Cannabis dependence (Cannabis Use Disorder or CUD)
Conditions
Brief summary
Reduction in total cannabis intake (grams) over the last 28 days, measured using the TLFB after 20 weeks of treatment and adjusted for baseline.
Detailed description
Change in plasma and urine concentrations of Δ9-THC and its metabolites (including THC-COOH) from baseline to week 20., Change in Cannabis-free days over the past 28 days, assessed using self-reported TLFB From baseline to week 20., Change in total THC consumption, measured in standard THC units over the past 28 days and assessed using the Enhanced Cannabis Timeline Follow-Back (EC-TLFB), adjusted for baseline, from baseline to Week 20. (Total THC consumption is calculated based on grams used, method of administration, and average THC concentration from seized cannabis in Denmark.), Change in Cannabis Use Disorder Identification Test – Revised (CUDIT-R) score from baseline to Week 20., Change in Marijuana Problem Scale (MPS) score from baseline to Week 20., Change in Marijuana Craving Questionnaire – Short Form (MCQ-SF) score from baseline to Week 20., Change in Patient Health Questionnaire-9 (PHQ-9) score from baseline to Week 20., Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline to Week 20., Change in Alcohol Use Disorders Identification Test (AUDIT) score from baseline to Week 20., Change in Drug Use Disorders Identification Test (DUDIT/DUDIT-ED) score from baseline to Week 20., Change in Fagerström Test for Nicotine Dependence score from baseline to Week 20., Change in mean number of cigarettes smoked per day, averaged over the past week, from baseline to Week 20., Change in World Health Organization Quality of Life – BREF (WHOQOL-BREF) score from baseline to Week 20., Percent change in body weight from baseline to Week 20., Change in waist circumference (cm) from baseline to Week 20., Change in blood cotinine levels from baseline to Week 20., Change in blood pressure and pulse from baseline to Week 20., Change in HbA1c from baseline to Week 20., Change in fMRI cue reactivity, assessed using the task described by Karoly et al., from baseline to Week 20., Change in resting-state fMRI connectivity from baseline to Week 20.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in total cannabis intake (grams) over the last 28 days, measured using the TLFB after 20 weeks of treatment and adjusted for baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in plasma and urine concentrations of Δ9-THC and its metabolites (including THC-COOH) from baseline to week 20., Change in Cannabis-free days over the past 28 days, assessed using self-reported TLFB From baseline to week 20., Change in total THC consumption, measured in standard THC units over the past 28 days and assessed using the Enhanced Cannabis Timeline Follow-Back (EC-TLFB), adjusted for baseline, from baseline to Week 20. (Total THC consumption is calculated based on grams used, method of administration, and average THC concentration from seized cannabis in Denmark.), Change in Cannabis Use Disorder Identification Test – Revised (CUDIT-R) score from baseline to Week 20., Change in Marijuana Problem Scale (MPS) score from baseline to Week 20., Change in Marijuana Craving Questionnaire – Short Form (MCQ-SF) score from baseline to Week 20., Change in Patient Health Questionnaire-9 (PHQ-9) score from baseline to Week 20., Change in Pittsburgh Sleep Quality Index (PSQI) score | — |