Opiate DependentPUPIDOLNCT01560442
Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine
An observational study of Opiate Dependent and Previous Illicit Drug Use, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opiate Dependent, Previous Illicit Drug Use
- What is being tested?
- Buprenorphine and Methadone Hydrochloride
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Opiate dependent patients
Who may be able to join
- substitution treatment stable since at least 3 months
- capacity to understand the protocol
- likely to come to visits
- covered by French welfare
Who cannot join
- chronic pain
- concomitant acute pain
- pregnancy or breast feeding
- relevant mental disease
- peripheral neuropathy
- diabetes
- regular intake of ketamine
- neuroleptic concomitant treatment
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
Official title: Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine.
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.
Read the 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.
- Conditions
- Opiate Dependent, Previous Illicit Drug Use
- Being tested
- Buprenorphine and Methadone Hydrochloride
- Keywords
- Analgesics, opioids, Opiate substitution treatment, Methadone, Buprenorphine, Hyperalgesia, Pupil, Pain, Psychophysics, previous illicit drug intake, under a substitution program
- Medical subject headings
- Hyperalgesia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| buprenorphine | Not described Receives: Drug: Buprenorphine and Methadone Hydrochloride | |
| Methadone Hydrochloride | Not described Receives: Drug: Buprenorphine and Methadone Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the pupil diameter
Measured: 24 hours after the last dose of treatment
Secondary outcomes (4)
- The mechanical punctuate pain threshold as measured by Electronical Von Frey
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate DependentStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- CSAPA ANPAA 63
- Responsible party
- Sponsor
- Investigators
- Nicolas AUTHIER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560442
- Sponsor's protocol ID
- CHU-0117
- Acronym
- PUPIDOL
- Status last verified
- Jan 2013
- First submitted
- 20 Mar 2012
- Last updated
- 14 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pupillometry and Pain Thresholds Patients Substituted by Methadone and Buprenorphine.
- ClinicalTrials.gov ID
- NCT01560442
- Acronym / sponsor ID
- PUPIDOL / CHU-0117
- Conditions
- Opiate Dependent, Previous Illicit Drug Use
- Keywords
- Analgesics, opioids, Opiate substitution treatment, Methadone, Buprenorphine, Hyperalgesia, Pupil, Pain, Psychophysics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- CSAPA ANPAA 63
- Study start
- Feb 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 22 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| buprenorphine | – | Drug: Buprenorphine and Methadone Hydrochloride |
| Methadone Hydrochloride | – | Drug: Buprenorphine and Methadone Hydrochloride |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Opiate dependent patients
Key inclusion criteria (4 listed)
- substitution treatment stable since at least 3 months
- capacity to understand the protocol
- likely to come to visits
- covered by French welfare
Key exclusion criteria (8 listed)
- chronic pain
- concomitant acute pain
- pregnancy or breast feeding
- relevant mental disease
- peripheral neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buprenorphine and Methadone HydrochlorideTo 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. | Drug | Methadone Hydrochloride, buprenorphine |
Primary outcome
Measurement of the pupil diameter
Time frame: 24 hours after the last dose of treatment
4 secondary outcomes
- 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
- 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
- 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
- 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas AUTHIER principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opiate Dependent and Previous Illicit Drug Use, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the pupil diameter (time frame: 24 hours after the last dose of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2013.