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Cannabidiol for Tobacco Addiction

Phase 2
Waitlist Available
Led By Edythe D London, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Meeting DSM-5 criteria for schizophrenia, Bipolar I disorder, psychotic disorder, active suicidal ideation, or suicide attempt in the past 12 months
Taking strong inducers of CYP3A4 or CYP2C19, or substrates of UGT1A9, UGT2B7, CYP2B6, CYP2C19
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks (days 42-56)

Summary

This trial aims to determine if cannabidiol (CBD) can help people reduce their cigarette smoking. Many people struggle to quit smoking even with available treatments, so new approaches are needed. The study

Who is the study for?
This trial is for individuals seeking to quit smoking and are currently in a substance abuse treatment program. Participants must desire to stop smoking, be willing to take CBD or placebo twice daily, and complete various tests and questionnaires. They cannot use other cannabis products during the study.
What is being tested?
The study is testing whether cannabidiol (CBD) can help reduce cigarette use. Participants will receive either a placebo or CBD at doses of 400 mg or 800 mg under supervision for 56 days, with follow-up visits at one and three months after treatment ends.
What are the potential side effects?
Possible side effects from taking CBD may include changes in appetite, mood alterations, dizziness, dry mouth, nausea, fatigue, irritability or liver abnormalities. The exact side effects will be monitored through questionnaires.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with schizophrenia, bipolar I, or another psychotic disorder, or I've had thoughts of or attempted suicide in the past year.
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I am not on medication that affects certain liver enzymes.
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I am being treated for opioid addiction with buprenorphine or methadone.
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I am currently on medication for HIV/AIDS.
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My hormone tests and ovarian ultrasound were abnormal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks (days 42-56)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks (days 42-56) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate CBD effects on participant retention
Evaluate the effects of CBD on reduction of cigarette use
Validate self-reported effects of CBD on reduction of cigarette use
Secondary study objectives
Abstinence from smoking during the last 2 weeks of the trial
Change in nicotine dependence
Change in nicotine withdrawal
+2 more
Other study objectives
Plasma concentrations of 2-arachidonoylglycerol (2-AG)
Plasma concentrations of CBD
Plasma concentrations of N-arachidonoyl ethanolamine (anandamide)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Cannabidiol (CBD) 400 mg or 800 mgActive Control1 Intervention
Sixty participants who meet all eligibility criteria will be randomized to receive CBD (ATL5; Ananda Scientific) at a dose of 400 mg or 800 mg.
Group II: PlaceboPlacebo Group1 Intervention
Sixty participants who meet all eligibility criteria will be randomized to receive placebo.

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,564 Previous Clinical Trials
10,262,513 Total Patients Enrolled
9 Trials studying Tobacco Use Disorder
962 Patients Enrolled for Tobacco Use Disorder
Edythe D London, PhDPrincipal InvestigatorUniversity of California, Los Angeles
2 Previous Clinical Trials
47 Total Patients Enrolled
~80 spots leftby Dec 2026
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