Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine

Opiate Dependent Clinical Trial

— PUPIDOL  

Official title:

Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01560442
• Other study ID #: CHU-0117
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2012
• Last updated: January 11, 2013
• Start date: February 2012
• Est. completion date: October 2013

Study information

• Verified date: January 2013
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Opiate Dependent
• Previous Illicit Drug Use

Intervention

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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	CSAPA ANPAA 63

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of the pupil diameter		24 hours after the last dose of treatment	Yes
Secondary	- 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	Yes
Secondary	- 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	Yes
Secondary	- 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	Yes
Secondary	- 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	Yes