Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine

Overview

The purpose is to study the relation between pupillary diameter measured under scotopic conditions, and the pain thresholds measured at the time of peak and residual effect of methadone/buprenorphine in opiate-dependent patients following a substitution program.

Full Title of Study: “Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: July 2013

Detailed Description

Patients substituted since at least 3 months shall be included during a regular control visit. Each session shall consist in – check for toxics in urine sample; – measurement of pupil diameter; – measurement of mechanical punctuate pain threshold; – measurement of mechanical bone pain threshold. A first session shall be done at time of residual effect of the opiate. A second session shall be done at time of peak effect of the opiate.

Interventions

  • Drug: Buprenorphine and Methadone Hydrochloride
    • To study the relation between pupillary diameter measured under scotopic conditions, and the pain thresholds measured at the time of peak and residual effect of methadone / buprenorphine in opiate-dependent patients following a substitution program.

Arms, Groups and Cohorts

  • buprenorphine
  • Methadone Hydrochloride

Clinical Trial Outcome Measures

Primary Measures

  • Measurement of the pupil diameter
    • Time Frame: 24 hours after the last dose of treatment

Secondary Measures

  • – The mechanical punctuate pain threshold as measured by Electronical Von Frey
    • Time Frame: 24 hours after the last dose of treatment, 3 hours after the last dose of methadone and 1 hour ½ after the last dose of buprenorphine
  • – The mechanical pressure pain threshold measured by Algometer on the tibial bone
    • Time Frame: 24 hours after the last dose of treatment, 3 hours after the last dose of methadone and 1 hour ½ after the last dose of buprenorphine
  • – The pupil diameter measured in scotopic .conditions (via infrared camera) at the hypothetical peak effect of either methadone or buprenorphine.
    • Time Frame: 24 hours after the last dose of treatment, 3 hours after the last dose of methadone and 1 hour ½ after the last dose of buprenorphine
  • – The pupil diameter measured in photopic conditions (via infrared camera) at the hypothetical residual effect of either methadone or buprenorphine
    • Time Frame: 24 hours after the last dose of treatment, 3 hours after the last dose of methadone and 1 hour ½ after the last dose of buprenorphine

Participating in This Clinical Trial

Inclusion Criteria

  • substitution treatment stable since at least 3 months – capacity to understand the protocol – likely to come to visits – covered by French welfare Exclusion Criteria:

  • chronic pain – concomitant acute pain – pregnancy or breast feeding – relevant mental disease – peripheral neuropathy – diabetes – regular intake of ketamine – neuroleptic concomitant treatment

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Clermont-Ferrand
  • Collaborator
    • CSAPA ANPAA 63
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nicolas AUTHIER, Principal Investigator, University Hospital, Clermont-Ferrand
  • Overall Contact(s)
    • Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr

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