Ignite Creation Date:
2024-05-05 @ 10:14 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01067846
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
2010-02-10
Brief Title:
Cognitive Enhancement and Relapse Prevention in Cocaine Addiction
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
The Clinical and Neural Response of Cocaine Addicts to Combination Treatment With a Cognitive Enhancer and Extinction-Based Psychotherapy
Status:
COMPLETED
Status Verified Date:
2013-10
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:
For this project the investigators are interested in exploring a new way to extend and maintain drug abstinence in people who are addicted to crack cocaine This study will combine a medication called D-Cycloserine DCS and weekly cognitive behavioral therapy CBT to assess whether the combination will enhance peoples ability to stay clean drug free for longer periods of time
One of the greatest risks for drug relapse is drug craving Oftentimes drug craving occurs when a person is confronted with stressors and reminders of past drug use behavior DCS has been shown to enhance the learning of new information By administering DCS prior to learning new techniques such as how to cope with drug craving and drug-use reminders it is possible that patients can be more successful at living a drug free life for a longer period of time
In addition to exploring this model behaviorally the investigators will explore changes that may occur in the brain before and after the therapymedication intervention A technique called MRI Magnetic Resonance Imaging will be used to identify areas of the brain that are being activated during an attention task Areas of neural activation will be assessed at study entry end of therapy 4-week endpoint and one month following completion of the treatment program
One of the greatest risks for drug relapse is drug craving Oftentimes drug craving occurs when a person is confronted with stressors and reminders of past drug use behavior DCS has been shown to enhance the learning of new information By administering DCS prior to learning new techniques such as how to cope with drug craving and drug-use reminders it is possible that patients can be more successful at living a drug free life for a longer period of time
In addition to exploring this model behaviorally the investigators will explore changes that may occur in the brain before and after the therapymedication intervention A technique called MRI Magnetic Resonance Imaging will be used to identify areas of the brain that are being activated during an attention task Areas of neural activation will be assessed at study entry end of therapy 4-week endpoint and one month following completion of the treatment program
Detailed Description:
Primary Hypothesis
Enhancing glutamatergic neurotransmission with DCS facilitates CBT-related relapse prevention by potentiating the behavioral and neural representation of the diminished drug motivation associated with cocaine cues
Specific Aims
1 Determine if the short-term oral administration of DCS relative to placebo prior to CBT sessions facilitates cocaine abstinence and functional recovery and reduces cocaine craving in treatment-seeking cocaine addicts
2 Determine if DCS administration relative to placebo facilitates CBT-related decreases in the behavioral and neural response to conditioned cocaine cues
Enhancing glutamatergic neurotransmission with DCS facilitates CBT-related relapse prevention by potentiating the behavioral and neural representation of the diminished drug motivation associated with cocaine cues
Specific Aims
1 Determine if the short-term oral administration of DCS relative to placebo prior to CBT sessions facilitates cocaine abstinence and functional recovery and reduces cocaine craving in treatment-seeking cocaine addicts
2 Determine if DCS administration relative to placebo facilitates CBT-related decreases in the behavioral and neural response to conditioned cocaine cues
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 |
|---|---|---|---|
| R21DA025243 | NIH | None | httpsreporternihgovquickSearchR21DA025243 |