Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine

NCT ID: NCT01560442

Last Updated: 2013-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Opiate Dependent Previous Illicit Drug Use

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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buprenorphine

Buprenorphine and Methadone Hydrochloride

Intervention Type DRUG

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

Buprenorphine and Methadone Hydrochloride

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSAPA ANPAA 63

UNKNOWN

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas AUTHIER

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

04 73 75 11 95

Facility Contacts

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Patrick LACARIN

Role: primary

04 73 75 11 95

Other Identifiers

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CHU-0117

Identifier Type: -

Identifier Source: org_study_id

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