Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123383
Status:
UNKNOWN
Last Update Posted:
2007-05-01
First Post:
2005-07-21
Brief Title:
Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence
Sponsor:
The University of New South Wales
Organization:
The University of New South Wales
Study Overview
Official Title:
Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence
Status:
UNKNOWN
Status Verified Date:
2006-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 study aims to evaluate the safety and efficacy of modafinil 200 mgday over 10 weeks plus a tailored cognitive behavioural therapy program in the treatment of cocaine dependence
Detailed Description:
Modafinil is a novel wake promoting agent approved in Australia for the treatment of narcolepsy Preliminary studies have suggested that modafinil may have value in the treatment of psychostimulant dependence through positive effects on mood sleep patterns concentration fatigue and drug craving It appears to be well tolerated with a low abuse liability Thirty dependent cocaine users will be randomised to 2 equal groups The experimental group will receive modafinil 200 mgday for 10 weeks and a tailored cognitive behavioural therapy program The control group will receive placebo under equivalent conditions Primary outcome will be a between group comparison of cocaine negative urine samples collected over the 10 week study period Adverse events side effects compliance retention self reported health psychosocial and drug use outcomes will also be compared between the groups
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