Use of Selincro and Impact on Usual Practice

NCT02492581 | Completed DMC

• 1 other identifier: #16117N
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

USE-PACT is a cohort study of patients initiating Selincro® with one-year follow-up, performed using a random sample of prescribers. The aim of the study is to evaluate the use of Selincro in real-life and its impact on alcohol consumption at one year.

Conditions

Alcohol Dependence

Keywords

Selincro; cohort; real-life; total alcohol consumption; heavy drinking days; clinical global impression-severity; EQ5D; AQoLS; Sheehan disability scale

Outcome Measures

Primary Outcomes (1)

• Relative change of Total Alcohol Consumption (TAC) between inclusion and end of follow-up at one year

  One year

Secondary Outcomes (4)

• Relative and absolute change of TAC with respect to inclusion

  at 1 month, 3 months, 6 months, 9 months and 12 months after inclusion

• At least 70% reduction in TAC with respect to inclusion

  at 1 month, 3 months, 6 months, 9 months and 12 months after inclusion

• Change in the alcohol consumption risk level according to the WHO with respect to inclusion

  at 1 month, 3 months, 6 months, 9 months and 12 months after inclusion

• Relative and absolute change of Heavy Drinking Days (HDD) with respect to inclusion

  at 1 month, 3 months, 6 months, 9 months and 12 months after inclusion

Other Outcomes (6)

• Change in CGI-Severity with respect to inclusion (according to the physician (CGI-S) & according to the Patient (CGI-P))

  at 1 month, 3 months, 6 months, 9 months and 12 months after inclusion

• Proportion of patients having attained alcohol consumption objective defined at previous consultation

  at 1 month, 3 months, 6 months, 9 months and 12 months after inclusion

• Change in family and socio-professional impact (Sheehan Disability Scale) with respect to inclusion

  at 1 month, 3 months, 6 months, 9 months and 12 months after inclusion

Interventions

Nalmefene DRUG

No intervention on the use of Selincro. The physician will prescribe Selincro following its usual practice.

Also known as: Selincro

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

Adult patients initiating Selincro because of alcohol dependence

You may qualify if:

• Adult patient (≥18 years) initiating Selincro
• Patient accepting to participate
• Patient without linguistic barrier, notably to read the information letter and to complete the self-administrated questionnaires
• Patient not included in another study susceptible to modify patient care
• Patient not under a guardianship

You may not qualify if:

• Minor patient (≤18 years)
• Patient refusing to participate
• Patient with linguistic barrier
• Patient included in another study susceptible to modify patient care
• Patient under a guardianship

Sponsors & Collaborators

• University of Bordeaux: lead
• Lundbeck France: collaborator

Study Sites (1)

University of Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Alcoholism

Interventions

nalmefene

Condition Hierarchy (Ancestors)

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

Study Officials

• Nicholas MOORE, Professor

  University of Bordeaux

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 8, 2015
• Study Start: February 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

FR (1)