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Apomorphine Effects on Experimental Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01744964
First Posted: December 7, 2012
Last Update Posted: September 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rambam Health Care Campus
  Purpose
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.

Condition Intervention Phase
Healthy Drug: Apomorphine Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Alterations in the Ability to Tolerate Experimental Pain by Apomorphine and Its Association With a Dopamine Transporter Polymorphism

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Cold pain tolerance [ Time Frame: 120 minutes ]

Enrollment: 105
Study Start Date: July 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline
Assessment of experimental pain models before and after treatment
Drug: Apomorphine
1.5 mg Apomorphine
Other Name: Active Comparator: Apomorphine
Active Comparator: Apomorphine
Assessment of experimental pain models before and after treatment
Drug: Apomorphine
1.5 mg Apomorphine
Other Name: Active Comparator: Apomorphine

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744964


Locations
Israel
Rambam Health Care Campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Elon Eisenberg, MD Rambam Health Care Campus, Haifa, Israel
  More Information

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01744964     History of Changes
Other Study ID Numbers: 0078-09-RBM
First Submitted: December 6, 2012
First Posted: December 7, 2012
Last Update Posted: September 16, 2016
Last Verified: September 2016

Keywords provided by Rambam Health Care Campus:
apomorphine
dopamine transporter gene
SLC6A3
cold pressor test
tolerance
experimental pain
dopamine agonist

Additional relevant MeSH terms:
Dopamine
Dopamine Agents
Apomorphine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Emetics
Gastrointestinal Agents
Dopamine Agonists