IV methadone for Opioid Use Disorder

Duke University Medical Center, Durham, NC
Opioid Use Disorder+1 More ConditionsMorphine - Drug
18 - 65
All Sexes
What conditions do you have?

Study Summary

This trial is testing a new, non-opioid pain medication to see if it can help reduce pain after surgery while also reducing the amount of opioids consumed.

Eligible Conditions
  • Opioid Use Disorder
  • Postoperative Pain

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 72 hours

Approximately 12 hours
Total intraoperative non-methadone opioid administration
Approximately 2 hours
Total PACU opioid administration
Approximately 30 days
Total 30 day post-discharge home opioid use (number of tablets)
Up to 7 days
Total 7d post-discharge home opioid use
Up to 72 hours
Total hospital non-methadone opioid administration

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

IV methadone
1 of 2
IV fentanyl, sufentanil, morphine or hydromorphone
1 of 2

Active Control

1000 Total Participants · 2 Treatment Groups

Primary Treatment: IV methadone · No Placebo Group · Phase 4

IV methadone
ActiveComparator Group · 1 Intervention: Methadone · Intervention Types: Drug
IV fentanyl, sufentanil, morphine or hydromorphoneActiveComparator Group · 4 Interventions: Morphine, Sufentanil, Fentanyl, Hydromorphone · Intervention Types: Drug, Drug, Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 72 hours

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,235 Previous Clinical Trials
3,033,069 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,300 Previous Clinical Trials
2,021,310 Total Patients Enrolled
Evan Kharasch, MDPrincipal InvestigatorDuke University

Eligibility Criteria

Age 18 - 65 · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

What risks come with injecting fentanyl, sufentanil, morphine or hydromorphone?

"Given the Phase 4 status, which signifies approval of this treatment, our team at Power regarded IV fentanyl, sufentanil, morphine or hydromorphone's safety with a score of 3." - Anonymous Online Contributor

Unverified Answer

How many participants are engaging in this experiment?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial, originally posted on November 29th 2018, is searching for 1000 participants from a singular medical centre. The information available was most recently updated August 23rd 2022." - Anonymous Online Contributor

Unverified Answer

Does the criteria for this clinical trial include participants under 30 years old?

"This trial has specified a patient age range of 18 to 65 in order to qualify for inclusion. There are 100 studies available for those younger than 18 and 541 for individuals who have passed the retirement milestone." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies for individuals to take part in this clinical trial?

"Clinicaltrials.gov has reported that this study is actively enrolling participants, with the original posting date being November 29th 2018 and its most recent update occurring on August 23rd 2022." - Anonymous Online Contributor

Unverified Answer

For what medical purposes are IV fentanyl, sufentanil, morphine or hydromorphone typically used?

"IV fentanyl, sufentanil, morphine and hydromorphone are often administered to patients under general anesthesia. These drugs can also serve as effective solutions for the amelioration of neuropathic pain, certain medical procedures, and induction anesthetic therapy." - Anonymous Online Contributor

Unverified Answer

Who is qualified to participate in this research study?

"This research trial seeks 1000 individuals suffering pain post-surgery, aged between 18 and 65. Furthermore, those hoping to enrol need to have undergone general anesthesia during their operation; they should anticipate a stay at the medical centre of less than 24 hours; and must provide their written consent." - Anonymous Online Contributor

Unverified Answer

What previous research has been conducted regarding the utilization of IV fentanyl, sufentanil, morphine or hydromorphone?

"Presently, 115 active studies are investigating IV fentanyl, sufentanil, morphine or hydromorphone. Of these trials, 28 have been classified as Phase 3. The bulk of the experiments for this drug class are situated in Boston; however 239 locations worldwide host such research initiatives." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.