Phase
Condition
Tobacco Use Disorder
Treatment
600 mg Cannabidiol
300 mg Cannabidiol
Placebo
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have provided written informed consent
Be between the ages of 18 and 65
Report use of > 10 cigarettes per day for > 1 year with smoking status verified byeither a positive breath carbon monoxide test (>8ppm) or urine cotinine test (>200ng/mL) at screening
Report interest in quitting tobacco in the next two months
Are willing to engage in a series of practice quit attempts as part of the study.
Be in good general health based on a physical examination, medical history, vitalsigns, and screening urine and blood tests as determined by a licensed medicalprofessional.
For women of children bearing potential and men with female partners ofchild-bearing potential, must be willing to use an effective form of contraceptionduring the study and for at least 30 days after the last study drug administration.Acceptable forms of contraception include: double barrier contraception or acombination of a barrier contraception and a hormonal implant, injectable, combinedoral contraceptive, or a male partner who has had a vasectomy; intrauterine deviceor tubal ligation.
Exclusion
Exclusion Criteria:
Meet Diagnostic and Statistical Manual-V criteria for substance use disorders exceptfor nicotine or tobacco use disorders
Are currently receiving or interested in immediately receiving behavioral treatmentor medication for smoking cessation
Test positive for drugs of abuse (except nicotine) and/or breath alcohol test atstudy admission
Have a current physical or mental illness judged by the study team to negativelyimpact participant safety or scientific integrity.
Have a lifetime history of suicidal behavior (i.e. past suicide attempt), or currentsuicidal behavior or ideation as assessed by the Columbia Suicide Severity RatingScale (C-SSRS)
Are currently pregnant, planning to become pregnant in the next three months or arecurrently breastfeeding.
Use of an over the counter, systemic or topical drug(s), herbal supplement(s), orvitamin(s) within 14 days (or 5 half-lives for that specific drug) of experimentalsessions; which, in the opinion of the investigator or sponsor, will interfere withthe study results or the safety of the participant
Use of a prescription medication (with the exception of birth control prescriptions)within 14 days (or 5 half-lives for that specific drug) of experimental sessions;which, in the opinion of the investigator or sponsor, will interfere with the studyresult or the safety of the participant. This includes any medication metabolizedvia CYP2D6, CYP2C9, CYP2B10, or which induce/inhibit CYP3A4 enzymes.
Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g. Prinzmetal's angina).
Have elevated serum liver transaminase (AST or ALT) above 2 x upper limit of normal,or elevated bilirubin above 1.5 x upper limit of normal.
Are currently enrolled in another clinical trial or have received any drug as partof a research study within 30 days of study participation.
Study Design
Study Description
Connect with a study center
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland 21224
United StatesSite Not Available
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore 4347778, Maryland 4361885 21224
United StatesActive - Recruiting

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