Using Probenecid to Help with Opioid Withdrawal Symptoms
Novel Use of Probenecid to Alleviate Symptoms of Opioid Withdrawal in People With Chronic Pain Undergoing Voluntary Opioid Tapering: a Pilot Study
This study is testing if probenecid can help adults with chronic pain feel better as they reduce their use of opioid medications and deal with withdrawal symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Drugs / interventions | Methotrexate |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT04939623 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to alleviate symptoms of opioid withdrawal in adults with chronic pain who are tapering off opioid medications. The study will investigate the use of probenecid, a medication traditionally used for gout, to target a specific protein in the spinal cord that contributes to withdrawal symptoms. Participants will be monitored over a twelve-week period to assess the effectiveness of probenecid in reducing withdrawal symptoms as they decrease their opioid dosage. The trial is particularly relevant in the context of the ongoing opioid crisis in Canada, affecting individuals across various demographics.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with chronic pain who are currently taking opioid medications and planning to reduce their dosage.
Not a fit: Patients with a history of certain medical conditions, such as renal calculi or G6PD deficiency, or those currently taking specific contraindicated medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for managing opioid withdrawal symptoms, facilitating safer tapering of opioid medications.
How similar studies have performed: While the use of probenecid for opioid withdrawal is a novel approach, previous studies have explored various methods to alleviate withdrawal symptoms, indicating a need for innovative solutions in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Adults with chronic pain. Age greater than or equal to 18 years on the day of enrolment.
2. Subjects are currently taking a daily opioid pain medication and planning to taper the dose.
3. Participants complete at least one voluntary opioid dose reduction in the twelve-week study period.
4. Glomerular filtration rate (GFR) \> 50 mL/min
5. Capable of providing informed consent
Exclusion Criteria:
1. Allergy to probenecid or related drugs
2. History of uric acid renal calculi, if known to be urate calculi. If unknown type, then any history of renal calculi.
3. Known G6PD deficiency
4. Active gout in any joint
5. Current use of drugs whose exposure may be prolonged, or risk of toxicity increased when used in combination with probenecid:
1. Penicillins, specifically ampicillin, penicillin G sodium, and piperacillin
2. Carbapenems, specifically doripenem and meropenem
3. Lorazepam, midazolam, nitrazepam
4. Ketorolac
5. Oseltamivir
6. Methotrexate
7. Mycophenolate
6. Current use of drugs which may mask symptoms of withdrawal:
a. Clonidine, lofexidine, tizanidine
7. Current use of drugs which may diminish the effect of probenecid:
a. High dose salicylates including greater than 325 mg PO daily of acetylsalicylic acid (ASA)
8. Pregnancy or breastfeeding
9. Any major comorbid medical condition which might impair follow-up or result in a safety risk to the participant
10. Participation in another clinical trial investigating a drug, medical device, or a medical procedure during the 30 days prior to enrolment.
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Where this trial is running
Calgary, Alberta
- Richmond Road Diagnostic and Treatment Centre — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Lori Montgomery, MD — University of Calgary
- Study coordinator: Tammy Eberle
- Email: tammy.eberle@primarycarealberta.ca
- Phone: 1-403-943-9900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.