N/A
N=25
Impact of Reduced Cannabis Use on Functional Outcomes
Cannabis · Cannabis Use
Bottom Line
View on ClinicalTrials.gov: NCT03681353 ↗Enrolled (actual)
25
Serious AEs
5.6%
Results posted
Mar 2021
Primary outcome: Primary: Number of Participants Who Complete the Baseline Assessment — 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mobile Contingency Management, active (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Complete the Baseline Assessment |
18 | — |
| PRIMARY Number of Participants Who Complete the 8-week Follow-up Assessment |
18 | — |
| PRIMARY 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 |
8 | — |
| PRIMARY Number of Participants Who Score Above Threshold on Treatment Acceptability Measure |
18 | — |
| SECONDARY Number of Participants Who Have ≥ 50% Reduction in Frequency of Cannabis Use |
12 | — |
| SECONDARY Average Number of Days Since Last Cannabis Use |
6.95 | — |
| SECONDARY Number of Participants Who Have ≥ 50% Reduction in Quantity of Cannabis Use |
18 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03681353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.