Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136825
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-08-25
Brief Title:
Effectiveness of N-acetylcysteine in Treating Cocaine Dependent Individuals - 1
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
N-acetylcysteine as Treatment in Cocaine Addiction
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recent findings have suggested that N-acetylcysteine NAC substantially reduces cocaine drug-seeking behavior in formerly cocaine dependent rats The purpose of this study is to determine the safety tolerability and cue reactivity effects of NAC in cocaine dependent individuals and non-dependent healthy controls
Detailed Description:
Recent findings have suggested that N-acetylcysteine NAC substantially reduces cocaine-primed drug-seeking behavior in formerly cocaine dependent rats The purpose of this study is to determine the safety tolerability and cue reactivity effects of NAC in cocaine dependent individuals and non-dependent healthy controls
Participants in this study will include 20 non-treatment seeking cocaine dependent individuals and 12 healthy non-dependent controls Participants will be recruited via word-of-mouth and advertisements Cocaine dependent participants will undergo two 3-day hospital stays Healthy controls will be followed throughout the study on an outpatient basis All participants will be randomly assigned to receive either 600 mg of NAC or placebo Medication or placebo will be administered twice each day Participants will be evaluated for side effects throughout the study After administration of the final dose of medication or placebo participants will undergo cue reactivity testing This will include a standardized protocol of slides demonstrating cocaine acquisition use of cocaine and cocaine-related paraphernalia Before during and after cue reactivity procedures standardized behavioral and cognitive scales will be used to assess cocaine craving cocaine seeking and subjective effects of the cocaine high The following week participants will be crossed over so that they will receive the other treatment All study procedures will be performed a second time Participants will be contacted during Week 3 in order to determine if any residual side effects or adverse events occurred from the medication and treatment
Participants in this study will include 20 non-treatment seeking cocaine dependent individuals and 12 healthy non-dependent controls Participants will be recruited via word-of-mouth and advertisements Cocaine dependent participants will undergo two 3-day hospital stays Healthy controls will be followed throughout the study on an outpatient basis All participants will be randomly assigned to receive either 600 mg of NAC or placebo Medication or placebo will be administered twice each day Participants will be evaluated for side effects throughout the study After administration of the final dose of medication or placebo participants will undergo cue reactivity testing This will include a standardized protocol of slides demonstrating cocaine acquisition use of cocaine and cocaine-related paraphernalia Before during and after cue reactivity procedures standardized behavioral and cognitive scales will be used to assess cocaine craving cocaine seeking and subjective effects of the cocaine high The following week participants will be crossed over so that they will receive the other treatment All study procedures will be performed a second time Participants will be contacted during Week 3 in order to determine if any residual side effects or adverse events occurred from the medication and 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 |
|---|---|---|---|
| F32-18501-1 | None | None | None |
| DPMC | None | None | None |