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

NCT ID: NCT03398083

Last Updated: 2018-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-04
• Study Completion Date: 2018-05-30

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.

Conditions

Cannabis Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

CBD (500 mg)

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

Group Type: ACTIVE_COMPARATOR

THC

Intervention Type: DRUG

THC capsule

Alprazolam

Intervention Type: DRUG

Alpraxolam capsule

Placebo oral capsule

Intervention Type: DRUG

Sugar pill capsule

CBD (1000 mg)

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

Group Type: ACTIVE_COMPARATOR

THC

Intervention Type: DRUG

THC capsule

Alprazolam

Intervention Type: DRUG

Alpraxolam capsule

Placebo oral capsule

Intervention Type: DRUG

Sugar pill capsule

THC (2.5 mg)

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

Group Type: ACTIVE_COMPARATOR

Alprazolam

Intervention Type: DRUG

Alpraxolam capsule

Placebo oral capsule

Intervention Type: DRUG

Sugar pill capsule

CBD

Intervention Type: DRUG

CBD capsule

THC (30 mg)

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

Group Type: ACTIVE_COMPARATOR

Alprazolam

Intervention Type: DRUG

Alpraxolam capsule

Placebo oral capsule

Intervention Type: DRUG

Sugar pill capsule

CBD

Intervention Type: DRUG

CBD capsule

Alprazolam

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

Group Type: ACTIVE_COMPARATOR

THC

Intervention Type: DRUG

THC capsule

Placebo oral capsule

Intervention Type: DRUG

Sugar pill capsule

CBD

Intervention Type: DRUG

CBD capsule

Placebo Oral Capsule

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

Group Type: PLACEBO_COMPARATOR

THC

Intervention Type: DRUG

THC capsule

Alprazolam

Intervention Type: DRUG

Alpraxolam capsule

CBD

Intervention Type: DRUG

CBD capsule

Interventions

THC

THC capsule

Intervention Type: DRUG

Alprazolam

Alpraxolam capsule

Intervention Type: DRUG

Placebo oral capsule

Sugar pill capsule

Intervention Type: DRUG

CBD

CBD capsule

Intervention Type: DRUG

Other Intervention Names

Xanax; Placebo

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debra Kelsh, MD

Role: PRINCIPAL_INVESTIGATOR

Vince and Associates Clinical Research

Locations

Debra Kelsh, MD

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

NIDA-CBD-Phase1-001

Identifier Type: -

Identifier Source: org_study_id