Tobacco Use Disorder Clinical Trial
Official title:
Evaluating the Efficacy of Cannabidiol for Reducing Cigarette Use
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. We 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 reduction of cigarette use. The primary endpoint will be reduction in cigarette use, indexed by self-reported cigarettes/day and plasma cotinine. The secondary endpoint will be abstinence from smoking, indexed categorically by self-report and confirmed biochemically by expired carbon monoxide (CO) during the last 2 weeks of the trial. 2. Evaluate CBD effects on participant retention. The primary endpoint will be retention in the trial, indicated by number of days that participants continue in the trial. Secondary endpoints will be nicotine dependence and withdrawal (measured weekly on the Fagerström Test for Nicotine Dependence and Minnesota Withdrawal Scale, respectively), and mood states (measured weekly on the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 screener). 3. Exploratory Aims. Measure CBD and endocannabinoids. Plasma concentrations of CBD, N-arachidonoyl-ethanolamine (anandamide) and 2-arachidonoylglycerol (2-AG), will be measured at baseline and at specified times throughout the trial. The primary endpoint will be CBD plasma level. 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.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: We will study equal numbers of males and females, 18 - 65 years of age, who smoke cigarettes and are in residential treatment for substance use disorders. Recruitment will be from participants at Cri-Help Treatment Center in North Hollywood, CA. 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. We will include all racial and ethnic groups. Based on the population of the surrounding communities in the Los Angeles region, we 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. Smoking cigarettes and at least moderate nicotine dependence, as indicated by a score of at least 4 on the Fagerström Test for Nicotine Dependence (Heatherton et al., 1991) are inclusion criteria. Although vaping is popular and a high proportion of participants who vape also report cigarette smoking (58%) (Smith et al., 2022), we will exclude participants who vape nicotine. Vaping is not allowed at Cri-Help, Inc. - Exclusion Criteria: - 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 (Welty et al., 2014). Opioid drugs metabolized by cytochrome P450 (CYP450), and cytochrome P450 isoenzyme CYP3A4 (CYP3A4) in particular, include fentanyl, methadone, oxycodone, and buprenorphine (Kotlinska Lemieszek et al., 2015). - 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). - Clinically significant cardiovascular, hematologic, hepatic, renal, neurological, or endocrine abnormalities [specific exclusion criteria: AST greater than or equal to 3Xs ULN, Bilirubin greater or equal to 1.5 X ULN, Prothrombin time/International Normalized Ratio (INR) > 1.5. - 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", we 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. |
Country | Name | City | State |
---|---|---|---|
United States | CRI-Help, Inc. | North Hollywood | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Plasma concentrations of CBD | The primary endpoint will be CBD plasma level (ng/mL) which will be measured at baseline and regularly throughout the trial. | 24 weeks | |
Other | Plasma concentrations of N-arachidonoyl ethanolamine (anandamide) | Anandamide (ng/mL) will be measured at baseline and regularly throughout the trial. | 24 weeks | |
Other | Plasma concentrations of 2-arachidonoylglycerol (2-AG) | Levels of 2-AG 9ng/mL) will be measured at baseline and regularly throughout the trial. | 24 weeks | |
Primary | Evaluate the effects of CBD on reduction of cigarette use | Reduction in cigarette use will be indexed by self-reported number of cigarettes/day. | 24 weeks | |
Primary | Validate self-reported effects of CBD on reduction of cigarette use | Plasma levels of cotinine (ng/mL) will be measured to validate self-reported tobacco use. | 24 weeks | |
Primary | Evaluate CBD effects on participant retention | The primary endpoint will be retention in the trial, indicated by number of days that participants continue in the protocol. | 8 weeks | |
Secondary | Abstinence from smoking during the last 2 weeks of the trial | Abstinence from smoking will be indexed categorically by self-report questionnaires. | 2 weeks (Days 42-56) | |
Secondary | Confirmation of abstinence from smoking during the last 2 weeks of the trial | Self-reported abstinence will be confirmed by point of care measurement of expired carbon monoxide (CO, parts per million, ppm). | 2 weeks (Days 42-56) | |
Secondary | Validation of abstinence from smoking during the last 2 weeks of the trial | Abstinence from smoking during the last 2 weeks of the trial will be confirmed biochemically by measure of plasma cotinine (ng/mL). | 2 weeks (Days 42-56) | |
Secondary | Change in nicotine dependence | Nicotine dependence will be measured weekly on the Fagerström Test for Nicotine Dependence. It contains six items.
Yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. |
8 weeks | |
Secondary | Change in nicotine withdrawal | Nicotine withdrawal will be measured weekly measured weekly on the Minnesota Withdrawal Scale (MNWS; Hughes & Hatsukami, 1986), which measures cigarette craving, irritability, anxiety, difficulty concentrating, restlessness, headache, drowsiness, and gastrointestinal tract disturbances. These symptoms are generally scored on an ordinal scale ranging from 0 (not present) to 3 (severe intensity). A summary score is computed. | 8 weeks |
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