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Oral Cannabidiol for Tobacco Cessation

Primary Purpose

Tobacco Use, Tobacco Smoking, Tobacco Dependence

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
300 mg Cannabidiol
600 mg Cannabidiol
Placebo
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tobacco Use focused on measuring Tobacco, Smoking, Cannabidiol, CBD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Have provided written informed consent
  2. Be between the ages of 18 and 65
  3. Report use of > 10 cigarettes per day for > 1 year with smoking status verified by either a positive breath carbon monoxide test (>8ppm) or urine cotinine test (>200ng/mL) at screening
  4. Report interest in quitting tobacco in the next two months
  5. Are willing to engage in a series of practice quit attempts as part of the study.
  6. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests as determined by a licensed medical professional.
  7. For women of children bearing potential and men with female partners of child-bearing potential, must be willing to use an effective form of contraception during the study and for at least 30 days after the last study drug administration. Acceptable forms of contraception include: double barrier contraception or a combination of a barrier contraception and a hormonal implant, injectable, combined oral contraceptive, or a male partner who has had a vasectomy; intrauterine device or tubal ligation.

Exclusion Criteria:

  1. Meet Diagnostic and Statistical Manual-V criteria for substance use disorders except for nicotine or tobacco use disorders
  2. Are currently receiving or interested in immediately receiving behavioral treatment or medication for smoking cessation
  3. Test positive for drugs of abuse (except nicotine) and/or breath alcohol test at study admission
  4. Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity.
  5. Have a lifetime history of suicidal behavior (i.e. past suicide attempt), or current suicidal behavior or ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
  6. Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding.
  7. Use of an over the counter, systemic or topical drug(s), herbal supplement(s), or vitamin(s) 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 study results or the safety of the participant
  8. 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 study result or the safety of the participant. This includes any medication metabolized via CYP2D6, CYP2C9, CYP2B10, or which induce/inhibit CYP3A4 enzymes.
  9. Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g. Prinzmetal's angina).
  10. 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.
  11. Are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.

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Sites / Locations

  • Johns Hopkins Behavioral Pharmacology Research UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Within-Subjects Dose Conditions

Additional Within-Subjects Dose Conditions

Arm Description

All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be counterbalanced across participants. Thus, comparisons of the drug conditions on outcome measures will be compared within-subjects (e.g., between drug and placebo) and not between arms.

All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be counterbalanced across participants. Thus, comparisons of the drug conditions on outcome measures will be compared within-subjects (e.g., between drug and placebo) and not between arms.

Outcomes

Primary Outcome Measures

biochemically-verified tobacco abstinence as assessed by expired carbon monoxide
Biochemically-verified tobacco abstinence as assessed by expired carbon monoxide part per million during the 4-day practice quit attempt of each drug condition.

Secondary Outcome Measures

Smoking Puff Topography
smoking puff topography will be collected each Monday during simulated quit attempt weeks (2, 4, and 6).
Cigarette Purchase Task
Cigarette Purchase Task will be collected each Monday during simulated quit attempt weeks (2, 4, and 6).
Modified Cigarette Evaluation Scale
Modified Cigarette Evaluation Scale will be collected each Monday during simulated quit attempt weeks (2, 4, and 6).
Tobacco Smoking as assessed by self report
Self-reported cigarettes per day
Tobacco Withdrawal as assessed by the Minnesota Nicotine Withdrawal Scale
Minnesota Nicotine Withdrawal Scale Total Score (range 0 - 36) higher scores equate with greater withdrawal
Tobacco Withdrawal as assessed by the Questionnaire of Smoking Urges - Brief
Questionnaire of Smoking Urges - Brief - Ten item questionnaire contains two 5-item factor scores - higher scores equate with greater smoking urge
Tobacco Withdrawal as assessed by the Positive and Negative Affect Scale
Positive and Negative Affect Scale - composed of 20 items, 10 measuring positive affect and 10 measuring negative affect. Scores range from 1 to 5 corresponding with extent to which the affect was experienced in the specified timeframe.
Tobacco Withdrawal as assessed by the Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale - 14 item assessment of anxiety and depression. Each item measured on a 4-point scale. Higher scores equate with greater depression/anxiety.

Full Information

First Posted
June 30, 2022
Last Updated
August 7, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05445804
Brief Title
Oral Cannabidiol for Tobacco Cessation
Official Title
Oral Cannabidiol for Tobacco Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cannabidiol is a compound found in cannabis plants that is well tolerated, has low abuse liability, and might be an effective medication to promote tobacco cessation. This clinical study will use a validated approach for screening tobacco cessation medications to determine if oral cannabidiol increases short-term tobacco abstinence, and evaluate mechanisms that might explain how cannabidiol alters smoking behavior. Results from this study will provide data on the therapeutic potential of cannabidiol for tobacco cessation.
Detailed Description
Although tobacco smoking rates continue to decrease, cigarette smoking remains the leading cause of preventable disease and death in the United States and few tobacco users achieve sustained abstinence, underscoring the need for alternative treatments. The endocannabinoid system can modulate the reinforcing effects of nicotine and may be a target for development of pharmacotherapies for tobacco cessation. The cannabinoid type 1 receptor receptor inverse agonist/antagonist rimonabant has demonstrated efficacy in increasing tobacco abstinence rates in clinical trials, though it was abandoned as a viable medication due to adverse psychiatric side effects. Compounds that have similar pharmacology to rimonabant, but without the adverse psychiatric side effect profile may be efficacious for tobacco cessation. Cannabidiol (CBD) is a naturally occurring constituent of the cannabis plant that has been well tolerated in clinical studies and has low abuse liability. CBD has demonstrated anxiolytic, antipsychotic, and antidepressant effects, and can reduce appetite, suggesting that it may reduce known nicotine withdrawal symptoms associated with relapse. One clinical study provided initial evidence that CBD may be useful to promote tobacco cessation, however, the mechanism by which smoking was reduced is not clear and appropriate dosing remains unknown. This research will apply a rigorous methodological approach as an early screener for potential pharmacotherapies for tobacco dependence. This approach will utilize systematic dose administration and biochemical verification of smoking abstinence to evaluate CBD as a potential pharmacotherapy for tobacco cessation. A double-blind, within-subject, double-crossover design will be used to compare the effect of twice-daily oral CBD and matched placebo on short-term tobacco abstinence, and explore potential mechanisms underlying the effect of CBD on tobacco withdrawal, negative affect, and reinforcement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use, Tobacco Smoking, Tobacco Dependence, Tobacco Use Disorder, Tobacco Use Cessation
Keywords
Tobacco, Smoking, Cannabidiol, CBD

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be counterbalanced across participants.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Within-Subjects Dose Conditions
Arm Type
Experimental
Arm Description
All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be counterbalanced across participants. Thus, comparisons of the drug conditions on outcome measures will be compared within-subjects (e.g., between drug and placebo) and not between arms.
Arm Title
Additional Within-Subjects Dose Conditions
Arm Type
Experimental
Arm Description
All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be counterbalanced across participants. Thus, comparisons of the drug conditions on outcome measures will be compared within-subjects (e.g., between drug and placebo) and not between arms.
Intervention Type
Drug
Intervention Name(s)
300 mg Cannabidiol
Intervention Description
300 mg CBD in Medium Chain Triglyceride oil b.i.d.
Intervention Type
Drug
Intervention Name(s)
600 mg Cannabidiol
Intervention Description
600 mg CBD in Medium Chain Triglyceride oil b.i.d.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Medium Chain Triglyceride oil
Primary Outcome Measure Information:
Title
biochemically-verified tobacco abstinence as assessed by expired carbon monoxide
Description
Biochemically-verified tobacco abstinence as assessed by expired carbon monoxide part per million during the 4-day practice quit attempt of each drug condition.
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Smoking Puff Topography
Description
smoking puff topography will be collected each Monday during simulated quit attempt weeks (2, 4, and 6).
Time Frame
Change between simulated quit attempt (weeks 2, 4, and 6).
Title
Cigarette Purchase Task
Description
Cigarette Purchase Task will be collected each Monday during simulated quit attempt weeks (2, 4, and 6).
Time Frame
Change between simulated quit attempt (weeks 2, 4, and 6).
Title
Modified Cigarette Evaluation Scale
Description
Modified Cigarette Evaluation Scale will be collected each Monday during simulated quit attempt weeks (2, 4, and 6).
Time Frame
Change between simulated quit attempt (weeks 2, 4, and 6).
Title
Tobacco Smoking as assessed by self report
Description
Self-reported cigarettes per day
Time Frame
Change between simulated quit attempt (weeks 2, 4, and 6).
Title
Tobacco Withdrawal as assessed by the Minnesota Nicotine Withdrawal Scale
Description
Minnesota Nicotine Withdrawal Scale Total Score (range 0 - 36) higher scores equate with greater withdrawal
Time Frame
2 weeks
Title
Tobacco Withdrawal as assessed by the Questionnaire of Smoking Urges - Brief
Description
Questionnaire of Smoking Urges - Brief - Ten item questionnaire contains two 5-item factor scores - higher scores equate with greater smoking urge
Time Frame
2 weeks
Title
Tobacco Withdrawal as assessed by the Positive and Negative Affect Scale
Description
Positive and Negative Affect Scale - composed of 20 items, 10 measuring positive affect and 10 measuring negative affect. Scores range from 1 to 5 corresponding with extent to which the affect was experienced in the specified timeframe.
Time Frame
2 weeks
Title
Tobacco Withdrawal as assessed by the Hospital Anxiety and Depression Scale
Description
Hospital Anxiety and Depression Scale - 14 item assessment of anxiety and depression. Each item measured on a 4-point scale. Higher scores equate with greater depression/anxiety.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 by either 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, vital signs, and screening urine and blood tests as determined by a licensed medical professional. For women of children bearing potential and men with female partners of child-bearing potential, must be willing to use an effective form of contraception during the study and for at least 30 days after the last study drug administration. Acceptable forms of contraception include: double barrier contraception or a combination of a barrier contraception and a hormonal implant, injectable, combined oral contraceptive, or a male partner who has had a vasectomy; intrauterine device or tubal ligation. Exclusion Criteria: Meet Diagnostic and Statistical Manual-V criteria for substance use disorders except for nicotine or tobacco use disorders Are currently receiving or interested in immediately receiving behavioral treatment or medication for smoking cessation Test positive for drugs of abuse (except nicotine) and/or breath alcohol test at study admission Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity. Have a lifetime history of suicidal behavior (i.e. past suicide attempt), or current suicidal behavior or ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding. Use of an over the counter, systemic or topical drug(s), herbal supplement(s), or vitamin(s) 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 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 study result or the safety of the participant. This includes any medication metabolized via 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 part of a research study within 30 days of study participation. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dustin C Lee, PhD
Phone
410-550-4035
Email
dlee214@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dustin C Lee, PhD
Organizational Affiliation
Behavioral Pharmacology Research Unit, Johns Hopkins Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Behavioral Pharmacology Research Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dustin C Lee, PhD
Phone
410-550-4035
Email
dlee214@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not currently a plan to make individual participant data available to other researchers.

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Oral Cannabidiol for Tobacco Cessation

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