Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine (PUPIDOL)

Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine.

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.

Study Overview

• Status: Unknown
• Conditions: Opiate Dependent; Previous Illicit Drug Use
• Intervention / Treatment: Drug: Buprenorphine and Methadone Hydrochloride

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Opiate dependent patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
buprenorphine	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.
Methadone Hydrochloride	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of the pupil diameter	24 hours after the last dose of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
- 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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: CSAPA ANPAA 63
• Investigators: Principal Investigator: Nicolas AUTHIER, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): October 1, 2013

Study Registration Dates

• First Submitted: March 20, 2012
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (Estimate): March 22, 2012

Study Record Updates

• Last Update Posted (Estimate): January 14, 2013
• Last Update Submitted That Met QC Criteria: January 11, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Pain; Methadone; Buprenorphine; Hyperalgesia; Opiate substitution treatment; Psychophysics; Pupil; Analgesics, opioids; previous illicit drug intake, under a substitution program
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Respiratory System Agents; Antitussive Agents; Buprenorphine; Methadone
• Other Study ID Numbers: CHU-0117