It is not really a medical condition that is being investigated. The present research proposal has been designed 1) to assess creativity during cocaine intoxication, and 2) to define the potentially different effect of cocaine on divergent and convergent thinking in cocaine users
Conditions
Interventions
Product Name: Cocaine HCl
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Cocaine HCl
CAS Number: 53-21-4
Current Sponsor code: Cocaine HCl
Other descriptive name: COCAINE HYDROCHLORIDE
Concen
Sponsors
Maastricht University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - subjects must have used cocaine on at least 12 separate occasions during the past two years; - good physical and mental health as determined by medical history and medical, ECG and laboratory examination; - body weight between 80 and 130% of the ideal bodyweight as defined in the Metropolitan Life Insurance tables; - use of appropriate contraception, - written informed consent; - age 18-40 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 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - pregnancy or lactation; - cardiovascular abnormalities as assessed by standard ECG; - excessive drinking; - hypertension; - history of psychiatric and neurological disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The present research proposal has been designed 1) to assess creativity during cocaine intoxication, and 2) to define the potentially different effect of cocaine on divergent and convergent thinking in cocaine users;Secondary Objective: We want to investigate the link between cocaine administration and fear recognition. We expect to find impairment of fear recognition after acute cocaine administration compared to placebo.;Primary end point(s): The study will comprise measures of divergent and convergent thinking, fear recognition, drug concentrations, hormones, questionnaires, heart rate and blood pressure. Primary endpoints will be measures of divergent and convergent thinking.;Timepoint(s) of evaluation of this end point: Each test day (gather the information); at the end of the study, merge all this information and do analyses | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The study will comprise measures of divergent and convergent thinking, fear recognition, drug concentrations, hormones, questionnaires, heart rate and blood pressure. Secondary endpoints will be questionnaires and fear recognition parameters.;Timepoint(s) of evaluation of this end point: Each test day (gather the information); at the end of the study, merge all this information and do analyses | — |
Countries
Netherlands
Contacts
Public ContactAnita van Oers
Maastricht University
Outcome results
None listed