Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Morphine

NCT04138615 | Completed Phase 1 Results FDA Drug

• 1 other identifier: STU 092017-070
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

We are examining how morphine (a commonly used pain medication) will alter responses to simulated blood loss in humans. To simulate blood loss in our research laboratory, participants will complete a test with their lower body in a custom-designed vacuum chamber for a brief period of time.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Tolerance to Simulated Hemorrhage

  Tolerance to a simulated hemorrhagic challenge will be assessed, for both the placebo and morphine limbs, by causing progressive central hypovolemia via lower-body negative pressure (LBNP). This progressive LBNP challenge will be performed until the onset of syncopal symptoms (defined as: profound bradycardia, a precipitous drop in arterial blood pressure and accompanying narrowing of pulse pressure, a sustained systolic blood pressure less than 80 mmHg, and/or subjective symptoms such as light-headedness, sweating, nausea, or dizziness). The primary variable will be the quantification of LBNP that is required to cause these symptoms. This quantification will be objectively measured via a cumulative stress index which is calculated as the sum of the product of the LBNP level and the duration of each level, until test termination (i.e., 40 mmHg x 3 min + 50 mmHg x 3 min, etc). A larger cumulative stress index represents a greater tolerance

  30 minutes from the onset of applying lower-body negative pressure

Secondary Outcomes (1)

• Pain Assessment - Algometer

  30 minutes from the onset of the protocol

Study Arms (2)

Morphine

EXPERIMENTAL

Morphine will be administered intravenously

Drug: Morphine

Placebo

PLACEBO COMPARATOR

Saline will be administered intravenously

Other: Placebo

Interventions

Morphine DRUG

Subjects will receive Morphine while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.

Morphine

Placebo OTHER

Subjects will receive saline while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Non-obese (body mass index less than 30 kg/m2)
• Body mass greater than or equal to 65 kg

You may not qualify if:

• Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
• Any known history of renal or hepatic insufficiency/disease
• Pregnancy or breast feeding
• Current smokers, as well as individuals who regularly smoked within the past 3 years
• Positive urine drug screen
• Currently taking pain modifying medication(s)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr Craig Crandall
• Organization: University of Texas Southwestern Medical Center

craigcrandall@texashealth.org

2143454623

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 24, 2019
• Study Start: November 12, 2019
• Primary Completion: January 4, 2022
• Study Completion: January 4, 2022
• Last Updated: January 12, 2023
• Results First Posted: January 12, 2023

Record last verified: 2022-12

Locations

US (1)