Acute Pain Episodes in Patients Under Opioid Maintenance Therapy : Clinical Management and Long Term Effects

This study has been completed.
Sponsor:
Collaborator:
French Health Products Safety Agency
Information provided by:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00738036
First received: August 19, 2008
Last updated: November 23, 2009
Last verified: November 2009
  Purpose

To define a rational pharmacological management of pain for the subjects under opioid maintenance therapy (methadone or buprenorphine), it is first of all necessary to estimate the efficiency of the current practices on pain management as well as their potentially noxious consequences, in particular on the long term opioid maintenance therapy.

The objective of the study is to compare the efficiency of the opioid maintenance therapy according to the arisen of an acute painful phenomenon requiring an analgesic management for these patients. At first, this work will allow to determine the results on acute pain of the current practices for these patients. The comparison of the long term consequences on opioid maintenance therapy between the patients that presented an acute painful phenomenon and the control patients should help to improve acute pain management for these patients while limiting the risk of relapse in the abused consumption of psychoactive substances.


Condition
Acute Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Pain Episodes in Patients Under Opioid Maintenance Therapy : Clinical Management and Long Term Effects

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Retention rate under buprenorphine or methadone treatment defined as the percentage of patients still under treatment during the follow-up [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain, anxiety, drugs, alcohol and other substances abuse and dependence, drug prescription (included for pain treatment and opioid maintenance) [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: April 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group P
Exposed to an acute painful phenomenon requiring an analgesic management
Group C
Control, not exposed to acute pain

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients under opioid maintenance therapy

Criteria

Inclusion Criteria:

  • Patients aged 18 or more.
  • Patients under opioid maintenance therapy (buprenorphine or methadone)
  • Patients treated by the same drug (buprenorphine or methadone) since at least 3 months

Exclusion Criteria:

  • Refusal of the patient to take part in the study
  • Absence of possible follow-up
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00738036

Locations
France
University Hospital Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
French Health Products Safety Agency
Investigators
Study Director: Maryse Lapeyre-Mestre, MD University Hospital, Toulouse
  More Information

No publications provided by University Hospital, Toulouse

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Llau ME, University Hospital Toulouse
ClinicalTrials.gov Identifier: NCT00738036     History of Changes
Other Study ID Numbers: 0700107
Study First Received: August 19, 2008
Last Updated: November 23, 2009
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Toulouse:
Analgesics
Opioid
Opioid maintenance therapy
Acute pain

Additional relevant MeSH terms:
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 20, 2014