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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
December 6, 2012
December 7, 2012
September 16, 2016
July 2009
July 2011   (Final data collection date for primary outcome measure)
Cold pain tolerance [ Time Frame: 120 minutes ]
Same as current
Complete list of historical versions of study NCT01744964 on ClinicalTrials.gov Archive Site
Not Provided
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Apomorphine Effects on Experimental Pain
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.
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.
Interventional
Early Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy
Drug: Apomorphine
1.5 mg Apomorphine
Other Name: Active Comparator: Apomorphine
  • Placebo Comparator: Saline
    Assessment of experimental pain models before and after treatment
    Intervention: Drug: Apomorphine
  • Active Comparator: Apomorphine
    Assessment of experimental pain models before and after treatment
    Intervention: Drug: Apomorphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
July 2011
July 2011   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01744964
0078-09-RBM
No
Not Provided
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Rambam Health Care Campus
Rambam Health Care Campus
Not Provided
Principal Investigator: Elon Eisenberg, MD Rambam Health Care Campus, Haifa, Israel
Rambam Health Care Campus
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP