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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborator:
CSAPA ANPAA 63
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01560442
First received: March 20, 2012
Last updated: January 11, 2013
Last verified: January 2013

March 20, 2012
January 11, 2013
February 2012
July 2013   (final data collection date for primary outcome measure)
Measurement of the pupil diameter [ Time Frame: 24 hours after the last dose of treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01560442 on ClinicalTrials.gov Archive Site
  • - The mechanical punctuate pain threshold as measured by Electronical Von Frey [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • - The mechanical pressure pain threshold measured by Algometer on the tibial bone [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • - The pupil diameter measured in scotopic .conditions (via infrared camera) at the hypothetical peak effect of either methadone or buprenorphine. [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • - The pupil diameter measured in photopic conditions (via infrared camera) at the hypothetical residual effect of either methadone or buprenorphine [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine
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.

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.

Observational
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Opiate dependent patients

  • Opiate Dependent
  • Previous Illicit Drug Use
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.
  • buprenorphine
    Intervention: Drug: Buprenorphine and Methadone Hydrochloride
  • Methadone Hydrochloride
    Intervention: Drug: Buprenorphine and Methadone Hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr
France
 
NCT01560442
CHU-0117
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
CSAPA ANPAA 63
Principal Investigator: Nicolas AUTHIER University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP