Longitudinal Outpatient Treatment for Cannabis Use Disorder

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.

Timeline

Start

2024-07-26

Primary completion

2028-03-31

Completion

2029-03-31

Publications

• Bidwell LC, Martin-Willett R, Melendez SN, Rosa L, Giordano G, Hutchison KE, Bryan AD. LOTUS: Protocol for a double-blind placebo controlled randomized trial of hemp-derived cannabidiol for the treatment of cannabis use disorder. PLoS One. 2024 Sep 30;19(9):e0308262. doi: 10.1371/journal.pone.0308262. eCollection 2024.

Drugs

Indications