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

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	150
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2010 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738036

Contacts


Contact: Maryse LAPEYRE-MESTRE, MD	33-5 62 26 06 90	lapeyre@cict.fr

Locations


France
	University Hospital Toulouse	Recruiting
	Toulouse, France, 31059
	Contact: Maryse Lapeyre-Mestre, MD 33-5 62 26 06 90
	Sub-Investigator: Vincent BOUNES, MD
	Sub-Investigator: Agnès LAFFORGUE, MD
	Sub-Investigator: Marie CREQUY, MD

Sponsors and Collaborators

University Hospital, Toulouse

French Health Products Safety Agency

Investigators


Study Director:	Maryse Lapeyre-Mestre, MD	University Hospital, Toulouse

More Information

Responsible Party:	University Hospital Toulouse ( Llau ME )
Study ID Numbers:	0700107
First Received:	August 19, 2008
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00738036
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Toulouse:

Analgesics

Opioid

Opioid maintenance therapy

Acute pain

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on October 15, 2008

Sponsors and Collaborators:	University Hospital, Toulouse French Health Products Safety Agency
Information provided by:	University Hospital, Toulouse
ClinicalTrials.gov Identifier:	NCT00738036