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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 October 2021
• Main ID: NCT03242928
• Date of registration: 04/08/2017
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Study to Investigate Whether AFQ056 Reduces Cocaine Use in Patients Diagnosed With Cocaine Use Disorder (CUD)
• Scientific 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)
• Date of first enrolment: December 4, 2017
• Target sample size: 68
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03242928
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Argentina, Spain, Switzerland

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cocaine-related Disorder

Intervention(s)

Drug: AFQ056

Drug: Placebo

Primary Outcome(s)

Proportion of Cocaine Use Days [Time Frame: Day 1 up to day 98]

Secondary Outcome(s)

Proportion of Positive Urine Measurements of Benzoylecgonine (BE) [Time Frame: Day 1 up to day 98]

AFQ056 Plasma Concentrations [Time Frame: Day 15 (0h, 2h), Day 29 (0, 2h), Day 57 (0h, 2h), Day 98 (0h,2h)]

Proportion of Days of Alcohol Consumption [Time Frame: Day 1 up to day 98]

Secondary ID(s)

2017-000736-33

CAFQ056X2201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/02/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03242928