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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Post-op Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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placebo patch

Neupro® transdermal patch/placebo randomly allocated like a flip of a coin applied to your skin at the dose of 8 mg/day or a matching placebo patch after the oral surgery procedure is completed.

Group Type PLACEBO_COMPARATOR

Neupro® transdermal patch/placebo

Intervention Type DRUG

8mg transdermal patch Neupro® transdermal patch/placebo

Neupro® transdermal patch

Neupro® transdermal patch/placebo randomly allocated like a flip of a coin applied to your skin at the dose of 8 mg/day or a matching placebo patch after the oral surgery procedure is completed.

Group Type EXPERIMENTAL

Neupro® transdermal patch/placebo

Intervention Type DRUG

8mg transdermal patch Neupro® transdermal patch/placebo

Interventions

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Neupro® transdermal patch/placebo

8mg transdermal patch Neupro® transdermal patch/placebo

Intervention Type DRUG

Other Intervention Names

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also known as rotigotine

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Raymond Dionne

Raymond A. Dionne, DDS, PhD Research Professor Department of Pharmacology & Toxicology Brody School of Medicine Department of Foundational Sciences School of Dental Medicine East Carolina University Greenville, NC 27834-4354

Responsibility Role PRINCIPAL_INVESTIGATOR