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Apomorphine Effects on Experimental Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01744964
First received: December 6, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  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
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Cold pain tolerance [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

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
Active Comparator: Apomorphine
Assessment of experimental pain models before and after treatment
 Drug: Apomorphine
1.5 mg 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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01744964     History of Changes
Other Study ID Numbers: 0078-09-RBM
Study First Received: December 6, 2012
Last Updated: December 6, 2012
Health Authority: Israel: Ethics Commission

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

Additional relevant MeSH terms:
Apomorphine
Dopamine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiotonic Agents
Cardiovascular Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013