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

Cannabis Use Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398083
• Other study ID #: NIDA-CBD-Phase1-001
• Status: Completed
• Phase: Phase 1
• Start date: December 4, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: June 2018
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Use Disorder

Intervention

Drug:
• THC
THC capsule
• Alprazolam
Alpraxolam capsule
• Placebo oral capsule
Sugar pill capsule
• CBD
CBD capsule

Locations

Country	Name	City	State
United States	Debra Kelsh, MD	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	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.	18 days
Secondary	Incidence of Increased Vital Signs	Number of participants with adverse events as assessed by vital signs	25 days
Secondary	Incidence of Increased ECG Reading	Number of participants with adverse events as assessed by ECG	25 days
Secondary	Incidence of Clinically Significant Laboratory Values	Number of participants with adverse events as assessed by laboratory changes	25 days