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Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine

Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01560442
Acronym
PUPIDOL
Enrollment
100
Registered
2012-03-22
Start date
2012-02-29
Completion date
2013-10-31
Last updated
2013-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opiate Dependent, Previous Illicit Drug Use

Keywords

Analgesics, opioids, Opiate substitution treatment, Methadone, Buprenorphine, Hyperalgesia, Pupil, Pain, Psychophysics, previous illicit drug intake, under a substitution program

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.

Interventions

DRUGBuprenorphine 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.

Sponsors

CSAPA ANPAA 63
CollaboratorUNKNOWN
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Measurement of the pupil diameter24 hours after the last dose of treatment

Secondary

MeasureTime frame
- The mechanical punctuate pain threshold as measured by Electronical Von Frey24 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 bone24 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 buprenorphine24 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

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026