RECRUITING

Cannabidiol for Reducing Cigarette Use

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Conditions

Tobacco Use DisorderTobacco SmokingTobacco DependenceCannabidiolSmoking Cessation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 changes in cigarette use throughout and following the trial. 2. Exploratory Aims. Measure plasma concentrations of CBD, N-arachidonoyl-ethanolamine (anandamide) and 2-arachidonoylglycerol (2-AG) throughout the trial. 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.

Official Title

Evaluating the Efficacy of Cannabidiol for Reducing Cigarette Use

Quick Facts

Study Start:2024-10-31
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06218056

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Physiological dependence on alcohol or any drug, requiring medical detoxification and/or showing signs of acute withdrawal symptoms from opioids, alcohol or benzodiazepines.
  2. * 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.
  3. * 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.
  4. * AIDS or current HIV medication treatment with antiviral and/or non-antiviral therapy (due to the interaction of CBD with antiviral therapy).
  5. * Clinically significant abnormalities on EKG (such as evidence of arrhythmia or MI).
  6. * Clinically significant cardiovascular, hematologic, hepatic, renal, neurological, or endocrine abnormalities \[specific

Contacts and Locations

Study Contact

Edythe D London, PhD
CONTACT
310-825-0606
ELondon@mednet.ucla.edu

Principal Investigator

Edythe D London, PhD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

CRI-Help, Inc.
North Hollywood, California, 91601
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Edythe D London, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-31
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-10-31
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Cannabidiol
  • Tobacco Use Disorder
  • Smoking Cessation

Additional Relevant MeSH Terms

  • Tobacco Use Disorder
  • Tobacco Smoking
  • Tobacco Dependence