Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-25 @ 2:53 PM
Study NCT ID:
NCT00542750
Status:
COMPLETED
Last Update Posted:
2018-05-23
First Post:
2007-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents
Sponsor:
Medical University of South Carolina
Organization:
Study Overview
Official Title:
An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents
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:
NAC MJ Pilot
Brief Summary:
The purpose of this pilot study is to determine the feasibility of conducting a trial of N-Acetylcysteine in cannabis dependent adolescents.
Detailed Description:
This project involves investigation of oral N-acetylcysteine (NAC) as a potential pharmacologic agent for treatment of cannabis dependence in adolescents. Cannabis dependence continues to be a major problem among adolescents in the United States. To date, psychosocial interventions have produced only small to modest effect sizes in controlled trials, and minimal work has been done to investigate the potential role for pharmacotherapy for cannabis dependence. Translating preclinical research suggesting a role for NAC in cocaine dependent individuals, our research group has developed preliminary evidence of decreased cocaine use and cue reactivity in humans taking NAC. Preclinical research has additionally demonstrated significant parallels in glutamatergic dysfunction in the nucleus accumbens (the proposed target of NAC treatment) between habitual cocaine and marijuana users. NAC is an inexpensive, long-available agent with a favorable tolerability profile in adults and children. However, it has not yet been studied in cannabis dependent adolescents. Hence, we are undertaking an open-label pilot trial of NAC in adolescents with cannabis dependence.
The primary specific aims of the proposed project are:
1. To assess the feasibility of conducting a trial of NAC in cannabis dependent adolescents.
2. To assess the safety and tolerability of NAC in cannabis dependent adolescents
The secondary specific aim of the proposed project is:
3. To gather variability information to assist in design of a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents.
Primary hypotheses
1. It will be feasible to recruit and retain cannabis dependent adolescents in a trial of NAC.
2. NAC will be well tolerated among cannabis dependent adolescents.
Secondary hypothesis
3. Adequate variability information will be gathered to design a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents.
Twenty-four adolescents between 12 and 20 years old will be recruited in this study. Results from this project will be used to design further studies.
The primary specific aims of the proposed project are:
1. To assess the feasibility of conducting a trial of NAC in cannabis dependent adolescents.
2. To assess the safety and tolerability of NAC in cannabis dependent adolescents
The secondary specific aim of the proposed project is:
3. To gather variability information to assist in design of a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents.
Primary hypotheses
1. It will be feasible to recruit and retain cannabis dependent adolescents in a trial of NAC.
2. NAC will be well tolerated among cannabis dependent adolescents.
Secondary hypothesis
3. Adequate variability information will be gathered to design a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents.
Twenty-four adolescents between 12 and 20 years old will be recruited in this study. Results from this project will be used to design further studies.
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 |
|---|---|---|---|---|
| K12DA000357 | NIH | None | https://reporter.nih.gov/quic… | View |