Cannabidiol for Reducing Cigarette Use

Part of paid clinical trials in North Hollywood, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06218056
Phase
PHASE2
Status
Recruiting
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Conditions

  • Tobacco Dependence
  • Tobacco Smoking
  • Tobacco Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cannabidiol (CBD) 800 mg — DRUG
    CBD (400 mg) will be administered orally twice daily in the morning and again in the evening in 4 capsules each containing 100 mg of the active ingredient in the Ananda investigational new drug, ATL5. ATL5 is cannabidiol (CBD), extracted from hemp, at a 10% strength (softgel capsules with 100 mg/ml of CBD per capsule). The novel formulation is based on the principle that a water-free mixture of some concentrated inactive ingredients (excipients) self-assemble spontaneously into liquid nanodomains that contain the active component CBD. ATL5 Softgel Capsules will be manufactured by Baxco Pharmaceutical Inc., (California, USA) under cGMP conditions.
  • Placebo — DRUG
    The placebo softgel capsule formulation will have a composition with the same relative proportions as the CBD ATL5 Softgel Capsules. This formulation will be manufactured by Baxco Pharmaceutical Inc under cGMP conditions. 4 softgel capsules of placebo will be administered to match the capsule number of the active compound, daily in the morning and evening for each of 56 days.

Study Details

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.

Key Dates

Start date
Oct 31, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cannabidiol (CBD) 800 mg
    Sixty participants who meet all eligibility criteria will be randomized to receive CBD (ATL5; Ananda Scientific) at a dose of 800 mg.
  • Placebo Comparator: Placebo
    Sixty participants who meet all eligibility criteria will be randomized to receive placebo.

Primary Outcome Measure

Evaluate the effects of CBD on nicotine intake [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CRI-Help, Inc.North HollywoodCalifornia91601
Brandon Fernandez, MPH
[email protected]
818-985-8323

Find similar trials in North Hollywood, CA

By research site
CRI-Help, Inc.· North Hollywood, CA

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