Evaluation of the Effects of Cannabidiol (CBD) Compared to Delta-9-Tetrahydrocannabinol (THC) and Alprazolam
- Conditions
- Cannabis Use Disorder
- Interventions
- Registration Number
- NCT03398083
- Lead Sponsor
- National Institute on Drug Abuse (NIDA)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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Must understand and provide written informed consent prior to the initiation of any protocol-specific procedures.
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Male or female subjects 18 to 55 years of age, inclusive.
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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.
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Healthy, as determined by no clinically significant medical history, physical examination,
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12-lead ECG, vital signs or laboratory (including hematology, clinical chemistry biochemistry, urinalysis, and serology) findings at Screening, as judged by the investigator.
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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.
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Must pass Qualification Phase eligibility criteria.
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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.
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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.
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Able to speak, read, and understand English sufficiently to allow completion of all study assessments.
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Must be willing and able to abide by all study requirements and restrictions.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CBD (500 mg) Alprazolam CBD (500 mg) capsule by mouth one time during the 18 day treatment period CBD (500 mg) Placebo oral capsule CBD (500 mg) capsule by mouth one time during the 18 day treatment period CBD (1000 mg) Placebo oral capsule CBD (1000 mg) capsule by mouth one time during the 18 day treatment period THC (2.5 mg) Placebo oral capsule THC 2.5 mg capsule by mouth one time during the 18 day treatment period THC (30 mg) Placebo oral capsule THC 30 mg capsule by mouth one time during the 18 day treatment period Alprazolam Placebo oral capsule Alpraxolam 1.5 mg capsule by mouth one time during the 18 day treatment period THC (2.5 mg) CBD THC 2.5 mg capsule by mouth one time during the 18 day treatment period CBD (500 mg) THC CBD (500 mg) capsule by mouth one time during the 18 day treatment period CBD (1000 mg) THC CBD (1000 mg) capsule by mouth one time during the 18 day treatment period CBD (1000 mg) Alprazolam CBD (1000 mg) capsule by mouth one time during the 18 day treatment period Alprazolam CBD Alpraxolam 1.5 mg capsule by mouth one time during the 18 day treatment period THC (2.5 mg) Alprazolam THC 2.5 mg capsule by mouth one time during the 18 day treatment period Alprazolam THC Alpraxolam 1.5 mg capsule by mouth one time during the 18 day treatment period THC (30 mg) Alprazolam THC 30 mg capsule by mouth one time during the 18 day treatment period THC (30 mg) CBD THC 30 mg capsule by mouth one time during the 18 day treatment period Placebo Oral Capsule THC Placebo capsule by mouth one time during the 18 day treatment period Placebo Oral Capsule Alprazolam Placebo capsule by mouth one time during the 18 day treatment period Placebo Oral Capsule CBD Placebo capsule by mouth one time during the 18 day treatment period
- Primary Outcome Measures
Name Time Method Visual Analog Scale 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.
- Secondary Outcome Measures
Name Time Method Incidence of Increased Vital Signs 25 days Number of participants with adverse events as assessed by vital signs
Incidence of Increased ECG Reading 25 days Number of participants with adverse events as assessed by ECG
Incidence of Clinically Significant Laboratory Values 25 days Number of participants with adverse events as assessed by laboratory changes
Trial Locations
- Locations (1)
Debra Kelsh, MD
🇺🇸Overland Park, Kansas, United States