TERAPY FOR COCAINE DEPENDENCE MedDRA version: 9.1 Level: LLT Classification code 10009815 Term: Cocaine addiction
Conditions
Interventions
Trade Name: REQUIP
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Ropinirole
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 250-
Trade Name: ABILIFY
Phar
Sponsors
ASL 5 di PISA-ZONA VALDERA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria Eligibility criteria for study participation are as follows: male and female out-patients, with age between 18 to 65 years, diagnosis of cocaine dependence according to the International Statistical Classification of Diseases ICD-9-CM criteria (304.20 code), including at least three preadmission urine samples positive for cocaine metabolites throughout the latest month preceding enrolment, carried out every 72-96 hours Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria are as follows: diagnosis of cocaine abuse (305.60 ICD-9-CM code), or remission of cocaine dependence (304.23 ICD-9-CM code), diagnosis of any other current Axis I Disorder (DSM-IV-TR), organic mental disorders, chronic medical illnesses, women who are pregnant or nursing (a negative pregnancy test for women is required), hyperglycemia, anamnesis of lactose intolerance or malabsorption, malignant neuroleptic syndrome, epileptic seizures. In addiction, patients at serious suicidal risk or those who had displayed significant auto-aggressive behaviour are excluded. Subjects who are on any kind of pharmacological treatment are excluded. Patients with any psychotherapy treatment, therapeutic communities treatment or detention are excluded. Exclusion criteria are not as follows: opioid dependence comorbidity if treated with a costant dosage of methadone, remission of life-time psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main goals of the project are: -to contribute to ensuring helpful data for predisposing protocols to treat cocaine addiction. -to confirm results obtained in the open-label pilot trial with ropinirole in cocaine dependence (Meini et al., in press) and to compare themselves with aripirazole efficacy reported in current literature.;Secondary Objective: Secondary objectives To evaluate and compare aripiprazole and ropinirole safety when used in cocaine dependence.;Primary end point(s): Supervised urine sample for benzoylecgonine screening, tested three times a week, every 48-72 hours. | — |
Countries
Italy
Outcome results
None listed