Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05886582
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-04-27
Brief Title:
Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Phase 2a Double-Blind Placebo-Controlled Trial of Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This is a randomized double-blind placebo-controlled phase 2b pilot clinical trial to determine whether non-ergoline D3D2D1 dopamine DA receptor agonist rotigotine RTG in combination with treatment as usual including individual or group behavioral therapy can a reduce cocaine use and also b increase brain activity in frontocortical areas of the brain and as a reflection of that - improve top-down cognitive control in persons with cocaine use disorder CocUD
Rotigotine is a marketed non-ergoline D3D2D1 DA agonist RTG Neupro in the form of a transdermal patch that is FDA-approved for the treatment of Parkinsons Disease and Restless Legs Syndrome The premise of this project was based on apparent beneficial effects of RTG in a different human population characterized by executive function EF impairment In light of the deficits in EF common in persons with CocUD RTG may hold the potential for cognitive improvement in persons with CocUD who are in treatment as usual to both attend to and retain psychoeducation concepts better In addition rotigotine may help these individuals in recovery maintain goals better where goal maintenance is a crucial integrative product of successful EF
Rotigotine is a marketed non-ergoline D3D2D1 DA agonist RTG Neupro in the form of a transdermal patch that is FDA-approved for the treatment of Parkinsons Disease and Restless Legs Syndrome The premise of this project was based on apparent beneficial effects of RTG in a different human population characterized by executive function EF impairment In light of the deficits in EF common in persons with CocUD RTG may hold the potential for cognitive improvement in persons with CocUD who are in treatment as usual to both attend to and retain psychoeducation concepts better In addition rotigotine may help these individuals in recovery maintain goals better where goal maintenance is a crucial integrative product of successful EF
Detailed Description:
Among different substance use disorders stimulant use disorders are more consistently linked with impaired executive function EF of the brain which is a set of cognitive skills like working memory that operate to enable self-control over behavior and long-term planning Medications such as stimulants that increase function of the frontal cortex dopamine DA system can improve EF However stimulants such as amphetamine have abuse potential Of interest is determining whether a multiple DA receptor medication like rotigotine could improve brain function in persons with stimulant use disorder who are in therapy to help them retain educational concepts and strategies better Rotigotine has been shown to improve cognition-related quality of life in persons with Alzheimers Disease This is a roughly six week trial of rotigotine given in a skin patch to determine whether it not only reduces cocaine use in persons in treatment for cocaine use disorder but actually improves cognitive performance itself and increases activity in the frontal cortex of the brain compared to placebo It is hypothesized that rotigotine will be specifically helpful for cognition and abstinence in those participants whose cognitive performance ability tested at baseline is below the median
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 1U01DA057846-01 | NIH | None | httpsreporternihgovquickSearch1U01DA057846-01 |