Cannabis Use DisorderPhase 1NCT03398083
Evaluation of the Effects of Cannabidiol (CBD) Compared to Delta-9-Tetrahydrocannabinol (THC) and Alprazolam
A Phase 1 study testing THC, Alprazolam and CBD in people with Cannabis Use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- THC, Alprazolam and CBD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2017to 30 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- ≥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.
Who cannot join
- contact site directly for more information
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- THC, Alprazolam, Placebo oral capsule, CBD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THCDrug
THC capsule
AlprazolamDrug
Also called Xanax
Alpraxolam capsule
Placebo oral capsuleDrug
Also called Placebo
Sugar pill capsule
CBDDrug
CBD capsule
| Study group | Role | What they receive |
|---|---|---|
| CBD (500 mg) | Active comparator | CBD (500 mg) capsule by mouth one time during the 18 day treatment period Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: THC; Drug: Alprazolam; Drug: CBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 days
Secondary outcomes (3)
Incidence of Increased Vital Signs
Number of participants with adverse events as assessed by vital signs
Measured: 25 days
Incidence of Increased ECG Reading
Number of participants with adverse events as assessed by ECG
Measured: 25 days
Incidence of Clinically Significant Laboratory Values
Number of participants with adverse events as assessed by laboratory changes
Measured: 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start4 Dec 2017
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Debra Kelsh, MD, Principal investigator, Vince and Associates Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398083
- Sponsor's protocol ID
- NIDA-CBD-Phase1-001
- Status last verified
- Jun 2018
- First submitted
- 18 Dec 2017
- Last updated
- 14 Jun 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03398083
- Acronym / sponsor ID
- NIDA-CBD-Phase1-001
- Conditions
- Cannabis Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CBD (500 mg) | Active comparator | Drug: THC, Drug: Alprazolam, Drug: Placebo oral capsuleCBD (500 mg) capsule by mouth one time during the 18 day treatment period |
| CBD (1000 mg) | Active comparator | Drug: THC, Drug: Alprazolam, Drug: Placebo oral capsuleCBD (1000 mg) capsule by mouth one time during the 18 day treatment period |
| THC (2.5 mg) | Active comparator | Drug: Alprazolam, Drug: Placebo oral capsule, Drug: CBDTHC 2.5 mg capsule by mouth one time during the 18 day treatment period |
| THC (30 mg) | Active comparator | Drug: Alprazolam, Drug: Placebo oral capsule, Drug: CBDTHC 30 mg capsule by mouth one time during the 18 day treatment period |
| Alprazolam | Active comparator | Drug: THC, Drug: Placebo oral capsule, Drug: CBDAlpraxolam 1.5 mg capsule by mouth one time during the 18 day treatment period |
| Placebo Oral Capsule | Placebo comparator | Drug: THC, Drug: Alprazolam, Drug: CBDPlacebo capsule by mouth one time during the 18 day treatment period |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (1 listed)
- contact site directly for more information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THCTHC capsule | Drug | Alprazolam, CBD (1000 mg), CBD (500 mg), Placebo Oral Capsule |
| AlprazolamAlso: XanaxAlpraxolam capsule | Drug | CBD (1000 mg), CBD (500 mg), Placebo Oral Capsule, THC (2.5 mg), THC (30 mg) |
| Placebo oral capsuleAlso: PlaceboSugar pill capsule | Drug | Alprazolam, CBD (1000 mg), CBD (500 mg), THC (2.5 mg), THC (30 mg) |
| CBDCBD capsule | Drug | Alprazolam, Placebo Oral Capsule, THC (2.5 mg), THC (30 mg) |
Primary outcome
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.
3 secondary outcomes
Incidence of Increased Vital Signs
Time frame: 25 days
Incidence of Increased ECG Reading
Time frame: 25 days
Incidence of Clinically Significant Laboratory Values
Time frame: 25 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Kelsh, MD principal investigator
Vince and Associates Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing THC, Alprazolam and CBD in people with Cannabis Use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 18 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2018.