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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.


- candidate number6304
- NTR NumberNTR1947
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-aug-2009
- Secondary IDsMEC 09/118 METC Academic Medical Center
- Public TitleWhy 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.
- Scientific TitleWhy 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.
- ACRONYMN/A
- hypothesisTo investigate the difference in effectiveness of methylphenidate (MPH) in the treatment of adult ADHD patients with and without comorbid cocaine dependence.
- Healt Condition(s) or Problem(s) studiedADHD, Cocain addiction, Methylphenidat
- Inclusion criteria1. 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.
- Exclusion criteria1. Currently dependent on any substance other than cocaine or nicotine;
2. Severe neurological or psychiatric disorders or diseases (e.g., psychosis, bipolar depression, Parkinson¡¯s disease, or dementia) that require psychotropic medications;
3. Serious medical illnesses that would make participation hazardous, such as cardiovascular disease or ECG abnormalities;
4. Known hypersensitivity or allergy to MPH;
5. Under therapy with drug known to influence binding to DATs, including antipsychotics, MPH, bupropion, and dexamphetamine within 30 days prior to randomization;
6. Received a drug with known potential for toxicity to a major organ system within the month prior to entering treatment;
7. Clinically significant abnormal laboratory values (¡İ3x normal) as measured by the Arkin Mental Health and Addiction treatment center;
8. Any disease of the gastrointestinal system, liver, or kidneys which could result in altered metabolism or excretion of the study medication;
9. Hypersensitivity to iodine;
10. Any contraindications to perform MR imaging (e.g., pacemaker, or any piece of metal in the body).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 9-jan-2009
- planned closingdate9-jan-2012
- Target number of participants60
- Interventions1. MPH study medication (oral; Concerta 54 mg);
2. 2 SPECT scans using the selective radioligand [123I]FP-CIT;
3. MRI scan for coregistration;
4. Neuropsychological assessments, Questionaires;
5. Blood and urine analyses.
- Primary outcomeTo compare the effects of a standard dose of methylphenidate (MPH) on Dopamine Transporter (DAT) occupancy in ADHD patients with and without cocaine dependence, in terms of:
1. Striatal occupancy of the DAT;
2. Symptoms of ADHD;
3. Neurocognitive functions associated with ADHD;
4. Drug use/craving (in the ADHD+SUD group);
5. Relations between DAT occupancy, ADHD symptoms, cognitive functions, and drug use/craving.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Cleo L. Crunelle
- CONTACT for SCIENTIFIC QUERIES Cleo L. Crunelle
- Sponsor/Initiator Academic Medical Center (AMC), Department of Psychiatry
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThe dopamine transporter (DAT) plays a fundamental role in both ADHD and substance use disorders (SUDs). DAT-selective medication, such as methylphenidate (MPH), have been shown to successfully block the DAT in ADHD patients and DAT occupancy has been associated with clinical effectiveness. In ADHD patients with SUD, however, these medications are not very effective, neither for treating ADHD nor SUD. This study is an attempt to seriously investigate one of the most plausible reasons for the difference in effectiveness of MPH in the treatment of adult ADHD patients with and without SUD. It is hypothesized that adult ADHD patients with SUD generally have higher baseline DAT availability in the basal ganglia (Jacobsen et al., 2000; Little et al., 1998, 1999; Malison et al., 1998), and that similar doses of MPH result in lower occupancy rates in adult ADHD patients with SUD compared to adult ADHD patients without SUD.
- Main changes (audit trail)
- RECORD10-aug-2009 - 11-okt-2009


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