Study to Investigate Whether AFQ056 Reduces Cocaine Use in Patients Diagnosed With Cocaine Use Disorder (CUD)
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Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Understand the study procedures and provide written informed consent before any assessment is performed.
Subjects diagnosed with Cocaine Use Disorder according to DSM 5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Ed.).
Must use cocaine through snorting (intranasally) as primary route of administration.
Recent cocaine use confirmed by positive urine screen for 1 or more benzoylecgonine (BE).
Must be seeking treatment for cocaine dependence and have a desire to reduce or cease cocaine use.
Has current diagnosis of Substance Use Disorder (according to the DSM 5) on alcohol, cannabis or other stimulants, except cocaine.
Meets current or lifetime DSM 5 criteria for schizophrenia or any psychotic disorder, or organic mental disorder.
Have current treatment for Substance Use Disorder (e.g.: disulfiram, acamprosate, methyl phenidate, modafinil, topiramate, immediate release dexamfetamine,or baclofen).
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
Have a history of any illness, condition, and use of medications that in the opinion of the investigator or designee might confound the results of the study or pose additional risk in administering the investigational agents to the subject or preclude successful completion of the study
Current or/and previous treatment with concomitant medications that are strong or moderate inducers/inhibitors of CYP3A4 (e.g., clarithromycin, ketoconazole, ritonavir, etc.)
History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV).
Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the CSSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to to respect the privacy of patients who have participated in the trail in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalsutdydatarequest.com.
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Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cocaine Use Disorder; cocaine dependence
Additional relevant MeSH terms:
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Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action