decreasing the dose by 5–20% every 4 weeks to minimize withdrawal symptoms. Overall, these findings suggest that a slow tapering approach can be effective and safe for managing chronic pain. ^{1 3 6 7 8}

Who Is on the Research Team?

Terrence Witt, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients under chronic opioid therapy for pain, prescribed by MCHS NW WI, with a daily dose ≤90 MME using specific opioids in tablet/capsule form. Participants must be able to consent and commit to the study's requirements. Exclusions include active/planned pregnancy, cancer treatment (except certain skin cancers), non-chronic pain opioid use, hospice care, recent suicidal intent or misuse of controlled medications.

Inclusion Criteria

I take 90mg or less of pain medication daily.

My doctor agrees with me joining the trial and prescribes opioids for chronic pain.

Ability to provide consent

Exclusion Criteria

I am currently using methadone or buprenorphine.

I am currently undergoing or planning to start cancer treatment, excluding hormonal therapy and treatments for non-melanoma skin cancers.

Known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either continued opioid therapy or undergo slow tapering of opioid doses

12 months

Visits at baseline, 3 months, 6 months, 9 months, and 12 months

Follow-up

Participants are monitored for changes in pain, quality of life, depression, and anxiety

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Slow Tapering of Chronic Opioid Therapy

Trial Overview The study tests if very slow tapering of opioids worsens pain, quality of life, depression or anxiety in patients on stable long-term doses for chronic pain. It aims to understand the effects of reducing opioid medication gradually over time.

How Is the Trial Designed?

Group I: Slow Tapering of Chronic Opioid Therapy Experimental Treatment 1 Intervention

Subjects who are on a stable dose of daily opioid therapy for at least 6 months will have their opioid medication doses slowly and gradually reduced every 4 weeks.

Group II: Continued Opioid Therapy Active Control 1 Intervention

Subjects who are on a stable dose of daily opioid therapy for at least 6 months will stay on the same dose of opioids they are currently using at the beginning of the study for the entire 12-month duration of the study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6857102/

Stopping or Decreasing Opioid Therapy in Patients on ... A good plan for a slow taper is to decrease the patient's total daily dose of opioids by 5–20% every 4 weeks.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05297396

Slow Opioid Tapering Pilot Study of Patients Using Chronic ... The purpose of this study is to find out if patients who have been taking a stable dose of opioids for chronic pain would experience any worsening pain, quality ...

3. bjanaesthesia.org.uk bjanaesthesia.org.uk/article/S0007-0912(24)00472-0/fulltext

Effectiveness of pain medication tapering in chronic ... An overall effect size of 0.917 (95% confidence interval 0.61–1.22; P<0.001) was found, indicating a beneficial effect of tapering. In addition, ...

4. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1004123

Discontinuation and tapering of prescribed opioids and risk of ... Tapering opioid therapy for pain was associated with decreased overdose risk among people with opioid use disorder not receiving opioid agonist ...

5. nam.edu nam.edu/perspectives/best-practices-research-gaps-and-future-priorities-to-support-tapering-patients-on-long-term-opioid-therapy-for-chronic-non-cancer-pain-in-outpatient-settings/

Best Practices, Research Gaps, and Future Priorities to ... An opioid taper can cause a CNCP patient with a history of chronic opioid therapy to lose tolerance to the original prescribed dose, which increases the ...

6. cdc.gov cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm

CDC Clinical Practice Guideline for Prescribing Opioids ... This guideline provides recommendations for clinicians providing pain care, including those prescribing opioids, for outpatients aged ≥18 years.

7. journalofethics.ama-assn.org journalofethics.ama-assn.org/article/nonconsensual-tapering-high-dose-opioid-therapy-justifiable/2020-08

Is Nonconsensual Tapering of High-Dose Opioid Therapy ... This article argues that nonconsensual dose reductions for stable opioid therapy patients is impermissible because it both puts a patient at risk and wrongs an ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2755492

Dose Tapering Among Patients Prescribed Long-term ... The CDC guideline recommended gradual dose reduction when tapering (ie, approximately 10% per week, possibly slower for patients with long-term ...