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

This study is currently recruiting participants.
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
History of Changes
  Purpose

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.


Condition Intervention
Opiate Dependent
Previous Illicit Drug Use
 Drug: Buprenorphine and Methadone Hydrochloride

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Measurement of the pupil diameter [ Time Frame: 24 hours after the last dose of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • - 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 ]

Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Opiate dependent patients

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560442

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN     04 73 75 11 95     placarin@chu-clermontferrand.fr    
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
CSAPA ANPAA 63
Investigators
Principal Investigator: Nicolas AUTHIER University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01560442     History of Changes
Other Study ID Numbers: CHU-0117
Study First Received: March 20, 2012
Last Updated: January 11, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Analgesics, opioids
Opiate substitution treatment
Methadone
Buprenorphine
Hyperalgesia
 Pupil
Pain
Psychophysics
previous illicit drug intake, under a substitution program

Additional relevant MeSH terms:
Methadone
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 19, 2013