Clinical Trial

Longitudinal Outpatient Treatment for Cannabis Use Disorder

Study acronym: LOTUS
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This study is a placebo-controlled randomized trial comparing the effects of hemp-derived cannabidiol (CBD) with and without Delta-9-tetrahydrocannabinol (THC), relative to placebo, on reducing cannabis use and cannabis use disorder (CUD) symptoms in adult treatment seeking cannabis concentrate users with CUD. Participants enroll in the study for 8 weeks (with telehealth follow-ups at 12 and 16 weeks) and are randomized to either full spectrum CBD, broad spectrum CBD, or placebo. Participants are also engaged in five weeks of psychotherapy treatment for CUD. Blood is collected to quantify investigational drug exposure and cannabis use. Participants also complete self-report measures of medical history, sleep quality, subjective cognitive function, physical activity, psychological functioning, substance use, and acute drug effects.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-10-23; most recent amendment 2026-06-10.
Status change: Not Yet Recruiting → Recruiting 2024-05-17
Trial Details
NCT Number NCT06107062
Lead Sponsor University of Colorado, Boulder
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Cannabis Use Disorder
Enrollment 165 participants
Start Date 2024-07-26
Primary Completion 2028-03-31 (estimated)
Study Completion 2029-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-12