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

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

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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:

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Contacts and Locations

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

More Information

• Responsible Party: National Institute on Drug Abuse (NIDA)
• ClinicalTrials.gov Identifier: NCT03398083
• Other Study ID Numbers: NIDA-CBD-Phase1-001
• First Posted: January 12, 2018
• 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:

Marijuana Abuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Alprazolam; 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