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MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients - 3 Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients - 3 conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients - 3 Clinical research trials and MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients - 3 health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients - 3. MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients - 3 Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients - 3 clinical trial. Participants oftentimes recieve the most expert healthcare available for their MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients - 3 condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients - 3  MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients - 3
MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients - 3
For Condition: Cocaine-Related Disorders
Status: Completed
Sponsor(s): National Institute on Drug Abuse (NIDA) , Cincinnati MDRU
Synopsis: 1) To demonstrate the feasibility of methylphenidate (MPD) as effective and safe in the outpatient treatment of cocaine-dependent patients with a comorbid DSM-IV diagnosis of ADHD. 2) To demonstrate the ability of each site to participate in a subsequent anticipated controlled trial of MDP (recruitment and execution). 3) To gather preliminary data on the ability of sweat patches to detect episodes of cocaine use.
Details: Forty-one participants were enrolled into this multi-site, outpatient, open-label, ten-week trial. Participants were scheduled to attend three visits per week to allow safety and efficacy measures to be taken. In addition, participants were given two hours of individual substance abuse therapy during the first four weeks, and one hour per week during the last six weeks, of the trial. All participants were started on a total daily dose of 20 mg MPD. The total daily dose was then increased to a maximum daily dose of 60 mg (20 mg TID) or to the maximum dose tolerated by the participant.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Uncontrolled
Minimum Age/Maximum Age: 21 Years/50 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 1. Subject must be between 21 and 50 years of age, male or female, of any race. 2. If female, subject cannot be pregnant or lactating. 3. Subject must be cocaine-dependent (as determined by the SCID and a clinical interview by a psychiatrist). 4. Subject must meet DSM-IV diagnostic criteria for ADHD: 5. Subject must have been actively using cocaine, (BE>300 ng/ml) within 30 days of the screening examination. 6. Subject must be negative for cocaine metabolites immediately prior to receiving a study treatment number and initial dose of MPD, as determined first by urine testing kit with result later confirmed by laboratory urine toxicology (BE < 300 ng/ml). 7. Subject must be willing and able to give informed consent. Exclusion Criteria: 1. Subject has symptoms of AIDS. 2. Subject has a chronic medical disorder requiring medication. 3. Subject has a SCID Axis-I psychiatric diagnosis requiring medication. 4. Subject meets DSM-IV criteria for dependence for any substance except cocaine, alcohol, nicotine, marijuana, caffeine, and has been actively using during the past two weeks. 5. Subject is in need of detoxification from alcohol or benzodiazepines 6. Subject is taking psychotropic medication (except chloral hydrate for insomnia). 7. Subject is female of childbearing age who is at risk for becoming pregnant and is not using adequate contraceptive techniques as determined by the evaluating physi cian or Principal Investigator. 8. Subject has ALT or AST levels above three times laboratory normal 9. Subject has renal function tests (creatinine and BUN) or electrolyte levels (K, Na, Cl, HCO3) that are not within normal limits at baseline. 10. Subject has an EKG indicating clinically significant arrhythmias or abnormal conduction 11. Subject has organic brain syndrome (OBS) as evidenced in the psychiatric evaluation. 12. Subject has an acute or chronic medical or psychiatric condition which in the judgment of the evaluating physician would make study participation difficult or unsafe. 13. Subject has been enrolled in another research protocol within the past 45 days. 14. Subject has narrow angle glaucoma, by history 15. Subject has a diagnosis or family history of Tourettes syndrome 16. Subject has a history of seizures or seizure disorder 17. Subject has had an adverse reaction to methylphenidate 18. Subject has abnormal thyroid function (as determined by an abnormal T4 level that is clinically significant) 19. Subject has been treated for ADHD with psychomotor stimulants within the past month. 20. Subject plans to receive psychosocial treatment external to that designated in the protocol during study participation.
Total Enrollment: 20
Location and Contact Information:
Overall Study Official:
EugeneSomoza, Principal Investigator, Cincinnati MDRU
Cincinnati MDRU
Cincinnati, Ohio, 45220
United States
Additional Information:
Study ID Numbers: NIDA-5-0012-3;
Study Start Date: September 1998
Record last reviewed: February 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015054
Other Cocaine-Related Disorders Studies:
1. Serotonin/Dopamine Antagonism of Cocaine Effect - 1
2. Potential Interactions between IV Cocaine and RPR 102681 - 1
3. Methyphendidate in the Treatment of Cocaine Dependent Patients with Adult ADHD - 5
4. Phase 2, Double-Blind, Placebo-Controlled Trial of Reserpine for the Treatment of Cocaine Dependence - 1
5. Early Phase II Trials for Cocaine Medication Development - 1
Related Studies:
Other Cocaine-Related Disorders Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials
MPD04961-Methylphendidate Treatment of Cocaine Dependent ADHD Patients - 3
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