Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine
Information source: University Hospital, Clermont-Ferrand
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opiate Dependent; Previous Illicit Drug Use
Intervention: Buprenorphine and Methadone Hydrochloride (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University Hospital, Clermont-Ferrand Official(s) and/or principal investigator(s): Nicolas AUTHIER, Principal Investigator, Affiliation: University Hospital, Clermont-Ferrand
Overall contact: Patrick LACARIN, Phone: 04 73 75 11 95, Email: placarin@chu-clermontferrand.fr
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.
Clinical Details
Official title: Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine.
Study design: Time Perspective: Cross-Sectional
Primary outcome: Measurement of the pupil diameter
Secondary outcome: - The mechanical punctuate pain threshold as measured by Electronical Von Frey- The mechanical pressure pain threshold measured by Algometer on the tibial bone - The pupil diameter measured in scotopic .conditions (via infrared camera) at the hypothetical peak effect of either methadone or buprenorphine. - The pupil diameter measured in photopic conditions (via infrared camera) at the hypothetical residual effect of either methadone or buprenorphine
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
- diabetes
- regular intake of ketamine
- neuroleptic concomitant treatment
Locations and Contacts
Patrick LACARIN, Phone: 04 73 75 11 95, Email: placarin@chu-clermontferrand.fr
CHU Clermont-Ferrand, Clermont-Ferrand 63003, France; Recruiting Patrick LACARIN, Phone: 04 73 75 11 95, Email: placarin@chu-clermontferrand.fr
Additional Information
Starting date: February 2012
Last updated: January 11, 2013
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