Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine

• Conditions: Opiate Dependent; Previous Illicit Drug Use
• Interventions: Drug: Buprenorphine and Methadone Hydrochloride

• Registration Number: NCT01560442
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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.

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-22
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-11
• Last Update Posted: 2013-01-14
• Primary Completion: 2013-07
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Methadone Hydrochloride	Buprenorphine and Methadone Hydrochloride	-
buprenorphine	Buprenorphine and Methadone Hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Measurement of the pupil diameter	24 hours after the last dose of treatment

Secondary Outcome Measures

Name	Time	Method
- The mechanical punctuate pain threshold as measured by Electronical Von Frey	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	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.	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	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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France