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Apomorphine Effects on Experimental Pain

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ClinicalTrials.gov Identifier: NCT01744964
Recruitment Status : Completed
First Posted : December 7, 2012
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Apomorphine Early Phase 1

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  (Clinical Trial)
Actual Enrollment : 105 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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


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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.


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

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01744964     History of Changes
Other Study ID Numbers: 0078-09-RBM
First Posted: December 7, 2012    Key Record Dates
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
Apomorphine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Emetics
Gastrointestinal Agents
Dopamine Agonists