Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine

University Hospital, Clermont-Ferrand100 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Opiate Dependent Previous Illicit Drug Use

Interventions

Buprenorphine and Methadone HydrochlorideDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

Outcomes

Primary Outcomes

Measurement of the pupil diameter

Time frame: 24 hours after the last dose of treatment

Secondary Outcomes

- 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

Central Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95 placarin@chu-clermontferrand.fr

Data from ClinicalTrials.gov

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