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Opioid Tapering for Chronic Pain

N/A

Waitlist Available

Led By Terrence Witt, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Average daily morphine milligram equivalent (MME) dose at enrollment equal to or less than 90

Using tablet or capsule form of one or two of the designated opioid preparations daily (at least 95% of days) during the previous 6 months, anticipated long term use and no active plans for tapering. Specific opioid preparations designated for inclusion will be based on the frequency of use by patients on the Chronic Opioid Registry as well as tablet or capsule characteristics which allow encapsulation by the Research Pharmacy. Participants who have been prescribed the following oral opioids will be recruited into the study: tramadol 50mg tablet or capsule; hydrocodone-acetaminophen (APAP) 5mg-325mg tablet or capsule; hydrocodone-APAP 7.5mg-325mg tablet or capsule; hydrocodone-APAP 10mg-325mg tablet or capsule; oxycodone 5mg tablet or capsule; oxycodone 10mg tablet or capsule; oxycodone-APAP 5mg-325mg tablet or capsule; oxycodone 10mg-325mg tablet or capsule; morphine sulfate extended release 15mg tablet or capsule; morphine sulfate extended release 30mg tablet or capsule; morphine sulfate immediate release 15mg tablet or capsule; morphine sulfate immediate release 30mg tablet or capsule

Must not have

Use of methadone or buprenorphine

Active cancer treatment, other than non-melanoma dermatological cancers. This includes patients either currently receiving or planning to receive any type of cancer treatment other than hormonal therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months, 9 months, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if reducing opioids for chronic pain patients results in worsening pain, anxiety, and depression symptoms.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects from tapering opioids may include withdrawal symptoms such as increased pain sensitivity (hyperalgesia), restlessness, mood changes like anxiety or depression, sleep disturbances and physical symptoms like sweating or gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I take 90mg or less of pain medication daily.

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I have been taking a specific opioid daily for the past 6 months without plans to reduce it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using methadone or buprenorphine.

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

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I am taking an opioid that contains three or more active ingredients.

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I am prescribed opioids for reasons other than chronic non-cancer pain.

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I have used opioid pain medication in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months, 9 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months, 9 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 9 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in measures of quality of life

Secondary study objectives

Change in measures of anxiety

Change in measures of depression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Slow Tapering of Chronic Opioid TherapyExperimental Treatment1 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 TherapyActive Control1 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.

0 / 7Eligibility criteria met