National Institute on Drug Abuse – Center for Technology and Behavioral Health Pilot Core
March 2016 - March 2017
Christina Brezing, MD
Other Project Staff
Frances R. Levin, MD (Mentor); Edward V. Nunes, MD (Mentor)
Cannabis is the most widely used illicit drug in the United States. Social and policy trends, as reflected in national surveys and state legislation, demonstrate increasing acceptance and use of cannabis with decreasing perception of harm which will likely result in an increased occurrence of cannabis use disorder. There are no FDA approved medications for the treatment of cannabis use disorder, and few individuals who receive behavioral interventions are able to achieve sustained abstinence. Additionally, treatment trials for cannabis use disorder focus predominantly on outcome measures that only provide information regarding changes in amount and frequency of cannabis used. While these measures are currently the gold standard for assessing change in cannabis use disorder trials and serve a very useful function, they do not provide additional information about an individual’s health and well-being. There has been recent interest in determining whether reductions in illicit drug use are associated with positive changes in health-related and other functional outcomes in individuals with substance use disorders, like cannabis use disorder. Incorporating both subjective and objective measures to capture positive-health changes in a cannabis use disorder treatment trial is very valuable in providing a more complete picture of changes that occur in this setting. Mobile health sensors have the potential to serve the function of objectively measuring health outcomes and health-related behaviors in conjunction with subjective measures. To date, there are no published studies utilizing a mobile health sensor in a clinical treatment trial for cannabis use disorder.
This pilot study will incorporate a mobile health sensor to collect real-time data on health-related behaviors, including activity, sleep, and stress, before, during, and after an eight-week, open label, medication treatment trial, using lorcaserin (a 5HT2c-receptor agonist) for cannabis use disorder. We know from previous open label trials, that variations will exist in how people respond to the medication: some will abstain, some will reduce, and some will not change their use. As individuals in this study change (or don’t change) their cannabis use, we will look at within subject mobile health sensor data and other measures, including self-report. The primary aims of this study are to determine the feasibility of incorporating a mobile health sensor device into an outpatient treatment trial for cannabis use disorder and to evaluate the effects of change in cannabis use on health related behaviors that impact quality of life and functioning. Ultimately, we see this pilot project as serving a foundational role in providing data that is relatively inexpensive, mobile, and passively collected on objective assessments of behavior that contribute to quality of life and functional status of patients as they relate to changes in cannabis use. Future studies can build upon these findings to better understand nuanced processes involved in treatment trials that may predict responses to treatment and provide insight into key opportunities to implement tailored interventions at the individual level for cannabis use disorder.