Introduction of Long Acting Buprenorphine in France

NCT06266039 | Recruiting

• 2 other identifiers: 2022-0328-012022-A02616-37
• Study Type: observational
• Target: 223
• Locations: 1 country
• Sites: 1

Brief Summary

The current available pharmacological treatment formulations (i.e., daily formulations of buprenorphine or methadone) for OUD in France may have several inconveniences, such as: compliance, burden of daily intake, and risk of misuse; that may hinder their effectiveness. Long acting formulations of buprenorphine (LAB) such as Buvidal have been developed to favor retention and compliance and minimize the risk of diversion. Previous studies are promising on the advantage of LAB to treat opioid addiction, however more evidence is needed in the French healthcare context. However, in addition to randomized clinical trials, the French National Healthcare Agency (HAS "Haute Autorité de Santé") recommends conducting "real-life" studies (i.e., in naturalistic conditions) during the development of a medication and the use of "Patient Reported Outcome Measures" (PROMs) to analyze patient quality of life and/or other measures relevant to patients (e.g., severity, efficiency), without interpretation of the answers by a health professional. In this regard, our study proposes to use the Addiction Severity Index (ASI) self-report questions and several scales on treatment satisfaction and quality of life to collect the patient's opinion of perceived changes following the use of Buvidal. Main objectives: The objectives of this prospective open observational study, in naturalistic conditions, are to examine in individuals with an opioid use disorder, over a period of 6 months after LAB treatment initiation: the change in substance addiction severity and the changes in health-related quality of life, craving, opioids and other substance and non-substance uses and misuses, alcohol, tobacco and non-substance addiction severity, satisfaction with LAB treatment, severity of others domains related to addiction severity (i.e., medical, social, psychological) and psychiatric comorbidities Main hypotheses:

1. 1.Hypothesize was that LAB will be associated with a stable (if prior remission) or a reduction of the CS of "Drug use" (i.e., substance addiction severity) at 6 months compared to baseline.
2. 2.Hypothesize was that LAB will be associated with a stable (if prior remission) or a reduction of opioids and other substance and non-substance uses and misuses, other substances and non-substances addiction severity, craving, severity of others domains related to addiction (i.e., medical status, employment and support, family/social status, psychological status), an improvement of quality of life and a good satisfaction with treatment at follow-ups compared to baseline.

Conditions

Addiction Opiate

Keywords

opioid use disorder (OUD); patient reported outcome measure (PROM); addiction severity index (ASI); long acting buprenorphine

Outcome Measures

Primary Outcomes (1)

• The change in the composite score of the "Drug use" section from the Addiction Severity Index (ASI) at 6 months after treatment initiation

  The main outcome criteria will be the change in substance addiction severity (i.e., composite score of "Drug section" of the ASI which is a standard multidimensional measure, range from 0 "no drug problem" to 1 "extreme drug problem") during the first 6 months of LAB treatment initiation in individuals with an opioid use disorder, in the French health care context.

  At 6 months compared to baseline

Secondary Outcomes (10)

• The change in addiction severity at 6 months after treatment initiation

  At 6 months compared to baseline

• The change in quality of life with EuroQoL-5 Dimensions-5 Levels (EQ-5DL-5L) at 6 months after treatment initiation

  At 6 months compared to baseline

• The change in quality of life with the 12-Item Short Form Survey (SF-12) at 6 months after treatment initiation

  At 6 months compared to baseline

• The change in quality of life with nottingham health profile part 1 and part 2 (NHP1 and NHP2) at 6 months after treatment initiation

  At 6 months compared to baseline

• The change in quality of life with assisted quality of life assessment chart (TEAQV) at 6 months after treatment initiation

  At 6 months compared to baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants included in this observational study in the French healthcare context will be recruited from the current prescribers of LAB, which are medical doctors working in Addiction Treatment Centers (i.e., Centre de Soins, d'Accompagnement et de Prévention en Addictologie (CSAPA), services hospitaliers d'addictologie) in France.

You may qualify if:

• To have been prescribed LAB
• To plan to initiate a LAB treatment in the following month
• To be over 18 years of age
• To accept to participate after an informed consent procedure

You may not qualify if:

• To be under guardianship, curatorship or safeguard of justice
• To have a difficulty understand / reading the French language
• To have any condition incompatible with study participation (e.g., not being able to communicate by phone)

Sponsors & Collaborators

• University of Bordeaux: lead

Study Sites (1)

University of Bordeaux

Bordeaux, Gironde, 33000, France

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Marc Auriacombe, Professor

CONTACT

+33556561738; marc.auriacombe@u-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: February 20, 2024
• Study Start: March 31, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

FR (1)