Study to Assess Dopamine Receptor Modulation With Rotigotine to Enhance Morphine Analgesia in the Dental Model

Post-op Pain Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Randomized, Parallel Group Study to Assess Dopamine Receptor Modulation With Rotigotine to Enhance Opioid Analgesia Using the Oral Surgery Model of Acute Pain in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02123979
• Other study ID #: 14-000723
• Secondary ID: 112101 668916
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 14, 2014
• Last updated: August 6, 2015
• Start date: November 2015
• Est. completion date: January 2017

Study information

• Verified date: August 2015
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Narcotics are widely used as the mainstay of pain treatment, although increasing doses are required over time as the individual becomes tolerant to their effects. This can lead to the development of dependence and abuse of these drugs. Research has identified a new way to decrease the risk of developing tolerance to narcotics, by giving at the same time a drug called rotigotine ("Neupro"). Rotigotine interferes with the body's chemical dopamine and is FDA-approved for the management of Parkinson's Disease.

The purpose of this research study is to look at side effects and pain control in healthy people after removal of wisdom teeth, which usually causes pain. It is thought that by giving the study drug rotigotine with the narcotic pain reliever, there will be pain control that will extend longer than when giving the narcotic alone.

Description:

Inclusion Criteria:

• Male and female patients aged 18 and over scheduled to undergo elective oral surgery for the removal of impacted third molars

• Indicated for the removal of 3-4 third molars, at least two of which are categorized as partial-boney or full-boney impactions

• Self-report of moderate or severe pain on a categorical scale with a minimum of 5 out of 10 on the numerical rating scale following the offset of local anesthesia

Exclusion Criteria:

• History or intolerance to rotigotine

• Current or history of mental disorder or substance abuse

• Allergy or intolerance to opioids or local anesthetics

• Concurrent or recent use of agents that may confound the sedative effects of the study drug (opioids, benzodiazepines) over the previous 7 days or alcohol ingestion in the previous 24 hours

• Chronic or recent use of medications that might confound the effects of rotigotine, e.g., antihistamines, prescription or over-the-counter NSAIDs (Nonsteroidal anti-inflammatory drugs), acetaminophen, steroids, antidepressants, muscle relaxants.

• Concurrent or history of chronic diseases, e.g., diabetes, rheumatoid arthritis, liver disease, cancer, hypertension or obesity (body mass index >35).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• • Male and female patients aged 18 and over scheduled to undergo elective oral surgery for the removal of impacted third molars

• Indicated for the removal of 3-4 third molars, at least two of which are categorized as partial-boney or full-boney impactions

• Self-report of moderate or severe pain on a categorical scale with a minimum of 5 out of 10 on the numerical rating scale following the offset of local anesthesia

Exclusion Criteria:

• History or intolerance to rotigotine

• Current or history of mental disorder or substance abuse

• Allergy or intolerance to opioids or local anesthetics

• Concurrent or recent use of agents that may confound the sedative effects of the study drug (opioids, benzodiazepines) over the previous 7 days or alcohol ingestion in the previous 24 hours

• Chronic or recent use of medications that might confound the effects of rotigotine, e.g., antihistamines, prescription or over-the-counter NSAIDs, acetaminophen, steroids, antidepressants, muscle relaxants.

• Concurrent or history of chronic diseases, e.g., diabetes, rheumatoid arthritis, liver disease, cancer, hypertension or obesity (body mass index >35).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-op Pain

Intervention

Drug:
• Neupro® transdermal patch/placebo
8mg transdermal patch Neupro® transdermal patch/placebo

Locations

Country	Name	City	State
United States	School of Dental Medicine At East Carolina University	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	assess pain	assess the translational potential of what has been demonstrated in the lab to human subjects experiencing painful conditions that require control with morphine. We hope to provide proof of concept for a treatment strategy that will allow opiates to maintain their effectiveness at low doses without the emergence of tolerance and other side effects, even with prolonged use.	up 48 hours	Yes
Primary	Sum of pain intensity difference scores	The primary outcome measure will be the SPID (sum of pain intensity difference scores) over the 3-hour observation period for MS(morphine sulfate)+Nuepro versus MS.	up to six months	Yes
Secondary	Analgesic tablets taken postoperatively	The number of analgesic tablets taken over the first 48 hours postoperatively will be compared between the two groups as a secondary measure of the ability of the D3 agonist to potentiate opioid analgesia as a surrogate indicator of reduced potential for tolerance development.	December 2014	Yes