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

NCT03398083 | Completed Phase 1 FDA Drug

• 1 other identifier: NIDA-CBD-Phase1-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of Increased Vital Signs

  25 days

• Incidence of Increased ECG Reading

  25 days

• Incidence of Clinically Significant Laboratory Values

  25 days

Study Arms (6)

CBD (500 mg)

ACTIVE COMPARATOR

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

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

CBD (1000 mg)

ACTIVE COMPARATOR

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

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

THC (2.5 mg)

ACTIVE COMPARATOR

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

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

THC (30 mg)

ACTIVE COMPARATOR

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

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

Alprazolam

ACTIVE COMPARATOR

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

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

Placebo Oral Capsule

PLACEBO COMPARATOR

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

Drug: THC; Drug: Alprazolam; Drug: CBD

Interventions

THC DRUG

THC capsule

Alprazolam; CBD (1000 mg); CBD (500 mg); Placebo Oral Capsule

Alprazolam DRUG

Alpraxolam capsule

Also known as: Xanax

CBD (1000 mg); CBD (500 mg); Placebo Oral Capsule; THC (2.5 mg); THC (30 mg)

Placebo oral capsule DRUG

Sugar pill capsule

Also known as: Placebo

Alprazolam; CBD (1000 mg); CBD (500 mg); THC (2.5 mg); THC (30 mg)

CBD DRUG

CBD capsule

Alprazolam; Placebo Oral Capsule; THC (2.5 mg); THC (30 mg)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• contact site directly for more information

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

Debra Kelsh, MD

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Interventions

Dronabinol; Alprazolam

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Debra Kelsh, MD

  Vince and Associates Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 12, 2018
• Study Start: December 4, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

US (1)