Efficacy of Co-administration of an NSAID With a Dopamine Agonist In Healthy Subjects

October 9, 2014 updated by: Apkar Apkarian, Northwestern University

Study of the Efficacy of Co-administration of an NSAID With a Dopamine Agonist in the Alleviation of Acute Cutaneous Inflammatory Pain in Healthy Subjects

Findings from the investigator's lab and others' show the involvement of the brain's mesolimbic circuitry in pain perception and evaluation, as well as during the transition from acute to chronic pain states in both humans and animals. Dopamine (DA) is one of the main neurotransmitters in this circuitry, and it is possible it could have an intimate role in pain processing, chronicity, and related anatomical and functional neuroplasticity. In this study, the investigators first need to know if the combination of l-dopa and Naproxen is safe and efficacious in humans with acute pain, and if so, at what doses. For the present study, healthy pain-free participants will be injected with a small bolus of capsaicin subcutaneously to induce acute cutaneous inflammatory pain. Capsaicin is ideal for this study because it causes a characteristic inflammatory response that is almost always accompanied with pain, has a well-validated dose-response curve, and has effects that will go away completely in a few hours after administration, causing no permanent damage to study subjects. Effects of capsaicin will be measured by changes (decreases) from baseline in thermal and tactile thresholds, as well as by verbally reported cutaneous pain levels (on a scale from 0-10). Participants will also be given study medication in the form of a placebo, one drug, or a combination of drugs before capsaicin injection to allow for any analgesic effects to peak before pain onset. For those receiving active medication, they will either receive Naproxen with placebo or the combination of naproxen and l-dopa (the latter of which will be in one of two different doses). This will allow the investigators to investigate (1) whether co-administration of naproxen and l-dopa has analgesic effects in low levels of acute pain in humans, (2) if this combination is pain-alleviating, whether it is equally as or more efficacious than naproxen, which is the clinical standard of treatment, and finally (3) what dose provides the most analgesia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be currently healthy and have none of the exclusion criteria listed below.
  • Must be at least 18 years of age.
  • Must be able to communicate (speak and write) in English.
  • Must demonstrate that they understand what the study entails and requires of them.
  • Must be able to dedicate the amount of time (~3 hours) to participate in the study.

Exclusion Criteria:

  • History of chronic pain of any kind
  • Have a current episode of acute pain of any kind (including stomach ache, headache, muscle ache, etc)
  • History of psychiatric illness or brain injury
  • History of substance abuse
  • History of motor impairments
  • History of another chronic disease (such as heart disease, celiac's, bronchial asthma, etc)
  • Have a diagnosis of narrow-angle glaucoma
  • History or presence of high blood pressure
  • History or presence of melanoma cancer
  • Currently on a high-protein diet
  • Women who are pregnant, trying to get pregnant, or breastfeeding
  • Known or suspected allergies to capsaicin, peppers, levodopa, carbidopa, naproxen, NSAIDs, rubbing alcohol (in the medical wipes), or lidocaine
  • History or presence of dermatological disorder, including contact dermatitis and a history of skin allergies in general
  • Presence of a skin lesion in the areas to be tested

Prohibited Medication:

  • Aliskiren
  • ACE inhibitors
  • Angiotensin 2 receptor blockers
  • Cidofovir
  • Corticosteroids
  • Anti-platelet drugs
  • Blood-thinners
  • Another NSAID
  • MAOIs
  • Tetrabenazine
  • Anti-depressants
  • Anti-psychotics
  • Metoclopramide
  • Phenytoin
  • Papaverine
  • Sedatives or muscle relaxers
  • Tryptan/L-tryptophan
  • DA agonists/antagonists

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control Group
10 participants will be given two pills: both will be placebos
Drug: Placebo
Subjects will take two placebos.
Other Names:
  • Sugar Pill
Active Comparator: Standard Treatment / Positive Control Group
10 participants will be given two pills: both will be Naproxen (each pill = 250mg, total dose = 500mg)
Drug: Naproxen
Subjects will take one 250mg Naproxen capsule
Other Names:
  • Aleve
  • Naprosyn
  • Anaprox
  • Antalgin
  • Apranax
  • Feminax Ultra
  • Flanax
  • Inza
  • Midol Extended Relief
  • Nalgesin
  • Naposin
  • Naprelan
  • Naprogesic
  • Narocin
  • Proxen
  • Soproxen
  • Synflex
  • Xenobid
Active Comparator: Experimental Group #1
10 participants will be given two pills: one will be Naproxen (250 mg) and the other will be of Sinemet (carbidopa/levodopa 12.5mg/50mg)
Drug: Naproxen
Subjects will take one 250mg Naproxen capsule
Other Names:
  • Aleve
  • Naprosyn
  • Anaprox
  • Antalgin
  • Apranax
  • Feminax Ultra
  • Flanax
  • Inza
  • Midol Extended Relief
  • Nalgesin
  • Naposin
  • Naprelan
  • Naprogesic
  • Narocin
  • Proxen
  • Soproxen
  • Synflex
  • Xenobid
Drug: Sinemet
Subjects will take one 12.5mg/50mg Sinemet.
Other Names:
  • Carbidopa/levodopa
  • Atamet
  • Levocarb
  • Pharmacopa
  • Apo-Levocarb
  • Co-careldopa
Drug: Sinemet
Subjects will take one 25mg/100mg Sinemet.
Other Names:
  • Carbidopa/levodopa
  • Atamet
  • Levocarb
  • Pharmacopa
  • Apo-Levocarb
  • Co-careldopa
Active Comparator: Experimental Group #2
10 participants will be given two pills: one will be Naproxen (250 mg) and the other will be of Sinemet (carbidopa/levodopa 25mg/100mg )
Drug: Naproxen
Subjects will take one 250mg Naproxen capsule
Other Names:
  • Aleve
  • Naprosyn
  • Anaprox
  • Antalgin
  • Apranax
  • Feminax Ultra
  • Flanax
  • Inza
  • Midol Extended Relief
  • Nalgesin
  • Naposin
  • Naprelan
  • Naprogesic
  • Narocin
  • Proxen
  • Soproxen
  • Synflex
  • Xenobid
Drug: Sinemet
Subjects will take one 12.5mg/50mg Sinemet.
Other Names:
  • Carbidopa/levodopa
  • Atamet
  • Levocarb
  • Pharmacopa
  • Apo-Levocarb
  • Co-careldopa
Drug: Sinemet
Subjects will take one 25mg/100mg Sinemet.
Other Names:
  • Carbidopa/levodopa
  • Atamet
  • Levocarb
  • Pharmacopa
  • Apo-Levocarb
  • Co-careldopa

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
VAS pain scale
Time Frame: 1 Day
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Apkar V Apkarian, PhD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU00083465
  • R01DE022746 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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