ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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)

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.

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Drug: THC Drug: Alprazolam Drug: Placebo oral capsule Drug: CBD Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : December 4, 2017
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Alprazolam

Arm Intervention/treatment
Active Comparator: CBD (500 mg)
CBD (500 mg) capsule by mouth one time during the 18 day treatment period
Drug: THC
THC capsule

Drug: Alprazolam
Alpraxolam capsule
Other Name: Xanax

Drug: Placebo oral capsule
Sugar pill capsule
Other Name: Placebo

Active Comparator: CBD (1000 mg)
CBD (1000 mg) capsule by mouth one time during the 18 day treatment period
Drug: THC
THC capsule

Drug: Alprazolam
Alpraxolam capsule
Other Name: Xanax

Drug: Placebo oral capsule
Sugar pill capsule
Other Name: Placebo

Active Comparator: THC (2.5 mg)
THC 2.5 mg capsule by mouth one time during the 18 day treatment period
Drug: Alprazolam
Alpraxolam capsule
Other Name: Xanax

Drug: Placebo oral capsule
Sugar pill capsule
Other Name: Placebo

Drug: CBD
CBD capsule

Active Comparator: THC (30 mg)
THC 30 mg capsule by mouth one time during the 18 day treatment period
Drug: Alprazolam
Alpraxolam capsule
Other Name: Xanax

Drug: Placebo oral capsule
Sugar pill capsule
Other Name: Placebo

Drug: CBD
CBD capsule

Active Comparator: Alprazolam
Alpraxolam 1.5 mg capsule by mouth one time during the 18 day treatment period
Drug: THC
THC capsule

Drug: Placebo oral capsule
Sugar pill capsule
Other Name: Placebo

Drug: CBD
CBD capsule

Placebo Comparator: Placebo Oral Capsule
Placebo capsule by mouth one time during the 18 day treatment period
Drug: THC
THC capsule

Drug: Alprazolam
Alpraxolam capsule
Other Name: Xanax

Drug: CBD
CBD capsule




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Incidence of Increased Vital Signs [ Time Frame: 25 days ]
    Number of participants with adverse events as assessed by vital signs

  2. Incidence of Increased ECG Reading [ Time Frame: 25 days ]
    Number of participants with adverse events as assessed by ECG

  3. Incidence of Clinically Significant Laboratory Values [ Time Frame: 25 days ]
    Number of participants with adverse events as assessed by laboratory changes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398083


Locations
United States, Kansas
Debra Kelsh, MD
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Debra Kelsh, MD Vince and Associates Clinical Research

Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT03398083     History of Changes
Other Study ID Numbers: NIDA-CBD-Phase1-001
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alprazolam
Dronabinol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hallucinogens
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists