Cannabidiol for Reducing Cigarette Use

NCT06218056 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 23-0017931153042
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Evaluate the effects of CBD on nicotine intake.
2. 2.Exploratory Aims. Measure plasma concentrations of CBD, N-arachidonoyl-ethanolamine (anandamide) and 2-arachidonoylglycerol (2-AG) at baseline and day 7.

Conditions

Tobacco Use Disorder; Tobacco Smoking; Tobacco Dependence

Keywords

Cannabidiol; Tobacco Use Disorder; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Evaluate the effects of CBD on nicotine intake

  Nicotine intake will be determined by levels of plasma cotinine (ng/mL).

  8 weeks

Secondary Outcomes (7)

• Abstinence from smoking during the last 2 weeks of the trial

  2 weeks (Days 42-56)

• Confirmation of abstinence from smoking during the last 2 weeks of the trial

  2 weeks (Days 42-56)

• Nicotine dependence

  24 weeks

• Nicotine withdrawal

  24 weeks

• Mood state - depression

  24 weeks

Other Outcomes (3)

• Plasma concentrations of CBD

  1 week

• Plasma concentrations of N-arachidonoyl ethanolamine (anandamide)

  1 week

• Plasma concentrations of 2-arachidonoylglycerol (2-AG)

  1 week

Study Arms (2)

Cannabidiol (CBD) 800 mg

ACTIVE COMPARATOR

Sixty participants who meet all eligibility criteria will be randomized to receive CBD (ATL5; Ananda Scientific) at a dose of 800 mg.

Drug: Cannabidiol (CBD) 800 mg

Placebo

PLACEBO COMPARATOR

Sixty participants who meet all eligibility criteria will be randomized to receive placebo.

Drug: Placebo

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.

Cannabidiol (CBD) 800 mg

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The investigators will study equal numbers of males and females betweeen 18 - 65 years of age who have Tobacco Use Disorder and express a desire for smoking cessation. Participants will be recruited from the clientele base at Cri-Help Treatment Center in North Hollywood, CA, where the investigators have a long-standing relationship and where the investigators have conducted other research protocols. This study will be conducted at Cri-Help Treatment Center.
• Participants will not be recruited from the general population for this study because common use of cannabis in the greater Los Angeles area would confound measurements of CBD, interfering with evaluation of the association of plasma level from treatment with efficacy. This problem is avoided in studying participants who are receiving treatment at a facility where cannabis use is not allowed.
• The investigators will include all racial and ethnic groups. Based on the population of the surrounding communities in the Los Angeles region, the investigators anticipate a racial and ethnic makeup of approximately 26% White, 9% Black/African American, 49% Hispanic/Latino, 14% Asian American, and 2% multi-racial/unknown. These percentages align with our recent studies.

You may not qualify if:

• Physiological dependence on alcohol or any drug, requiring medical detoxification and/or showing signs of acute withdrawal symptoms from opioids, alcohol or benzodiazepines.
• Treatment of Opioid Use Disorder with buprenorphine or methadone to avoid potential drug-drug interactions. CBD interacts with CYP3A. Opioid drugs metabolized by cytochrome P450 (CYP450), and cytochrome P450 isoenzyme CYP3A4 (CYP3A4) in particular, include fentanyl, methadone, oxycodone, and buprenorphine.
• Meeting DSM-5 criteria for schizophrenia, Bipolar I disorder, psychotic disorder, having active suicidal ideation, or suicide attempt in the past 12 months. NOTE: Participants with other psychiatric conditions, such as major depression, generalized anxiety, dysthymia, social phobia or specific phobia can enroll if they are clinically stable.
• AIDS or current HIV medication treatment with antiviral and/or non-antiviral therapy (due to the interaction of CBD with antiviral therapy).
• Clinically significant abnormalities on EKG (such as evidence of arrhythmia or MI).
• Pregnancy and/or lactation. Contraception methods required at time of enrollment, and throughout the duration of the study medication period include abstinence, oral contraceptives, depot contraceptives, condom with spermicide, cervical cap with spermicide, diaphragm with spermicide, intrauterine device, surgical sterilization (e.g. tubal ligation, vasectomy).
• Because of evidence that CBD affects ovarian function in rats, women with values outside the reference ranges on a hormonal battery \[estradiol, follicle- stimulating hormone, free thyroxine index, luteinizing hormone, prolactin, total T3 and total T4, thyroid-stimulating hormone\], followed by an abnormal ovarian ultrasound finding will be excluded.
• Based on data obtained using Epidiolex® (CBD) oral solution label section 7, "Drug Interactions", the investigators will exclude participants who are taking the following medications: a) strong inducers of CYP3A4 or CYP2C19, which may decrease CBD plasma levels; and b) substrates of UGT1A9, UGT2B7, CYP2B6, CYP2C19 due to the potential of CBD to inhibit enzyme activity.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Center For Medicinal Cannabis Research at UC San Diego Health: collaborator

Study Sites (1)

CRI-Help, Inc.

North Hollywood, California, 91601, United States

RECRUITING

Related Publications (47)

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  BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Smoking; Smoking Cessation

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Edythe D London, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edythe D London, PhD

CONTACT

310-825-0606; ELondon@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor in Residence

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 23, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be provided to CMCR and CMCR leadership will decide on requests for data from other investigators -- after the study is complete, expected in December 2026.
• Access Criteria: Interested investigators would need to contact CMCR, where criteria will be determined.

Locations

US (1)