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Longitudinal Outpatient Treatment for Cannabis Use Disorder

Study acronym: LOTUS
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date: May 16, 2024 to Jul 26, 2024v7
  2. Re-verified, no change to tracked fieldsv6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 15, 2024 to May 16, 2024
    v5
  4. Start date: Mar 1, 2024 to May 15, 2024v4
  5. Study description expanded, about 2 wordsv3
  6. Primary endpoints: 5 to 4
    • Interventions: Cannabidiol (Drug), Placebo (Drug) to Cannabidiol - bsCBD (Drug), Cannabidiol - fsCBD (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: 3 to 5
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06107062
Lead Sponsor University of Colorado, Boulder
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions
(from sponsor)		 Cannabis Use Disorder
Enrollment 165 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov