Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136734
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2005-08-25
Brief Title:
Methylphenidate Treatment for Cocaine Abuse and ADHD - 1
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Methylphenidate Treatment for Cocaine Abuse and ADHD
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Many cocaine dependent individuals are also diagnosed with Attention Deficit Hyperactivity Disorder ADHD Methylphenidate Ritalin is currently approved to treat individuals diagnosed with ADHD The purpose of this study is to determine the effectiveness of methylphenidate in treating ADHD symptoms in cocaine dependent individuals
Detailed Description:
Methylphenidate MPH is commonly used to treat individuals diagnosed with ADHD The purpose of this study is to determine the effectiveness of MPH in treating adult cocaine dependent individuals who are also diagnosed with ADHD
Participants in this 14-week double-blind placebo-controlled study will be randomly assigned to receive either sustained-release MPH or placebo All participants will receive individual cognitive behavioral therapy The trial will last 14 weeks It will include a 1-week placebo lead-in phase and a 2-week dose titration phase followed by 11 weeks on a stable dose of MPH During the titration phase MPH will be given twice a day starting at a dose of 10 mgday The dose will increase by 10 mg each day until a final stable dose of 40 mgday is reached At this time sustained-release MPH will be given as two 20 mg doses one in the morning and one in the afternoon Depending on a participants tolerance of MPH the dose will be increased to a maximum of 60 mgday 40 mg in the morning and 20 mg in the afternoon Participants who are unable to tolerate a dose of at least 40 mgday of MPH will be discontinued from the study Assessments of ADHD symptoms will be completed at weekly study visits In addition drug use assessments will also be completed and will include self-reports and urine toxicology tests
Participants in this 14-week double-blind placebo-controlled study will be randomly assigned to receive either sustained-release MPH or placebo All participants will receive individual cognitive behavioral therapy The trial will last 14 weeks It will include a 1-week placebo lead-in phase and a 2-week dose titration phase followed by 11 weeks on a stable dose of MPH During the titration phase MPH will be given twice a day starting at a dose of 10 mgday The dose will increase by 10 mg each day until a final stable dose of 40 mgday is reached At this time sustained-release MPH will be given as two 20 mg doses one in the morning and one in the afternoon Depending on a participants tolerance of MPH the dose will be increased to a maximum of 60 mgday 40 mg in the morning and 20 mg in the afternoon Participants who are unable to tolerate a dose of at least 40 mgday of MPH will be discontinued from the study Assessments of ADHD symptoms will be completed at weekly study visits In addition drug use assessments will also be completed and will include self-reports and urine toxicology tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA011755 | NIH | None | httpsreporternihgovquickSearchR01DA011755 |