Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT01675661
Status:
COMPLETED
Last Update Posted:
2018-05-24
First Post:
2012-08-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment
Sponsor:
Medical University of South Carolina
Organization:
Study Overview
Official Title:
Achieving Cannabis Cessation: Evaluating N-Acetylcysteine Treatment (ACCENT)
Status:
COMPLETED
Status Verified Date:
2018-04
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:
ACCENT
Brief Summary:
The primary objective of this study is to evaluate the impact of N-acetylcysteine (NAC) 1200 mg versus matched placebo (PBO) twice daily, added to contingency management (CM), on cannabis use among treatment-seeking cannabis-dependent adults (ages 18-50).
Detailed Description:
The primary objective of this Phase 3 study is to evaluate the impact of NAC 1200 mg versus matched placebo (PBO) twice daily, added to contingency management (CM), on cannabis use among treatment-seeking cannabis-dependent adults (ages 18-50). After assessment and inclusion into the study, participants will be randomized to receive a 12-week course of NAC 1200 mg or matched placebo twice daily. All participants will concurrently participate in a twice-weekly contingency management (CM) intervention. Medication management will be conducted weekly throughout treatment by the medical clinician. Urine cannabinoid testing will occur at all visits, and will be used as the primary determinant of cannabis use. Participants will return approximately four weeks after treatment conclusion for evaluation of adverse events with medication discontinuation and sustained treatment effects.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U10DA013727 | NIH | None | https://reporter.nih.gov/quic… | View |
| UG1DA013727 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10DA013045 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10DA015815 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10DA013732 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10DA015831 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10DA020024 | NIH | None | https://reporter.nih.gov/quic… | View |