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).

ovartis Farmacéutica S.A.0 sites60 target enrollmentAugust 18, 2017

ConditionsCocaine Use Disorder according to DSM 5 MedDRA version: 20.0 Level: LLT Classification code 10009815 Term: Cocaine addiction System Organ Class: 100000173266 Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cocaine Use Disorder according to DSM 5
Sponsor: ovartis Farmacéutica S.A.
Enrollment: 60
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 18, 2017

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

ovartis Farmacéutica S.A.

Eligibility Criteria

Inclusion Criteria

•1\) Understand the study procedures and provide written informed consent before any assessment is performed.
•2\) Male and female subjects, 18 to 65 years of age (inclusive) and diagnosed with Cocaine Use Disorder according to DSM 5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Ed.).
•3\) Must use cocaine through snorting (intranasally), as primary route of administration.
•4\) Recent cocaine use confirmed by positive urine screen for 1 or more benzoylecgonine (BE)
•5\) Must be seeking treatment for cocaine dependence and have a desire to reduce or cease cocaine use as per goals assessed at baseline.
•6\) Must be abstinent from cocaine use for at least 3 days preceding 1st dosing (Day 1\) as assessed by self\-report TLFB and two \*urinalysis samples at baseline.
•\* difference in BE level between two baseline's samples must decrease
•7\) Must be in good health as determined by medical history, physical examination, at screening
•8\) At screening, and baseline, vital signs (systolic and diastolic blood pressure and pulse rate) must be within the acceptable ranges by the investigator considering the cocaine's increasing effect on pulse rate in order for the subject to qualify. Investigator may be guided to use the below ranges:
•\- systolic blood pressure, 90\-150 mmHg

Exclusion Criteria

•1\) History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes.
•2\) Has current diagnosis of Substance Use Disorder (according to the DSM 5\) on alcohol, cannabis or other stimulants, except cocaine.
•3\) Meets current or lifetime DSM 5 criteria for schizophrenia or any psychotic disorder, or organic mental disorder.
•4\) Have current treatment for Substance Use Disorder (e.g.: disulfiram, acamprosate, methyl phenidate, modafinil, topiramate, immediate release dexamfetamine, or baclofen).
•5\) Requires treatment with any psychoactive medications, including any anti\-seizure medications (with an exception of medications used for short\-term treatment of insomnia)
•6\) Use of other investigational drugs at the time of screening, or within 5 half\-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.
•7\) 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
•8\) Women of child\-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing and for 30 days after last dosing of study medication.
•9\) History of Porphyria.
•10\) History or presence of malignancy of any organ system, (other than localized basal cell carcinoma of the skin or in\-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases