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Cannabinoid

Cannabidiol for Cannabis Use Disorder (LOTUS Trial)

Phase 2
Recruiting
Research Sponsored by University of Colorado, Boulder
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks

Summary

"This trial is testing the effects of hemp-derived cannabidiol (CBD) with and without Delta-9-tetrahydrocannabinol (THC) on reducing cannabis use and cannabis use

Who is the study for?
This trial is for adults who regularly use cannabis concentrates (at least 4 times a week) for the past year, have at least moderate Cannabis Use Disorder according to DSM5, and are looking to reduce or stop their cannabis use.
What is being tested?
The study compares hemp-derived CBD with THC (fsCBD), without THC (bsCBD), and placebo in reducing cannabis use and symptoms of CUD. Participants will also receive five weeks of psychotherapy and undergo various assessments over an 8-week period with follow-ups.
What are the potential side effects?
Potential side effects may include changes in appetite, mood alterations, fatigue, gastrointestinal discomfort, and possible interactions with other medications. Effects vary by individual.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in symptoms of cannabis use disorder (CUD)
Difference in withdrawal symptoms
Secondary study objectives
Difference in alcohol use
Difference in cannabis use
Difference in emotional states
+1 more
Other study objectives
Moderators of designated outcomes

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 400mg Full Spectrum Cannabidiol (fsCBD)Experimental Treatment1 Intervention
Group II: 400mg Broad Spectrum Cannabidiol (bsCBD)Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,582 Previous Clinical Trials
3,326,875 Total Patients Enrolled
University of Colorado, BoulderLead Sponsor
124 Previous Clinical Trials
29,357 Total Patients Enrolled
~110 spots leftby Mar 2028
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