Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223626
Status:
COMPLETED
Last Update Posted:
2012-04-19
First Post:
2005-09-13
Brief Title:
Topiramate to Reduce Cocaine Dependence
Sponsor:
Bankole Johnson
Organization:
University of Virginia
Study Overview
Official Title:
Lab Trials to Develop Medication for Cocaine Dependence
Status:
COMPLETED
Status Verified Date:
2012-04
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:
Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse Topiramate a medication which lowers dopamine levels may have the ability to diminish cocaine cravings in addicts The purpose of this study is to determine the effectiveness of topiramate in reducing cocaines rewarding effects in individuals addicted to cocaine
Detailed Description:
GABA is an inhibitory neurotransmitter that is found primarily in the brain High GABA levels result in low levels of dopamine another neurotransmitter that is the brains feel good chemical and which plays a primary role in cocaine drug addiction Cravings for cocaine can be reduced by lowering dopamine levels This makes topiramate a GABA-altering medication a potential treatment for cocaine addiction This study will evaluate the subjective behavioral and physiological effects of topiramate in individuals addicted to cocaine
Potential participants will initially attend a 4- to 6-hour screening session This will include review of medical and drug histories standardized psychological questionnaires a physical exam and blood collection Eligible participants will then be admitted to the inpatient clinic During the first day of experiment participants will receive instructions and information about the study procedures They will also undergo a physical exam an electrocardiogram standardized psychological questionnaires and blood and urine collection A single test dose of cocaine will be administered intravenously to all participants to ensure safety with continuation in the study Vital signs will be monitored hourly throughout the day
The experiment will last 25 days and will enroll 24 individuals addicted to cocaine In this three-part experiment participants will be admitted to the inpatient clinic for an 8-day study session Following this session they will be discharged from the clinic for a 1-week washout phase Participants will then return to the inpatient clinic for another 8-day study session The two study sessions will be identical During both sessions participants will first receive topiramate or placebo for 4 consecutive days While continuing to receive topiramate or placebo participants will then also receive intravenous cocaine or placebo for 3 consecutive daysParticipants will be monitored by the study physician Electrocardiograms will be used to monitor heart activity and blood will be drawn frequently to monitor levels of cocaine and topiramate Participants will complete standardized questionnaires several times each day to assess mood changes and cognitive function
Potential participants will initially attend a 4- to 6-hour screening session This will include review of medical and drug histories standardized psychological questionnaires a physical exam and blood collection Eligible participants will then be admitted to the inpatient clinic During the first day of experiment participants will receive instructions and information about the study procedures They will also undergo a physical exam an electrocardiogram standardized psychological questionnaires and blood and urine collection A single test dose of cocaine will be administered intravenously to all participants to ensure safety with continuation in the study Vital signs will be monitored hourly throughout the day
The experiment will last 25 days and will enroll 24 individuals addicted to cocaine In this three-part experiment participants will be admitted to the inpatient clinic for an 8-day study session Following this session they will be discharged from the clinic for a 1-week washout phase Participants will then return to the inpatient clinic for another 8-day study session The two study sessions will be identical During both sessions participants will first receive topiramate or placebo for 4 consecutive days While continuing to receive topiramate or placebo participants will then also receive intravenous cocaine or placebo for 3 consecutive daysParticipants will be monitored by the study physician Electrocardiograms will be used to monitor heart activity and blood will be drawn frequently to monitor levels of cocaine and topiramate Participants will complete standardized questionnaires several times each day to assess mood changes and cognitive function
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 |
|---|---|---|---|
| DPMCDA | OTHER | NIDA | httpsreporternihgovquickSearchR01DA012191 |
| R01DA012191 | NIH | None | None |