Clinical trial NCT02123979: Study to Assess Dopamine Receptor Modulation With Rotigotine to Enhance Morphine Analgesia in the Dental Model
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Post-op Pain
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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).

Primary outcomes:
measure: Sum of pain intensity difference scores
timeFrame: up to six months
Secondary outcomes:
measure: Analgesic tablets taken postoperatively
timeFrame: December 2014
Other outcomes:
measure: assess pain
timeFrame: up 48 hours
Locations:
city: Greenville
country: United States
facility: School of Dental Medicine At East Carolina University
state: North Carolina
Study officials:
affiliation: School of Dental Medicine, East Carolina University
name: Raymond Dionne, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: