Study to Investigate Whether AFQ056 Reduces Cocaine Use in Patients Diagnosed With Cocaine Use Disorder (CUD)
Condition: Cocaine-related Disorder
MeSH terms: Cocaine-Related Disorders
Intervention: AFQ056; Placebo
Intervention description: 50 mg and 100 mg tablets taken orally; Matching placebo tablets taken orally BID
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cocaine Use Disorder; cocaine dependence,AFQ056,adult, cocaine use,CUD, drug abuse, drug addiction,

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.

          -  Controlled hypertension