Why methylphenidate is not successful in cocaine-dependent ADHD patients: a SPECT study comparing DAT before and after methylphenidate treatment in ADHD patients with and without cocaine dependence

Conditions: ADHD with and without substance use disorder (SUD)
MedDRA version: 9.1Level: LLTClassification code 10064104Term: ADHD
MedDRA version: 9.1Level: LLTClassification code 10009815Term: Cocaine addiction

Registration Number: EUCTR2009-012261-61-NL

Lead Sponsor: Academic Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures