Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218387
Status:
COMPLETED
Last Update Posted:
2019-04-10
First Post:
2005-09-16
Brief Title:
Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
CBT and Modafinil for Cocaine Addiction
Status:
COMPLETED
Status Verified Date:
2019-03
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 Modafinil a medication that enhances mood increases energy and improves concentration may be useful in preventing relapse among individuals with cocaine addiction This study will evaluate the effectiveness of modafinil in combination with cognitive behavior therapy CBT to prevent drug relapse among cocaine addicts
Detailed Description:
The development of a medication to treat cocaine addiction specifically by lessening withdrawal symptoms has been a primary focus of research Common cocaine withdrawal symptoms include depression lack of energy and poor concentration Modafinil a central nervous system stimulant is a medication that can speed up physical and mental processes in the brain It is currently used to treat narcolepsy a condition that causes excessive sleepiness Modafinil enhances mood increases energy and improves concentration in people with narcolepsy Modafinil may also cause the same effects in individuals addicted to cocaine thereby countering the symptoms of cocaine withdrawal The purpose of this study is to compare the effectiveness of modafinil plus CBT versus placebo plus CBT for treating cocaine dependence
A 2-week screening period will be followed by an 8-week treatment phase Participants will be randomly assigned to receive either 200 mg of modafinil 400 mg of modafinil or placebo on a daily basis for the 8 weeks of treatment During this time participants will be asked to report the number of days that they use and do not use cocaine This will be confirmed three times a week with urine tests Mood level of daytime sleepiness and symptoms of cocaine withdrawal and cocaine high will be evaluated Compliance with study medication will be assessed with urine and blood tests Medication side effects will be monitored through physical examinations routine lab tests ECGs and self-reports Follow-up evaluations will occur 4 and 8 weeks following the end of treatment
A 2-week screening period will be followed by an 8-week treatment phase Participants will be randomly assigned to receive either 200 mg of modafinil 400 mg of modafinil or placebo on a daily basis for the 8 weeks of treatment During this time participants will be asked to report the number of days that they use and do not use cocaine This will be confirmed three times a week with urine tests Mood level of daytime sleepiness and symptoms of cocaine withdrawal and cocaine high will be evaluated Compliance with study medication will be assessed with urine and blood tests Medication side effects will be monitored through physical examinations routine lab tests ECGs and self-reports Follow-up evaluations will occur 4 and 8 weeks following the end of treatment
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 |
|---|---|---|---|
| R01DA016368 | NIH | None | None |
| R01-16368-1 | None | None | None |
| DPMC | US NIH GrantContract | None | httpsreporternihgovquickSearchR01DA016368 |