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OpenTrials
Completed

NCT Number: NCT00738036

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Toulouse

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 20, 2008
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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