Cannabidiol for Reducing Cigarette Use
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, Los Angeles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Cannabidiol (CBD) 800 mg
DrugCBD (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
DrugThe 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Cannabidiol (CBD) 800 mgActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the effects of CBD on nicotine intake
Nicotine intake will be determined by levels of plasma cotinine (ng/mL).
Time frame
8 weeksSecondary outcomes
1
Abstinence from smoking during the last 2 weeks of the trial
Abstinence from smoking will be indexed categorically by self-report questionnaires.
Time frame
2 weeks (Days 42-56)2
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).
Time frame
2 weeks (Days 42-56)3
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.
Time frame
24 weeks4
Nicotine withdrawal
Nicotine withdrawal will be measured weekly measured weekly on the Minnesota Withdrawal Scale, 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.
Time frame
24 weeksOther outcomes
1
Plasma concentrations of CBD
Plasma levels of CBD (ng/mL) will be measured at baseline and day 7.
Time frame
1 week2
Plasma concentrations of N-arachidonoyl ethanolamine (anandamide)
Plasma levels of anandamide (ng/mL) will be measured at baseline and day 7.
Time frame
1 week3
Plasma concentrations of 2-arachidonoylglycerol (2-AG)
Plasma levels of 2-AG (ng/mL) will be measured at baseline and day 7.
Time frame
1 weekSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
Center For Medicinal Cannabis Research at UC San Diego Health
Collaborator
Source ClinicalTrials.gov