Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000317
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
1999-09-20
Brief Title:
Early Phase II Trials for Cocaine Medication Development - 1
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Early Phase II Trials for Cocaine Medication Development
Status:
COMPLETED
Status Verified Date:
2017-06
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:
The purpose of this study is to develop models for early Phase II testing of potential medications for cocaine dependence amoxapine risperidone and other agents
The study was a controlled pilot trial of risperidone in opiate-dependent patients on methadone maintenance The study explored whether risperidone reduced cocaine use cocaine craving and cocaine subjective effects in patients on methadone maintenance who abused cocaine and whether it had an acceptable side effect profile This
The study was a controlled pilot trial of risperidone in opiate-dependent patients on methadone maintenance The study explored whether risperidone reduced cocaine use cocaine craving and cocaine subjective effects in patients on methadone maintenance who abused cocaine and whether it had an acceptable side effect profile This
Detailed Description:
This was an 18-week prospective randomized placebo-controlled crossover design with placebo lead-in phase and terminal placebo phase After two weeks of single-blind placebo patients were randomly assigned to one of two schedules of medication
2 Week Baseline Weeks 1-6 Weeks 7-12 Weeks 13-18 Group 1 placebo risperidone placebo placebo Group 2 placebo placebo risperidone placebo
The first 6-week phase provided an initial double-blind medication-placebo comparison In the second six-week phase weeks 7-12 patients crossed over to the opposite treatment During weeks 13-18 Group 1 patients remained on placebo while Group 2 patients were tapered from risperidone to placebo For six weeks after the end of the trial patients were offered routine clinical treatment with counseling and psychiatrist visits as needed Medication dosage was titrated upwards on a fixed-flexible schedule to a maximum dose of 4 mg per day Medication began at ½ mg risperidone for 3 days then 1 mg for four days 2 mg per day during week 2 3 mg per day during week 3 and 4 mg per day during weeks 4-6 The titration schedule for risperidone in weeks 7-12 was the same as for weeks 1-6 In addition to treatment as usual patients received a modified manual-guided relapse prevention counseling program in weekly meetings lasting approximately 20 minutes these sessions provided cognitive and behavioral skills that were found to be helpful to patients in reducing cocaine use
2 Week Baseline Weeks 1-6 Weeks 7-12 Weeks 13-18 Group 1 placebo risperidone placebo placebo Group 2 placebo placebo risperidone placebo
The first 6-week phase provided an initial double-blind medication-placebo comparison In the second six-week phase weeks 7-12 patients crossed over to the opposite treatment During weeks 13-18 Group 1 patients remained on placebo while Group 2 patients were tapered from risperidone to placebo For six weeks after the end of the trial patients were offered routine clinical treatment with counseling and psychiatrist visits as needed Medication dosage was titrated upwards on a fixed-flexible schedule to a maximum dose of 4 mg per day Medication began at ½ mg risperidone for 3 days then 1 mg for four days 2 mg per day during week 2 3 mg per day during week 3 and 4 mg per day during weeks 4-6 The titration schedule for risperidone in weeks 7-12 was the same as for weeks 1-6 In addition to treatment as usual patients received a modified manual-guided relapse prevention counseling program in weekly meetings lasting approximately 20 minutes these sessions provided cognitive and behavioral skills that were found to be helpful to patients in reducing cocaine use
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 |
|---|---|---|---|
| R01DA009582 | NIH | None | httpsreporternihgovquickSearchR01DA009582 |