Study of the Characteristics of Chronic Pain in Patients With Addiction (ADDICTALGO)

May 7, 2025 updated by: Alexandre Cauchie, Groupe Hospitalier de Bretagne Sud

Descriptive, Prospective Study of the Characteristics of Chronic Pain in Patients With Addiction to at Least One Substance

It is described in the literature a higher prevalence of pain in patients with an addiction but there are few studies describing the pain profile of patients with use disorder.

Pain has a very negative impact on the quality of life of opioid substituted patients. Improving knowledge on this point would make it possible to better guide specific care.

The investigator proposes to conduct a single-center descriptive observational study using questionnaires, without changing the management of patients with chronic pain.

The primary objective of the study is to determine the prevalence of chronic pain in patients with substance addiction hospitalized for addiction treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

It is described in the literature a higher prevalence of pain in patients with an addiction but there are few studies describing the pain profile of patients with use disorder.

Pain has a very negative impact on the quality of life of opioid substituted patients. Improving knowledge on this point would make it possible to better guide specific care.

The investigator proposes to conduct a single-center descriptive observational study using questionnaires, without changing the management of patients with chronic pain. All patients admitted to hospitalization in the addiction department of the LORIENT Hospital will be offered participation in the study.

The primary objective of the study is to determine the prevalence of chronic pain in patients with substance addiction hospitalized for addiction treatment.

The study will also evaluate the impact on daily activities of the presence of two chronic pathologies: chronic pain and addiction, describe the frequency of the two main psychiatric comorbidities of chronic pain: anxiety and depression, describe the different components of chronic pain in patients with substance addiction, and get information on analgesic medications.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Lorient, France, 56100
        • Groupe Hospitalier Bretagne Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized in the addictology department of LORIENT Hospital, in full hospitalization or in a day hospital

Description

Inclusion Criteria:

  • > 18 years old
  • Presence of addiction to at least one substance, based on DSM-5 criteria
  • Hospitalized in the addiction service of LORIENT Hospital
  • Knowing how to read and write French
  • Not objecting to their participation in the study after informed information

Exclusion Criteria:

  • Already included during a precedent hospitalization
  • Adults subject to legal protection or deprived of their liberty.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of chronic pain in patients with substance addiction hospitalized for addiction treatment.
Time Frame: During the hospitalization, maximum 1 month
Percentage of patients presenting with pain for more than three months among patients hospitalized in an addiction service for the management of an addiction
During the hospitalization, maximum 1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain intensity in the last 24 hours
Time Frame: During the hospitalization, maximum 1 month
Results of the Brief Pain Inventory : worst and least of pain in the last 24 hours
During the hospitalization, maximum 1 month
Interference of pain on the quality of life
Time Frame: During the hospitalization, maximum 1 month
Result of Brief pain inventory on general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. On a scale from 0 (does not interfere) to 10 (completely interferes)
During the hospitalization, maximum 1 month
Localisation of pain
Time Frame: During the hospitalization, maximum 1 month
Drawing on a diagram of a human body
During the hospitalization, maximum 1 month
Describe the frequency of the two main psychiatric comorbidities of chronic pain: anxiety
Time Frame: During the hospitalization, maximum 1 month
Results of the anxiety scale of Hospital Anxiety and Depression scale. Positive if > 8. Minimum 0, maximum 21
During the hospitalization, maximum 1 month
Describe the frequency of the two main psychiatric comorbidities of chronic pain: depression
Time Frame: During the hospitalization, maximum 1 month
Results of the depression scale of Hospital Anxiety and Depression scale. Positive if > 8. Minimum 0, maximum 21
During the hospitalization, maximum 1 month
Describe the prevalence of fibromyalgia among patients with substance addiction
Time Frame: During the hospitalization, maximum 1 month
Results of the Fibromyalgia Rapid Screening Tool. Suspicion of fibromyalgia if >5 yes. Maximum 6 yes
During the hospitalization, maximum 1 month
Information on analgesics medication
Time Frame: During the hospitalization, maximum 1 month
Collection of current analgesic medication taken every day
During the hospitalization, maximum 1 month
Describe the prevalence of neuropathic pain among patients with substance addiction
Time Frame: During the hospitalization, maximum 1 month
Results of the DN3 (neuropathic pain 3). Suspicion of neuropathic pain when > 3/7
During the hospitalization, maximum 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Groupe Hospitalier de Bretagne Sud

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexandre Cauchie, MD, GH Bretagne Sud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 56LORC_2021_ADDICTALGO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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