NCT01560442

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

1.4 years

First QC Date

March 20, 2012

Last Update Submit

January 11, 2013

Conditions

Opiate DependentPrevious Illicit Drug Use

Keywords

Analgesics, opioidsOpiate substitution treatmentMethadoneBuprenorphineHyperalgesiaPupilPainPsychophysicsprevious illicit drug intake, under a substitution program

Outcome Measures

Primary Outcomes (1)

  • Measurement of the pupil diameter

    24 hours after the last dose of treatment

Secondary Outcomes (4)

  • - 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

  • - 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

  • - 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 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

Study Arms (2)

buprenorphine

Drug: Buprenorphine and Methadone Hydrochloride

Methadone Hydrochloride

Drug: Buprenorphine and Methadone Hydrochloride

Interventions

Buprenorphine and Methadone HydrochlorideDRUG

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 Hydrochloridebuprenorphine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Opiate dependent patients

You may qualify if:

  • substitution treatment stable since at least 3 months
  • capacity to understand the protocol
  • likely to come to visits
  • covered by French welfare

You may not qualify if:

  • chronic pain
  • concomitant acute pain
  • pregnancy or breast feeding
  • relevant mental disease
  • peripheral neuropathy
  • diabetes
  • regular intake of ketamine
  • neuroleptic concomitant treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

HyperalgesiaPain

Interventions

BuprenorphineMethadone

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsKetonesOrganic Chemicals

Study Officials

  • Nicolas AUTHIER

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2012

First Posted

March 22, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2013

Study Completion

October 1, 2013

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations

FR(1)