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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03242928
Recruitment Status : Active, not recruiting
First Posted : August 8, 2017
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This will assess whether AFQ056 can have a beneficial effect by reducing cocaine use in Cocaine Use Disorder (CUD) patients as assessed by Timeline Follow-Back cocaine self-report.

Condition or disease Intervention/treatment Phase
Cocaine-related Disorder Drug: AFQ056 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : January 8, 2020
Estimated Study Completion Date : January 8, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Tablets

Experimental: AFQ056 Drug: AFQ056
Tablets




Primary Outcome Measures :
  1. The primary objective is to evaluate the effect of AFQ056 in reducing cocaine use. [ Time Frame: Daily from screening (Day-28 to -9) to Day 113 ]
    The Timeline Follow-Back (TLFB) cocaine self-report is an assessment method that obtains estimates of daily cocaine intake and has been evaluated with clinical and nonclinical populations.


Secondary Outcome Measures :
  1. To assess the effects of on other measures of cocaine use [ Time Frame: Days: 28 to -9; -10 to -8; -7 to -4; -3 to -1; 1; 4; 8; 11; 15; 18; 22; 25; 29; 32; 36; 39; 43; 46; 50; 53; 57; 60; 64; 67; 71; 74; 78; 81; 85; 88; 92; 95; 98; 99; 102; 106; 112; 113 ]
    Urine sample will be analyzed for the presence of cocaine metabolite's Benzoylecgonine (BE) the main metabolite of cocaine present in urine.

  2. To assess the effects on alcohol use [ Time Frame: Daily from screening (Day-28 to -9) to Day 113 ]
    The Timeline Follow-Back (TLFB) alcohol is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations.

  3. AFQ056 plasma concentrations [ Time Frame: Day 15 (0h, 2h), Day 29 (0, 2h), Day 57 (0h, 2h), Day 98 (0h,2h) ]
    Plasma samples will be collected to assess PK.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03242928


Locations
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Argentina
Novartis Investigative Site
Buenos Aires, Argentina, 1058
Novartis Investigative Site
Buenos Aires, Argentina, 4634
Novartis Investigative Site
Buenos Aires, Argentina, C1405B0A
Spain
Novartis Investigative Site
San Juan de Alicante, Alicante, Spain, 03550
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08003
Novartis Investigative Site
Barcelona, Spain, 08036
Switzerland
Novartis Investigative Site
Basel, Switzerland, 4025
Novartis Investigative Site
Zuerich, Switzerland, 8001
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03242928     History of Changes
Other Study ID Numbers: CAFQ056X2201
2017-000736-33 ( EudraCT Number )
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cocaine Use Disorder; cocaine dependence
Additional relevant MeSH terms:
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Disease
Cocaine-Related Disorders
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents