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

National Institutes of Health (NIH)

Status and phase: Completed; Phase 1

Conditions: Cannabis Use Disorder

Treatments: Drug: THC; Drug: Alprazolam; Drug: CBD; Drug: Placebo oral capsule

Study type: Interventional

Funder types: NIH

Identifiers

NCT03398083

NIDA-CBD-Phase1-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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42 participants in 6 patient groups, including a placebo group

CBD (500 mg)

Active Comparator group

Description:

CBD (500 mg) capsule by mouth one time during the 18 day treatment period

Treatment:

Drug: Placebo oral capsule

Drug: Alprazolam

Drug: THC

CBD (1000 mg)

Active Comparator group

Description:

CBD (1000 mg) capsule by mouth one time during the 18 day treatment period

Treatment:

Drug: Placebo oral capsule

Drug: Alprazolam

Drug: THC

THC (2.5 mg)

Active Comparator group

Description:

THC 2.5 mg capsule by mouth one time during the 18 day treatment period

Treatment:

Drug: Placebo oral capsule

Drug: Alprazolam

Drug: CBD

THC (30 mg)

Active Comparator group

Description:

THC 30 mg capsule by mouth one time during the 18 day treatment period

Treatment:

Drug: Placebo oral capsule

Drug: Alprazolam

Drug: CBD

Alprazolam

Active Comparator group

Description:

Alpraxolam 1.5 mg capsule by mouth one time during the 18 day treatment period

Treatment:

Drug: Placebo oral capsule

Drug: THC

Drug: CBD

Placebo Oral Capsule

Placebo Comparator group

Description:

Placebo capsule by mouth one time during the 18 day treatment period

Treatment:

Drug: Alprazolam

Drug: THC

Drug: CBD