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

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Opiate Dependent; Previous Illicit Drug Use

Treatments: Drug: Buprenorphine and Methadone Hydrochloride

Study type: Observational

Funder types: Other

Identifiers

NCT01560442

CHU-0117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

buprenorphine

Treatment:

Drug: Buprenorphine and Methadone Hydrochloride

Methadone Hydrochloride

Treatment:

Drug: Buprenorphine and Methadone Hydrochloride