Methadone for Uterine Fibroids

Recruiting at 1 trial location

Overseen By Mostafa Borahay, MD, MBA, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must not be taking: Agonist-antagonists, SSRIs, MAOIs

Disqualifiers: Chronic pain, Long-term opioid, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a pain management plan that reduces the need for long-term opioid use after a laparoscopic hysterectomy. Researchers are testing whether a single dose of methadone (an opioid pain medication) during surgery can effectively manage pain and reduce the need for additional opioids later. Participants will receive either methadone or standard short-acting painkillers during surgery. Individuals undergoing a minimally invasive hysterectomy for non-cancerous reasons, who are not experiencing chronic pain or long-term opioid use, might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on long-term opioids, certain pain medications, or specific antidepressants. It's best to discuss your current medications with the trial team.

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

Research has shown that using methadone once during surgery may effectively manage pain. In earlier studies, patients who received a single dose of methadone during surgery experienced less pain and required fewer additional painkillers afterward. This finding suggests that methadone might reduce the need for more opioids after surgery, potentially lowering the risk of opioid addiction.

Safety information from other studies indicates that methadone is generally well-tolerated for this purpose. Side effects, such as nausea and vomiting, are similar to those of other pain medications. However, most patients report good pain relief and satisfaction.

This clinical trial remains in the early stages, requiring more research to confirm these results. Based on current knowledge, methadone appears to be a safe option for managing pain during surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for uterine fibroids, which often involve hormonal therapies or surgery, methadone offers a novel approach by utilizing its properties as a long-acting opioid. Researchers are excited about methadone because it provides pain relief during surgery with just a single dose, potentially reducing the need for additional pain medications. This unique feature not only aims to improve patient comfort and recovery but also minimizes the risk of side effects associated with multiple medications.

What evidence suggests that methadone might be an effective treatment for postoperative pain after hysterectomy?

Research shows that a single dose of methadone given during surgery can effectively manage pain after laparoscopic hysterectomy, a minimally invasive procedure to remove the uterus. In this trial, participants will receive either methadone or standard shorter-acting opioids during surgery. Methadone may reduce the need for additional pain medications post-operation. Studies have found that methadone provides longer-lasting pain relief compared to shorter-acting painkillers. Patients reported less pain and greater satisfaction with methadone, experiencing fewer side effects like nausea and vomiting. This suggests that methadone could help lower the need for extra opioid prescriptions, reducing the risk of long-term opioid use and its related issues. ^{1 2 5 6 7}

Who Is on the Research Team?

Mostafa Borahay, MD, MBA, PhD

Principal Investigator

Study Principal Investigator

Are You a Good Fit for This Trial?

This trial is for individuals with a uterus, aged 18 or older, who are undergoing minimally invasive hysterectomy with ovarian preservation for benign reasons and agree to participate. It excludes those not meeting these criteria.

Inclusion Criteria

Agreeing to participate

I have a uterus.

I am having a hysterectomy for non-cancerous reasons.

Exclusion Criteria

Pregnant/breastfeeding patients

I have been using opioids for more than three months.

I am currently taking medication that includes buprenorphine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-time intra-operative dose of Methadone or standard short-acting opioids during laparoscopic or robotic hysterectomy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, mobility, satisfaction of analgesia, and total post-operative opioid requirements

1 week

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Methadone

Trial Overview The study tests if one-time intraoperative methadone can reduce the need for post-surgery opioids in patients having laparoscopic hysterectomies. One group receives methadone; another gets short-acting opioids (standard care).

How Is the Trial Designed?

Group I: Short-Acting Opioid Experimental Treatment 1 Intervention

Standard intra-operative IV shorter acting opioids

Group II: Methadone Experimental Treatment 1 Intervention

Intra-operative single dose IV Methadone (0.25 mg/kg of ideal body weight)

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06536517?intr=methadone&aggFilters=studyType:int&viewType=Table&rank=8&checkSpell=

The Effects of One-time Intraoperative Methadone During ... Single dose of intra-operative methadone is an adequate potential in treating post-operative pain after laparoscopic total hysterectomy surgeries, reducing the ...

2. withpower.com withpower.com/trial/phase-2-myofibroma-8-2024-c16eb

Methadone for Uterine Fibroids This study aims to find the optimal pain medication plan during and after laparoscopic hysterectomy to eliminate long-term opioid use.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714409001566

Recruitment and retention of women for clinical leiomyoma ... Though hysterectomy is curative, leiomyomas and their associated symptoms often recur after other treatments. Total direct cost to the U.S. health care system ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10457492/

Clinical effectiveness and safety of intraoperative methadone ... Secondary outcomes included pain intensity at rest and during coughing, patient satisfaction, postoperative nausea and vomiting, and adverse events up to 72 h ...

5. withpower.com withpower.com/clinical-trials/for-fibroids

Top Fibroids Clinical Trials | Power This study aims to determine the efficacy of a quadratus lumborum (QL) block in decreasing postoperative pain in patients undergoing myomectomy for uterine ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03908060

Study Details | NCT03908060 | Clinical Effectiveness and ... The aim of this study is to investigate the effect of a single-dose of intravenous intraoperative methadone on postoperative opioid consumption, pain and side ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37638083/

a randomised, blinded clinical trial Secondary outcomes included pain intensity at rest and during coughing, patient satisfaction, postoperative nausea and vomiting, and adverse ...