Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06218056 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Cannabidiol for Reducing Cigarette Use

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: 2 to 1
    • Secondary endpoints revised (7)
    • Study description expanded, about 27 words
    • Collaborators expanded, about 10 words
    v5
  2. Primary endpoints revised (2)
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: 5 to 7
    • Study description shortened, about 2,908 words
    v4
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 6 more changesShow less
    • Start date changed from estimate of Jul 15, 2024 to Oct 31, 2024
    • Primary endpoints: 3 to 2
    • Interventions: Cannabidiol (CBD) 400 mg or 800 mg (Drug), Placebo (Drug) to Cannabidiol (CBD) 800 mg (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 7 words
    • Study description expanded, about 2,897 words
    • Site details revised
  4. Start date: Feb 15, 2024 to Jul 15, 2024v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this research is to evaluate the efficacy of cannabidiol (CBD) in reducing cigarette smoking. Although there are safe and effective treatments for smoking cessation, not everyone who attempts smoking cessation is successful, even with these treatments. Relapse rates are high, leaving a need for new approaches. Despite justification to evaluate CBD for this indication, human research on the topic is scant. Larger, more extended studies are warranted and essential. The investigators will recruit participants from CRI-Help, Inc., a substance abuse treatment program in North Hollywood, where residents who indicate the desire to stop smoking are prohibited from using other cannabis products which would affect recruitment. The aims of this study are: 1. Evaluate the effects of CBD on nicotine intake. 2. Exploratory Aims. Measure plasma concentrations of CBD, N-arachidonoyl-ethanolamine (anandamide) and 2-arachidonoylglycerol (2-AG) at baseline and day 7. Participants who meet eligibility criteria will take part in a 56-day treatment phase during which they receive the study medication under supervision (CBD or placebo twice daily) and complete questionnaires on side effects, withdrawal, craving and mood symptoms. Blood, breath, and urine tests will also be performed throughout the study. Participants who complete the treatment will also be assessed at 1-month and 3-month follow up visits.
Trial Details
NCT Number NCT06218056
Lead Sponsor University of California, Los Angeles
Collaborators: Center For Medicinal Cannabis Research at UC San Diego Health
Conditions
(from sponsor)		 Tobacco Use Disorder, Tobacco Smoking, Tobacco Dependence
Related terms Smoking Cessation, Tobacco Smoking, Tobacco Use Disorder
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov