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

University of North Carolina System

Status and phase: Unknown; Phase 2

Conditions: Post-op Pain

Treatments: Drug: Neupro® transdermal patch/placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02123979

14-000723

112101 668916 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

placebo patch

Placebo Comparator group

Description:

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.

Treatment:

Drug: Neupro® transdermal patch/placebo

Neupro® transdermal patch

Experimental group

Description:

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.

Treatment:

Drug: Neupro® transdermal patch/placebo