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Acute Pain Management in Patients on Opioid Replacement Therapy

NCT03933865 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-10-10

No results posted yet for this study

Summary

This is an outpatient randomized within subject placebo-controlled human laboratory investigation of analgesia (as assessed with quantitative sensory testing; QST) from ketamine alone and in combination with hydromorphone in buprenorphine maintained participants. The goals of this project are to characterize the analgesic, subjective, and physiologic effects of ketamine combined with hydromorphone in patients on buprenorphine maintenance for opioid use disorder.

Conditions

  • Opioid-use Disorder
  • Pain, Acute

Interventions

DRUG

HYDROmorphone Injectable Solution

Hydromorphone will be given via intramuscular injection (8 mg)

DRUG

Ketamine

Ketamine will be given via intramuscular injection (0.1, 0.2 or 0.4 mg/kg)

DRUG

Placebos

Placebo will be normal saline solution given via intramuscular injection.

Sponsors & Collaborators

Principal Investigators

  • D. Andrew Tompkins, MD MHS · University of California, San Francisco

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2022-02-24
Completion
2022-02-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03933865 on ClinicalTrials.gov