Ignite Creation Date:
2024-05-05 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00553319
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2007-11-02
Brief Title:
Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study of Mixed Amphetamine Salts Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder ADHD and Cocaine Dependence
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:
CAMP
Brief Summary:
The proposed protocol is a 3 group double-blind placebo-controlled outpatient study of the safety and efficacy of Adderall-XR ER-MAS in the treatment of comorbid ADHD and cocaine dependence Since this medication has independently shown promise in helping with ADHD and cocaine abuse we are proposing that it may be successful in the treatment of comorbid ADHD and cocaine abuse We plan to enroll 75 subjects in a 14-week trial The primary objectives of the study are to determine the efficacy of ER-MAS in promoting cocaine abstinence and improvement in ADHD symptomology among cocaine-dependent patients with comorbid ADHD
Detailed Description:
Specific Aim 1 To determine the efficacy of ER-MAS in promoting cocaine abstinence and ADHD improvement among comorbid ADHD and cocaine-dependent patients
Primary Hypothesis benzoylecgonine positive urine screens will decrease with greatest to least reductions from 80mg60mgPBO placebo
Hypothesis 2 ADHD-Rating Scale will decrease with greatest to least reductions from 80mg60mgPBO
Specific Aim 2 To determine the effect of ER-MAS on improving general functioning and impulsivity among comorbid ADHD and cocaine-dependent patients
Hypothesis 4 There will be greater improved CGI clinical global impression scale scores in participants receiving d-AMPH d-amphetamine compared to PBO
Hypothesis 5 ER-MAS will decrease impulsivity as measured by several self-report Barratts Impulsivity Scale and behavioral measures Card Sort IMT immediate memory task DMT delayed memory task BART compared to PBO
This 14-week three arm two medication doses versus PBO prospective parallel groups randomized PBO-controlled trial with a lead-in as well as medication run-up and run down weeks will provide clear data on efficacy and safety for definitive Phase III trials which if successful will lead to improved treatment for A-ADHDS-SUD
Primary Hypothesis benzoylecgonine positive urine screens will decrease with greatest to least reductions from 80mg60mgPBO placebo
Hypothesis 2 ADHD-Rating Scale will decrease with greatest to least reductions from 80mg60mgPBO
Specific Aim 2 To determine the effect of ER-MAS on improving general functioning and impulsivity among comorbid ADHD and cocaine-dependent patients
Hypothesis 4 There will be greater improved CGI clinical global impression scale scores in participants receiving d-AMPH d-amphetamine compared to PBO
Hypothesis 5 ER-MAS will decrease impulsivity as measured by several self-report Barratts Impulsivity Scale and behavioral measures Card Sort IMT immediate memory task DMT delayed memory task BART compared to PBO
This 14-week three arm two medication doses versus PBO prospective parallel groups randomized PBO-controlled trial with a lead-in as well as medication run-up and run down weeks will provide clear data on efficacy and safety for definitive Phase III trials which if successful will lead to improved treatment for A-ADHDS-SUD
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 |
|---|---|---|---|
| R01DA023652-01 | NIH | None | httpsreporternihgovquickSearchR01DA023652-01 |