ADHD with and without substance use disorder (SUD) MedDRA version: 9.1 Level: LLT Classification code 10064104 Term: ADHD MedDRA version: 9.1 Level: LLT Classification code 10009815 Term: Cocaine addiction
Conditions
Interventions
Trade Name: Ritalin
Product Name: methylphenidate
Pharmaceutical Form: Tablet
INN or Proposed INN: METHYLPHENIDATE
CAS Number: 113451
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male, age 18-60 years; 2. Current DSM-IV diagnosis of adult ADHD for all participants; 3. For the ADHD+SUD group: Current DSM-IV diagnosis of cocaine dependence, but abstinent from cocaine use for at least 1 week; 4. Able to provide written informed consent and to comply with all study procedures; 5. Negative urine analyses for MPH, amphetamines and cocaine. 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: 1. Currently dependent on any substance other than cocaine or nicotine; 2. History of severe depression, i.e. depression necessitating hospitalization, a history of 2 or more recurrent episodes of depression or previous suicide attempts; 3. Severe neurological or psychiatric disorders or diseases (e.g., psychosis, bipolar depression, Parkinson’s disease, or dementia) that require psychotropic medications; 4. Serious medical illnesses that would make participation hazardous, such as cardiovascular disease or ECG abnormalities; 5. Known hypersensitivity or allergy to MPH; 6. Under therapy with drug known to influence binding to DATs, including antipsychotics, MPH, bupropion, and dexamphetamine within 30 days prior to randomization; 7. Received a drug with known potential for toxicity to a major organ system within the month prior to entering treatment; 8. Clinically significant abnormal laboratory values (=3x normal) as measured by the treatment center; 9. Any disease of the gastrointestinal system, liver, or kidneys which could result in altered metabolism or excretion of the study medication. 10. Hypersensitivity to Iodine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine why methylphenidate is not successful in cocaine-dependent ADHD patients, using SPECT to comparing DAT before and after methylphenidate treatment in ADHD patients with and without cocaine dependence;Secondary Objective: ;Primary end point(s): To determine why methylphenidate is not successful in cocaine-dependent ADHD patients | — |
Countries
Netherlands
Outcome results
None listed