Evaluation of the Effects of Cannabidiol (CBD) Compared to Delta-9-Tetrahydrocannabinol (THC) and Alprazolam
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| ClinicalTrials.gov Identifier: NCT03398083 |
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Recruitment Status :
Completed
First Posted : January 12, 2018
Last Update Posted : June 14, 2018
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Sponsor:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cannabis Use Disorder | Drug: THC Drug: Alprazolam Drug: Placebo oral capsule Drug: CBD | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 42 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Diagnostic |
| 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 |
| Actual Study Start Date : | December 4, 2017 |
| Actual Primary Completion Date : | May 30, 2018 |
| Actual Study Completion Date : | May 30, 2018 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Alprazolam
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: CBD (500 mg)
CBD (500 mg) capsule by mouth one time during the 18 day treatment period
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Drug: THC
THC capsule Drug: Alprazolam Alpraxolam capsule
Other Name: Xanax Drug: Placebo oral capsule Sugar pill capsule
Other Name: Placebo |
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Active Comparator: CBD (1000 mg)
CBD (1000 mg) capsule by mouth one time during the 18 day treatment period
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Drug: THC
THC capsule Drug: Alprazolam Alpraxolam capsule
Other Name: Xanax Drug: Placebo oral capsule Sugar pill capsule
Other Name: Placebo |
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Active Comparator: THC (2.5 mg)
THC 2.5 mg capsule by mouth one time during the 18 day treatment period
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Drug: Alprazolam
Alpraxolam capsule
Other Name: Xanax Drug: Placebo oral capsule Sugar pill capsule
Other Name: Placebo Drug: CBD CBD capsule |
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Active Comparator: THC (30 mg)
THC 30 mg capsule by mouth one time during the 18 day treatment period
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Drug: Alprazolam
Alpraxolam capsule
Other Name: Xanax Drug: Placebo oral capsule Sugar pill capsule
Other Name: Placebo Drug: CBD CBD capsule |
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Active Comparator: Alprazolam
Alpraxolam 1.5 mg capsule by mouth one time during the 18 day treatment period
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Drug: THC
THC capsule Drug: Placebo oral capsule Sugar pill capsule
Other Name: Placebo Drug: CBD CBD capsule |
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Placebo Comparator: Placebo Oral Capsule
Placebo capsule by mouth one time during the 18 day treatment period
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Drug: THC
THC capsule Drug: Alprazolam Alpraxolam capsule
Other Name: Xanax Drug: CBD CBD capsule |
Primary Outcome Measures :
- Visual Analog Scale [ Time Frame: 18 days ]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.
Secondary Outcome Measures :
- Incidence of Increased Vital Signs [ Time Frame: 25 days ]Number of participants with adverse events as assessed by vital signs
- Incidence of Increased ECG Reading [ Time Frame: 25 days ]Number of participants with adverse events as assessed by ECG
- Incidence of Clinically Significant Laboratory Values [ Time Frame: 25 days ]Number of participants with adverse events as assessed by laboratory changes
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398083
Locations
| United States, Kansas | |
| Debra Kelsh, MD | |
| Overland Park, Kansas, United States, 66212 | |
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
| Principal Investigator: | Debra Kelsh, MD | Vince and Associates Clinical Research |
| Responsible Party: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT03398083 History of Changes |
| Other Study ID Numbers: |
NIDA-CBD-Phase1-001 |
| First Posted: | January 12, 2018 Key Record Dates |
| Last Update Posted: | June 14, 2018 |
| Last Verified: | June 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
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Alprazolam Dronabinol Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Hallucinogens Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |