Apomorphine Effects on Experimental Pain

September 15, 2016 updated by: Rambam Health Care Campus

Alterations in the Ability to Tolerate Experimental Pain by Apomorphine and Its Association With a Dopamine Transporter Polymorphism

The aims of this study were to assess the effects of the dopamine agonist apomorphine on experimental pain models in healthy subjects and to explore the possible association between these effects and a common polymorphism within the dopamine transporter gene.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Healthy volunteers (n=105) participated in this randomized double-blind, placebo-controlled, cross-over trial. Heat pain threshold and intensity, cold pain threshold, and the response to tonic cold pain (latency, intensity, and tolerance) were evaluated before and for up to 120 min after the administration of 1.5 mg apomorphine/placebo. A polymorphism (DAT-1) within the dopamine transporter gene (SLC6A3) was investigated.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Health Care Campus

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

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- healthy and free from chronic pain of any type did not use any medications other than oral contraceptives were able to understand the purpose and instructions of the study.

Exclusion Criteria:

- any type of medical or painful condition use of medications or recreational drugs pregnancy.

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Saline
Assessment of experimental pain models before and after treatment
Drug: Apomorphine
1.5 mg Apomorphine
Other Names:
  • Active Comparator: Apomorphine
ACTIVE_COMPARATOR: Apomorphine
Assessment of experimental pain models before and after treatment
Drug: Apomorphine
1.5 mg Apomorphine
Other Names:
  • Active Comparator: Apomorphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cold pain tolerance
Time Frame: 120 minutes
120 minutes

Collaborators and Investigators

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

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Elon Eisenberg, MD, Rambam Health Care Campus, Haifa, Israel

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

July 1, 2009

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

December 6, 2012

First Submitted That Met QC Criteria

December 6, 2012

First Posted (ESTIMATE)

December 7, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 16, 2016

Last Update Submitted That Met QC Criteria

September 15, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0078-09-RBM

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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