Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine.
Overview
- Phase
- Not Applicable
- Intervention
- Buprenorphine and Methadone Hydrochloride
- Conditions
- Opiate Dependent
- Sponsor
- University Hospital, Clermont-Ferrand
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Measurement of the pupil diameter
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •regular intake of ketamine
- •neuroleptic concomitant treatment
Arms & Interventions
buprenorphine
Intervention: Buprenorphine and Methadone Hydrochloride
Methadone Hydrochloride
Intervention: Buprenorphine and Methadone Hydrochloride
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(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)