Skip to content

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.

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26472
Enrollment
60
Registered
2009-08-10
Start date
2009-01-09
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cocaine addiction, cocaine verslaving, ADHD, methylphenidate, methylfenidaat

Interventions

1. 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.

Sponsors

Crunelle CL, Booij J, Van den Brink W
Lead Sponsor

Eligibility

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.

Exclusion criteria

Exclusion criteria: 1. 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 (¡Ý3x 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).

Design outcomes

Primary

MeasureTime frame
To 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.

Contacts

Public ContactCleo L. Crunelle

Academic Medical Center, University of Amsterdam Amsterdam Institute for Addiction Research Department of Psychiatry, PB0-436 P.O. Box 75867

c.l.crunelle@amc.uva.nl+31 (0)20 8913763

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)