Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344565
Status:
COMPLETED
Last Update Posted:
2012-12-03
First Post:
2006-06-26
Brief Title:
A Placebo-Controlled Double-Blind Combined Treatment of Modafinil and CBT for Cocaine Dependence
Sponsor:
Research Foundation for Mental Hygiene Inc
Organization:
Research Foundation for Mental Hygiene Inc
Study Overview
Official Title:
Combined Treatment of Modafinil and Cognitive Behavioral Therapy for Cocaine Dependence
Status:
COMPLETED
Status Verified Date:
2012-11
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 test whether a cognitive behavioral therapy CBT and a medication called modafinil which is approved to treat sleep disorders will help individuals who are abusing cocaine
Detailed Description:
Chronic cocaine abuse has been documented to produce cognitive impairments in various domains The observed cognitive deficits in the substance abuse population include but are not restricted to attention concentration verbal and nonverbal memory problem solving and abstract reasoning Our recent studies IRB Protocol 3998 demonstrated that in cocaine dependent participants such cognitive deficits have been shown to 1 negatively effect retention and 2 impede the ability of the drug abuser to benefit from cognitive behavioral therapy- relapse prevention CBT-RP that requires participant to attend to novel stimuli integrate new information with existing stores and translate information into behavior change Aharonovich Hasin Nunes 2003 Aharonovich et al in press Furthermore the toxic effects of cocaine together with withdrawal symptoms such as fatigue and hypersomnia make it difficult to fully engage in any psychosocial intervention including CBT-RP
Recent findings indicate that cocaine dysregulates reward-related glutamate pathways Dackis OBrien 2003 Kalivas et al 2003 Modafinil is a medication known to improve attention increase wakefulness energy and alertness in part by increasing glutamate levels In light of this work and the negative affect of cognitive impairments on treatment outcomes testing cognitive enhancing medications that act on glutamate pathways is a novel promising strategy for improving treatment for cocaine dependence Modafinil is approved for sleep disorders and is a relatively safe medication for cocaine-dependent participants as it has a low abuse potential and has shown promise in a double blind placebo controlled trial for cocaine dependence Rush et al 2002 Jasinski 2000 Dackis et al 2005 We therefore propose a double blind placebo controlled 12-week exploratory pilot study of modafinil a wakefulness agent in conjunction with sessions of CBT-RP enhanced with motivational interviewing components
Recent findings indicate that cocaine dysregulates reward-related glutamate pathways Dackis OBrien 2003 Kalivas et al 2003 Modafinil is a medication known to improve attention increase wakefulness energy and alertness in part by increasing glutamate levels In light of this work and the negative affect of cognitive impairments on treatment outcomes testing cognitive enhancing medications that act on glutamate pathways is a novel promising strategy for improving treatment for cocaine dependence Modafinil is approved for sleep disorders and is a relatively safe medication for cocaine-dependent participants as it has a low abuse potential and has shown promise in a double blind placebo controlled trial for cocaine dependence Rush et al 2002 Jasinski 2000 Dackis et al 2005 We therefore propose a double blind placebo controlled 12-week exploratory pilot study of modafinil a wakefulness agent in conjunction with sessions of CBT-RP enhanced with motivational interviewing components
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 |
|---|---|---|---|
| K23DA016743-03 | NIH | None | httpsreporternihgovquickSearchK23DA016743-03 |