Overview of Cannabis Use Outcomes in Clinical Trials
This overview discusses secondary outcome domains related to cannabis use in clinical trials, including withdrawal symptoms, craving, mood, psychosocial functioning, dependence, readiness to change, alcohol and drug use, and quality of life. Various trials and measures for assessing cannabis withdrawal and craving are highlighted.
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Presentation Transcript
Overview of Secondary Outcome Domains ACTTION Cannabis Use Outcomes for Clinical Trials (CUOCT) Erica N. Peters March 23, 2018
Secondary Outcome Domains Cannabis withdrawal Cannabis craving Others Cannabis dependence Mood Psychosocial Functioning Cannabis-related problems Readiness to change/self-efficacy Alcohol and other drug use Quality of life March 23, 2018
Cannabis Withdrawal SYMPTOMS Sleep disturbance Irritability Anxiety Decreased appetite/weight loss Restlessness Other physical symptoms that elicit significant discomfort (i.e. abdominal pain, shakiness/tremors, sweating, fever, chills, headache) Depressed mood March 23, 2018
Cannabis Withdrawal: 9 trials Measure # of Trials 6 2 1 Marijuana Withdrawal Checklist Cannabis Withdrawal Scale Clinical Institute Withdrawal Assessment Scale Withdrawal-Related Sleep Disturbance Pittsburgh Sleep Quality Index St. Mary s Hospital Sleep Questionnaire Combination of sleep diaries and actigraphy 4 Withdrawal-Related Irritability Snaith Irritability Scale Irritability items from the Hopkins Symptom Checklist 2 March 23, 2018
Example of Cannabis Withdrawal: MWC Mason et al., 2012 March 23, 2018
Example of Cannabis Withdrawal Scale: CWS Johnston et al., 2014 March 23, 2018
Cannabis Craving 8 trials assessed cannabis craving as an outcome domain Measures Marijuana Craving Questionnaire: 7 trials Visual analog scale that assessed intensity and desire to use cannabis: 1 trial Single-item measure of craving included in the MWC: 1 trial March 23, 2018
Marijuana Craving Questionnaire March 23, 2018
Other Secondary Outcomes Outcome # of Trials 21 20 17 15 11 8 4 Cannabis dependence Mood Psychosocial functioning Cannabis-related problems Readiness to change/self-efficacy Alcohol and other drug use Quality of life March 23, 2018
Other Secondary Outcomes Outcome # of Different Instruments 10 8 17 3 7 2 5 Cannabis dependence Mood Psychosocial functioning Cannabis-related problems Readiness to change/self-efficacy Alcohol and other drug use Quality of life March 23, 2018
Conclusions Agreement on secondary outcome domains, but no clear consensus on the optimal instrument for assessing outcomes in each domain. Heterogeneity dependent on target population associated problems, and aims of trial March 23, 2018
Future Directions Which secondary outcome domains are of broad interest for assessment in CUD treatment trials? What core assessments should be used across trials for each secondary outcome domain? validated gold standard assessments short freely available relevant across cultures and translated into multiple languages PhenX Toolkit Which assessments should be used for special populations? March 23, 2018
