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

Study Overview
=================
Brief 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.

Detailed 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).

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

Conditions
-----------------
Post-op Pain

Intervention / Treatment
-----------------
* Drug: Neupro® transdermal patch/placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo patch<br>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. | Drug: Neupro® transdermal patch/placebo<br>* 8mg transdermal patch Neupro® transdermal patch/placebo<br>* Other names: also known as rotigotine;|
| Experimental: Neupro® transdermal patch<br>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. | Drug: Neupro® transdermal patch/placebo<br>* 8mg transdermal patch Neupro® transdermal patch/placebo<br>* Other names: also known as rotigotine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |