Apomorphine Effects on Experimental Pain

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Completed

CT.gov ID

NCT01744964

Collaborator

(none)

105

Enrollment

Location

Arms

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jul 1, 2009

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Saline Assessment of experimental pain models before and after treatment	Drug: Apomorphine 1.5 mg Apomorphine Other Names: Active Comparator: Apomorphine
Active Comparator: Apomorphine Assessment of experimental pain models before and after treatment	Drug: Apomorphine 1.5 mg Apomorphine Other Names: Active Comparator: Apomorphine

Arm

Intervention/Treatment

Placebo Comparator: Saline

Assessment of experimental pain models before and after treatment

Drug: Apomorphine

1.5 mg Apomorphine

Other Names:

Active Comparator: Apomorphine

Assessment of experimental pain models before and after treatment

Drug: Apomorphine

1.5 mg Apomorphine

Other Names:

Active Comparator: Apomorphine

Outcome Measures

Primary Outcome Measures

Cold pain tolerance [120 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.