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

December 6, 2012
December 6, 2012
July 2009
July 2011   (final data collection date for primary outcome measure)
Cold pain tolerance [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy
Drug: Apomorphine
1.5 mg apomorphine
  • Placebo Comparator: Saline
    Assessment of experimental pain models before and after treatment
  • 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.

Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01744964
0078-09-RBM
No
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
December 2012

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