Clinical trial NCT03398083: Evaluation of the Effects of Cannabidiol (CBD) Compared to Delta-9-Tetrahydrocannabinol (THC) and Alprazolam
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cannabis Use Disorder
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2018-01-12
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 18 days
Secondary outcomes:
measure: Incidence of Increased Vital Signs
timeFrame: 25 days
measure: Incidence of Increased ECG Reading
timeFrame: 25 days
measure: Incidence of Clinically Significant Laboratory Values
timeFrame: 25 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Debra Kelsh, MD
state: Kansas
Study officials:
affiliation: Vince and Associates Clinical Research
name: Debra Kelsh, MD
role: PRINCIPAL_INVESTIGATOR
References: