- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05317507
Safety of Co-Administered CHI-554 and Alcohol
January 12, 2023 updated by: Sara K Blaine, Auburn University
This is a Phase 1, randomized, double-blind study to assess the safety, tolerability, and effects of CHI-554 when co-administered with alcohol.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sara Blaine, PhD
- Phone Number: 334-844-4412
- Email: sara.blaine@auburn.edu
Study Locations
-
-
Alabama
-
Auburn, Alabama, United States, 36849
- Recruiting
- Auburn University
-
Contact:
- Ben Campbell
- Email: aubielab@auburn.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Is a healthy adult aged 21-65 years, inclusive, at the time of screening.
- Has a body mass index between 18 and 35 kg/m2 (inclusive).
- Reports at online screening (and confirmed at in-person screening) that has achieved a calculated blood alcohol concentration of at least .06% in the past month according to the Daily Drinking Questionnaire (Collins et al., 1985).
- Is judged by the Investigator to be in generally good health at screening based on participants' medical history, vital signs, and comprehensive metabolic panel test results. Laboratory results outside of the reference range but within acceptable limits must be documented as not clinically significant (NCS) at the discretion of the Investigator.
- Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.
- Able to read and write in English.
Exclusion Criteria:
- Women who are pregnant, lactating, breastfeeding, or planning a pregnancy.
- Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception (abstinence or the use of a highly effective method of contraception, including hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, or intrauterine device) from at least 21 days prior to the first dose of study medication until 28 days after the last dose of study medication.
- Has a history of epilepsy, hepatitis, clinically significant hepatic or renal impairment, or human immunodeficiency virus.
- Changes in the use of a prescription, over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) for 28 days prior to the Screening Visit.
- Current use of any known hepatotoxic medication.
- Has any clinically significant condition or abnormal finding at screening that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study IP.
- Has a history of a known significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to cannabis, including phytocannabinoids and cannabinoid analogues, or excipients utilized within the IP (e.g., coconut; coconut oil; medium-chain triglycerides).
- Has taken a medication with likely CBD-interactions, including warfarin, clobazam, valproic acid, phenobarbital, mTOR inhibitors, oral tacrolimus, and St. John's Wort within 28 days of the Screening Visit or during the study.
- Has taken grapefruit products and/or Seville oranges within the 7 days prior to the first Experimental Visit.
- Has used cannabis, synthetic cannabinoid or cannabinoid analogues (e.g., dronabinol, nabilone), hemp products, synthetic cannabinoid receptor agonists (e.g., Spice, K2), or any CBD- or THC-containing product (e.g., Sativex, Epidiolex) within 28 days of the Screening Visit or during the study.
- Has a past or current severe Alcohol Use Disorder as assessed by the Structured Clinical Interview Diagnostic (SCID) for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) at the Screening Visit.
- Has a past or current diagnosis of a significant psychiatric disorder, or current use of illicit drugs, as assessed by the SCID at the Screening Visit that would, in the opinion of the Investigator, affect the subject's ability to comply with the study requirements.
- Endorses current suicidal intent as assessed by the SCID at the Screening Visit.
- Has participated in any investigational product or device study within 30 days prior to the Screening Visit, or is scheduled to participate in another investigational product or device study during the course of this study.
- Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.
- Has a positive result on an alcohol breath test or urine drug screen for benzodiazepines, PCP, barbiturates, antidepressants, cocaine, amphetamine, methamphetamine, THC, and opiates at the Screening Visit or at any Experimental Visit.
- Self-reports current use of nicotine-containing products or nicotine replacement products as assessed by the SCID at the Screening Visit.
- Anyone with a history of hypersensitivity to cannabidiol will not be enrolled in the study. - To avoid any potential drug-drug interactions, participants must not be taking any of the following at any time during study participation: CYP3A4 or CYP2C19 Inducers, CYP1A2, CYP2B6, CYP2C8, CYP2C9, and CYP2C19 Substrates (e.g.,, theophylline, or tizanidine), CYP2B6 substrates (e.g., bupropion, efavirenz), uridine 5'-diphospho-glucuronosyltransferase 1A9 (UGT1A9) substrates (e.g., diflunisal, propofol, fenofibrate), and UGT2B7 substrates (e.g., gemfibrozil, lamotrigine, morphine, lorazepam), CYP2C8 and CYP2C9 (e.g., phenytoin) substrates, drugs that are metabolized by (i.e., are substrates of) CYP2C19 (e.g., diazepam), stiripentol, everolimus, sirolimus, tacrolimus, digoxin, and Valproate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Randomization order 1
Participants receive placebo at visit 1, 50 mg CBD at visit 2, and 100 mg CBD at visit 3 followed by a 4-week period of at home use of 100 mg CBD daily.
|
Placebo
50 mg
100 mg CBD
|
Experimental: Randomization order 2
Participants receive placebo at visit 1, 100 mg CBD at visit 2, and 50 mg CBD at visit 3 followed by a 4-week period of at home use of 100 mg CBD daily.
|
Placebo
50 mg
100 mg CBD
|
Experimental: Randomization order 3
Participants receive 50 mg CBD at visit 1, placebo at visit 2, and 100 mg CBD at visit 3 followed by a 4-week period of at home use of 100 mg CBD daily.
|
Placebo
50 mg
100 mg CBD
|
Experimental: Randomization order 4
Participants receive 50 mg CBD at visit 1, 100 mg CBD at visit 2, and placebo at visit 3 followed by a 4-week period of at home use of 100 mg CBD daily.
|
Placebo
50 mg
100 mg CBD
|
Experimental: Randomization order 5
Participants receive 100 mg CBD at visit 1, 50 mg CBD at visit 2, and placebo at visit 3 followed by a 4-week period of at home use of 100 mg CBD daily.
|
Placebo
50 mg
100 mg CBD
|
Experimental: Randomization order 6
Participants receive 100 mg CBD at visit 1, placebo at visit 2, and 50 mg CBD at visit 3 followed by a 4-week period of at home use of 100 mg CBD daily.
|
Placebo
50 mg
100 mg CBD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events/Serious Adverse Events
Time Frame: Day 0
|
Adverse Events/Serious Adverse Events
|
Day 0
|
Adverse Events/Serious Adverse Events
Time Frame: Day 3
|
Adverse Events/Serious Adverse Events
|
Day 3
|
Adverse Events/Serious Adverse Events
Time Frame: Day 6
|
Adverse Events/Serious Adverse Events
|
Day 6
|
Adverse Events/Serious Adverse Events
Time Frame: Day 34
|
Adverse Events/Serious Adverse Events
|
Day 34
|
Change from baseline in Alanine aminotransferase (ALT)
Time Frame: Day 0
|
Alanine aminotransferase (ALT)
|
Day 0
|
Change from baseline in Alanine aminotransferase (ALT)
Time Frame: Day 3
|
Alanine aminotransferase (ALT)
|
Day 3
|
Change from baseline in Alanine aminotransferase (ALT)
Time Frame: Day 6
|
Alanine aminotransferase (ALT)
|
Day 6
|
Change from baseline in Alanine aminotransferase (ALT)
Time Frame: Day 34
|
Alanine aminotransferase (ALT)
|
Day 34
|
Change from baseline in blood pressure
Time Frame: Day 0
|
Blood pressure (systolic and diastolic)
|
Day 0
|
Change from baseline in blood pressure
Time Frame: Day 3
|
Blood pressure (systolic and diastolic)
|
Day 3
|
Change from baseline in blood pressure
Time Frame: Day 6
|
Blood pressure (systolic and diastolic)
|
Day 6
|
Change from baseline in blood pressure
Time Frame: Day 34
|
Blood pressure (systolic and diastolic)
|
Day 34
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak Blood Alcohol Level (BAL)
Time Frame: Day 0
|
Peak BAL during experimental visits
|
Day 0
|
Peak Blood Alcohol Level (BAL)
Time Frame: Day 3
|
Peak BAL during experimental visits
|
Day 3
|
Peak Blood Alcohol Level (BAL)
Time Frame: Day 6
|
Peak BAL during experimental visits
|
Day 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 9, 2022
Primary Completion (Anticipated)
March 23, 2023
Study Completion (Anticipated)
March 23, 2023
Study Registration Dates
First Submitted
March 16, 2022
First Submitted That Met QC Criteria
April 6, 2022
First Posted (Actual)
April 7, 2022
Study Record Updates
Last Update Posted (Estimate)
January 16, 2023
Last Update Submitted That Met QC Criteria
January 12, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 710022US1313
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Adults
-
KU LeuvenCompletedHealthy Older Adults | Ill Older AdultsBelgium
-
Samsung Medical CenterTerminatedHealthy Aging | Healthy AdultsKorea, Republic of
-
King Abdulaziz UniversityUniversity College Dublin; Royal College of Surgeons, IrelandRecruitingHealthy Adults | Healthy NutritionSaudi Arabia
-
S-Infinity Pharmaceuticals Co., LtdRecruiting
-
Mirati Therapeutics Inc.CompletedHealthy AdultsUnited States
-
National Yang Ming UniversityCompleted
-
EicOsis Human Health Inc.CompletedHealthy AdultsUnited States
-
Wecare Probiotics Co., Ltd.Completed
-
University of Massachusetts, AmherstNational Institute on Deafness and Other Communication Disorders (NIDCD)Completed
-
University Hospital Inselspital, BerneCompletedHealthy | AdultsSwitzerland
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States