Study to Investigate Whether AFQ056 Reduces Cocaine Use in Patients Diagnosed With Cocaine Use Disorder (CUD)

Cocaine-related Disorder Clinical Trial

Official title: A Randomized, Subject and Investigator Blinded, Placebo-controlled, Parallel Group Study to Investigate Whether AFQ056 Reduces Cocaine Use in Patients Diagnosed With Cocaine Use Disorder (CUD)

Status Completed

Clinical Trial Summary

This study assessed whether AFQ056 had a beneficial effect by reducing cocaine use in Cocaine Use Disorder (CUD) patients as assessed by Timeline Follow-Back cocaine self-report.

Clinical Trial Description

This was a randomized, subject- and Investigator-blinded, parallel-group, placebo-controlled study in subjects with CUD. The study consisted of a 17-day screening period followed by a 12-day baseline, a 98-day outpatient treatment period (14-day up-titration dose regimen followed by 84-day maintenance dose), and an End of Study evaluation visit approximately 14 days after the last study drug administration. The total duration for each subject in the study was approximately 20 weeks including screening and baseline. ;

Related Conditions & MeSH terms

• Cocaine-related Disorder
• Cocaine-Related Disorders
• Disease

• NCT number: NCT03242928
• Study type: Interventional
• Source: Novartis
• Status: Completed
• Phase: Phase 2
• Start date: December 4, 2017
• Completion date: December 16, 2019