Clinical trial NCT03681353: Impact of Reduced Cannabis Use on Functional Outcomes
Official title: Impact of Reduced Cannabis Use on Functional Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis
Cannabis Use
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* cannabis use on ≥40 of past 90 days
* ability to speak and write fluent English
* 18-70 years of age
* willingness to attempt to temporarily reduce cannabis use

Exclusion Criteria:

* expect to have an unstable medication regimen during the study
* are currently receiving non-study CUD treatment
* meet criteria for serious mental illness (e.g., bipolar disorder, schizophrenia)
* become imprisoned
* become hospitalized for psychiatric reasons
* become pregnant
* report imminent risk for suicide or homicide
* meet criteria for a substance use disorder other than CUD or tobacco

Primary outcomes:
measure: Number of Participants Who Complete the Baseline Assessment
timeFrame: Baseline
measure: Number of Participants Who Complete the 8-week Follow-up Assessment
timeFrame: 8- week follow up
measure: Number of Participants Who Complete 1 or More Ecological Momentary Assessments (EMA) Per Day (Total ≥56) for the Duration of the 8-week EMA Protocol
timeFrame: 8 week follow up
measure: Number of Participants Who Score Above Threshold on Treatment Acceptability Measure
timeFrame: 8-week posttreatment visit
Secondary outcomes:
measure: Number of Participants Who Have ≥ 50% Reduction in Frequency of Cannabis Use
timeFrame: Ad lib monitoring period (up to 2 weeks), 8-week posttreatment visit
measure: Average Number of Days Since Last Cannabis Use
timeFrame: 8-week posttreatment visit
measure: Number of Participants Who Have ≥ 50% Reduction in Quantity of Cannabis Use
timeFrame: Ad lib monitoring period (up to 2 weeks), 8-week posttreatment visit
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References: