Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04567238
Status:
COMPLETED
Last Update Posted:
2023-12-11
First Post:
2020-09-23
Brief Title:
Impact of Reduced Cannabis Use on Functional Outcomes R33 Phase
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Impact of Reduced Cannabis Use on Functional Outcomes R33 Phase
Status:
COMPLETED
Status Verified Date:
2023-12
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:
FOCUS
Brief Summary:
Nearly 20 million Americans report use of cannabis in the past month and heavy cannabis use has increased by nearly 60 in the US since 2007 Heavy cannabis use is associated with lower educational attainment reduced physical activity increased rates of addiction and unemployment and neuropsychological deficits Studies suggest that cannabis use is also associated with increased mental health symptoms drugged driving and traffic accidents While there is evidence that sustained abstinence can lead to improvements in the functional outcomes of former users the degree to which reductions alone ie not sustained abstinence in cannabis use might be associated with positive changes in functional outcomes is unknown This is a critical gap in the literature as many interventions for cannabis and other drugs are associated with decreases in frequency and quantity of use but fail to achieve an effect on overall abstinence rates The objective of the present research is to use ecological momentary assessment EMA a real-time naturalistic data collection method to prospectively study the impact of reduced cannabis use on functional outcomes in heavy cannabis users Contingency management CM will be used to promote reductions in frequency and quantity of cannabis use CM is an intensive behavioral therapy that is highly effective at producing short-term reductions in illicit drug use We have recently developed a novel approach that leverages mobile technology and recent developments in cannabis testing We have pilot-tested this approach with heavy cannabis users and found that it is an acceptable and feasible method The present research will use this technology in conjunction with EMA methods to study the impact of reduced cannabis use on key functional outcomes Our central hypothesis is that reductions in frequency and quantity of cannabis use will lead to positive changes in cannabis users mental health self-efficacy physical activity working memory health-related quality of life and driving behavior The rationale for this research is that it will provide the first and only real-time data concerning the potential impact of reductions in cannabis use on functional outcomes As such the findings from the present research will directly inform ongoing efforts to include reductions in illicit drug use as a valid clinically-meaningful outcome measure in clinical trials of pharmacotherapies for the treatment of substance use disorders
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None