Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03681353 |
| Other study ID # |
Pro00100100 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 4, 2019 |
| Est. completion date |
September 23, 2020 |
Study information
| Verified date |
March 2021 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Nearly 20 million Americans report use of cannabis in the past month, and heavy cannabis use
has increased by nearly 60% in the U.S. since 2007. Heavy cannabis use is associated with
lower educational attainment, reduced physical activity, and increased rates of addiction,
unemployment, and neuropsychological deficits. Studies by the lab and others suggest that
cannabis use is also associated with increased mental health symptoms and suicidal and
nonsuicidal self-injury. In addition, cannabis is the illicit drug most strongly associated
with drugged driving and traffic accidents, including fatal accidents. There is evidence that
sustained abstinence from cannabis can lead to improvements in the functional outcomes of
former users. However, he degree to which reductions in cannabis use might be associated with
positive changes in functional outcomes is currently unknown. The overall objective of the
present research is to use ecological momentary assessment (EMA), a real-time, naturalistic
data collection method, to 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. The investigators novel
approach includes mobile technology to make CM more portable and feasible. The present
research will use this technology in conjunction with state-of-the-art EMA methods to study
the impact of reduced cannabis use on key functional outcomes. The investigators central
hypothesis is that reductions in frequency and quantity of cannabis use will lead to positive
changes in cannabis users' mental health, physical activity, working memory, health-related
quality of life, and driving behavior.
Description:
Nearly 20 million Americans report use of cannabis in the past month, and heavy cannabis use
has increased by nearly 60% in the U.S. since 2007. Heavy cannabis use is associated with
lower educational attainment, reduced physical activity, and increased rates of addiction,
unemployment, and neuropsychological deficits. Studies by the lab and others suggest that
cannabis use is also associated with increased mental health symptoms and suicidal and
nonsuicidal self-injury. In addition, cannabis is the illicit drug most strongly associated
with drugged driving and traffic accidents, including fatal accidents. While there is
evidence that sustained abstinence can lead to improvements in the functional outcomes of
former users, the degree to which reductions in cannabis use alone (i.e., in the absence of
sustained abstinence) might be associated with positive changes in functional outcomes is
currently unknown. This is a critical gap in the literature, as many clinical 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 overall 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. EMA addresses several limitations of traditional
assessment techniques by enhancing ecological validity, minimizing memory bias, and enabling
examination of the impact of context on participants' behavior. 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. Moreover, the investigators have recently developed a novel approach that
leverages mobile technology and recent developments in cannabis testing to make CM for
cannabis more portable and feasible. The investigators have pilot-tested this approach with
heavy cannabis users and found that it is an acceptable and feasible method to reduce their
cannabis use. The present research will use this technology in conjunction with
state-of-the-art EMA methods to study the impact of reduced cannabis use on key functional
outcomes. The investigators central hypothesis is that reductions in frequency and quantity
of cannabis use will lead to positive changes in cannabis users' mental health, 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.
