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Evaluation of the Effects of Cannabidiol (CBD) Compared to Delta-9-Tetrahydrocannabinol (THC) and Alprazolam

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ClinicalTrials.gov Identifier: NCT03398083
Recruitment Status : Completed
First Posted : January 12, 2018
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE December 18, 2017
First Posted Date  ICMJE January 12, 2018
Last Update Posted Date June 14, 2018
Actual Study Start Date  ICMJE December 4, 2017
Actual Primary Completion Date May 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
Visual Analog Scale [ Time Frame: 18 days ]
Subjects will complete 13 scales. Each Visual Analog Scale is a self-administered assessment evaluating the subjective effects of a study agent. Subjects will be instructed to respond to the questions with regards to how they feel at that moment of the assessment on a 100 mm Likert Scale with 0 being "Not at all" and 100 being "Very" or "Extremely". All scales are unipolar or bipolar.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03398083 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
  • Incidence of Increased Vital Signs [ Time Frame: 25 days ]
    Number of participants with adverse events as assessed by vital signs
  • Incidence of Increased ECG Reading [ Time Frame: 25 days ]
    Number of participants with adverse events as assessed by ECG
  • Incidence of Clinically Significant Laboratory Values [ Time Frame: 25 days ]
    Number of participants with adverse events as assessed by laboratory changes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Effects of Cannabidiol (CBD) Compared to Delta-9-Tetrahydrocannabinol (THC) and Alprazolam
Official Title  ICMJE A Human Abuse Potential Study to Evaluate the Subjective and Physiological Effects of Cannabidiol (CBD) Compared to Delta-9-Tetrahydrocannabinol (THC) and Alprazolam in an Inpatient Setting
Brief Summary The purpose of this study is to evaluate the abuse potential of CBD to determine whether it should remain as a Schedule I drug under the Controlled Substances Act, or be recommended for decontrol.
Detailed Description This is a single-dose, randomized, double-blind, placebo- and active-controlled crossover study that evaluates CBD in comparison with THC, alprazolam, and placebo in healthy recreational drug users.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Cannabis Use Disorder
Intervention  ICMJE
  • Drug: THC
    THC capsule
  • Drug: Alprazolam
    Alpraxolam capsule
    Other Name: Xanax
  • Drug: Placebo oral capsule
    Sugar pill capsule
    Other Name: Placebo
  • Drug: CBD
    CBD capsule
Study Arms  ICMJE
  • Active Comparator: CBD (500 mg)
    CBD (500 mg) capsule by mouth one time during the 18 day treatment period
    Interventions:
    • Drug: THC
    • Drug: Alprazolam
    • Drug: Placebo oral capsule
  • Active Comparator: CBD (1000 mg)
    CBD (1000 mg) capsule by mouth one time during the 18 day treatment period
    Interventions:
    • Drug: THC
    • Drug: Alprazolam
    • Drug: Placebo oral capsule
  • Active Comparator: THC (2.5 mg)
    THC 2.5 mg capsule by mouth one time during the 18 day treatment period
    Interventions:
    • Drug: Alprazolam
    • Drug: Placebo oral capsule
    • Drug: CBD
  • Active Comparator: THC (30 mg)
    THC 30 mg capsule by mouth one time during the 18 day treatment period
    Interventions:
    • Drug: Alprazolam
    • Drug: Placebo oral capsule
    • Drug: CBD
  • Active Comparator: Alprazolam
    Alpraxolam 1.5 mg capsule by mouth one time during the 18 day treatment period
    Interventions:
    • Drug: THC
    • Drug: Placebo oral capsule
    • Drug: CBD
  • Placebo Comparator: Placebo Oral Capsule
    Placebo capsule by mouth one time during the 18 day treatment period
    Interventions:
    • Drug: THC
    • Drug: Alprazolam
    • Drug: CBD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2018)
42
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2018)
56
Actual Study Completion Date  ICMJE May 30, 2018
Actual Primary Completion Date May 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must understand and provide written informed consent prior to the initiation of any protocol-specific procedures.
  • Male or female subjects 18 to 55 years of age, inclusive.
  • Body mass index (BMI) within the range of 19.0 to 30.0 kg/m2, inclusive, and a minimum weight of at least 50.0 kg.
  • Healthy, as determined by no clinically significant medical history, physical examination,
  • 12-lead ECG, vital signs or laboratory (including hematology, clinical chemistry biochemistry, urinalysis, and serology) findings at Screening, as judged by the investigator.
  • Must be a recreational drug user, defined as meeting all of the following criteria:

    • ≥10 lifetime non-therapeutic experiences (i.e., for psychoactive effects) with CNS depressants (e.g., benzodiazepines, barbiturates, zolpidem, eszopiclone, propofol/fospropofol, gamma-hydroxy-butyrate).
    • ≥10 lifetime non-therapeutic experiences with cannabinoids (e.g., cannabis, hashish, THC, nabilone).
    • At least 3 non-therapeutic uses of a sedative, and at least 3 non-therapeutic uses of a cannabinoid, within the 3 months prior to Screening.
  • Must pass Qualification Phase eligibility criteria.
  • Female subjects of childbearing potential who are not abstinent must be using and willing to continue using medically acceptable contraception throughout the trial and for 30 days after last dose. In the context of this trial, highly effective methods of contraception are defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Such methods include hormonal contraceptives, intrauterine devices/hormone-releasing systems, double-barrier methods, bilateral tubal occlusion, vasectomized partner, or sexual abstinence. Abstinence is only acceptable as true (total) abstinence, when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • Non-vasectomized male subjects must agree to a highly effective method of contraception with female partner(s) of childbearing potential and may not donate sperm throughout the trial and for 90 days after the last study drug administration.
  • Able to speak, read, and understand English sufficiently to allow completion of all study assessments.
  • Must be willing and able to abide by all study requirements and restrictions.

Exclusion Criteria:

  • contact site directly for more information
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03398083
Other Study ID Numbers  ICMJE NIDA-CBD-Phase1-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute on Drug Abuse (NIDA)
Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Debra Kelsh, MD Vince and Associates Clinical Research
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP