Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218543
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2005-09-20
Brief Title:
Atomoxetine for Treating Cocaine Abuse in Adults With Attention Deficit Hyperactivity Disorder ADHD
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Atomoxetine Treatment for Cocaine Abuse and Adult Attention-Deficit Hyperactivity Disorder ADHD A Preliminary Open Trial
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:
Atom
Brief Summary:
Studies have shown that individuals with attention deficit hyperactivity disorder ADHD are at greater risk for having a substance use disorder compared to people who do not have ADHD Rates of cocaine abuse in adults with ADHD are significantly higher than they are in adults who do not have ADHD Some clinicians suggest that adults with ADHD may abuse cocaine in order to self-medicate their ADHD symptoms Atomoxetine is a drug that has been effective in treating ADHD This study will evaluate the effectiveness of atomoxetine in reducing cocaine use in people with ADHD who abuse cocaine
Detailed Description:
ADHD is a neurologic disorder that is thought to be caused by chemical imbalances of certain neurotransmitters in the brain The disorder can cause inattention hyperactivity and impulsivity Cocaine abuse rates in adults with ADHD are significantly higher than they are in adults who do not have the disorder This may be reflective of an attempt by individuals with ADHD to self-treat symptoms Atomoxetine is an FDA-approved drug that is used to increase the ability to pay attention and decrease impulsiveness and hyperactivity in children and adults with ADHD The drug is in a class of medications called selective norepinephrine reuptake inhibitors and works by increasing the levels of norepinephrine a natural substance in the brain that affects a persons attention and impulsivity It is possible that reducing ADHD symptoms in cocaine abusers with ADHD will help decrease their need for cocaine This study will evaluate the effectiveness of atomoxetine in reducing cocaine use in people with ADHD who abuse cocaine
Participants in this open label study will receive atomoxetine for 12 weeks and will take one dose each morning for the duration of the study Doses will be increased gradually to minimize side effects and enhance treatment compliance In addition all participants will receive individualized relapse prevention therapy once weekly Participants will be required to report to the study site three times a week to receive medication complete questionnaires regarding ADHD symptoms and substance use behavior and provide a urine sample while being supervised by study staff Also vital signs will be monitored and medication side effects will be assessed at each visit Participants will report to the study site 6 months after starting in the study for a follow-up visit at which time ADHD symptoms substance use behavior and social functioning will be assessed
Participants in this open label study will receive atomoxetine for 12 weeks and will take one dose each morning for the duration of the study Doses will be increased gradually to minimize side effects and enhance treatment compliance In addition all participants will receive individualized relapse prevention therapy once weekly Participants will be required to report to the study site three times a week to receive medication complete questionnaires regarding ADHD symptoms and substance use behavior and provide a urine sample while being supervised by study staff Also vital signs will be monitored and medication side effects will be assessed at each visit Participants will report to the study site 6 months after starting in the study for a follow-up visit at which time ADHD symptoms substance use behavior and social functioning will be assessed
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 |
|---|---|---|---|
| DPMC | US NIH GrantContract | None | httpsreporternihgovquickSearchP50DA009236 |
| P50DA009236 | NIH | None | None |
| P50-09236-12 | None | None | None |