A Randomized Controlled Test of the Effects of CHI-554 on Fear.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-05-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a randomized, double-blind, placebo-controlled phase 2b clinical trial examining the effects of CHI-554 (CBD) on Fear (F-01)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cannabinoid Augmentation of Fear Response in Humans

NCT01665573

Fear Conditioning

COMPLETED EARLY_PHASE1

Cannabidiol Effects on Learning and Anxiety

NCT05283382

Anxiety and Fear

RECRUITING EARLY_PHASE1

Cannabidiol Effects on Fear Extinction in Social Phobia

NCT06123702

Social Anxiety Disorder

NOT_YET_RECRUITING EARLY_PHASE1

Cannabidiol as a Treatment for Social Anxiety Disorder (R61)

NCT05571592

Social Anxiety Disorder

COMPLETED PHASE2

Safety, Tolerability, and Efficacy of RLS103 in Subjects With Acute Anxiety Within Social Anxiety Disorder (SAD)

NCT05429788

Social Anxiety Disorder

WITHDRAWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will examine the potential of a novel formulation of hemp-derived CBD (CHI-554) to reduce fear elicited via a safe, well-established, controlled, laboratory-based carbon dioxide (CO2)-enriched air biological challenge that causes abrupt increases in bodily arousal.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Fear Panic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase 2b, randomized, double-blind, placebo-controlled study

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

This is a double-blind study. Investigators, study personnel, and participants will be blinded to the group assignment during the study

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

150 mg CBD

Group Type EXPERIMENTAL

CHI-554

Intervention Type DRUG

hemp-derived CBD in MCT oil

Group 2

300 mg CBD

Group Type EXPERIMENTAL

CHI-554

Intervention Type DRUG

hemp-derived CBD in MCT oil

Group 3

600 mg CBD

Group Type EXPERIMENTAL

CHI-554

Intervention Type DRUG

hemp-derived CBD in MCT oil

Group 4

Placebo MCT oil

Group Type PLACEBO_COMPARATOR

CHI-554

Intervention Type DRUG

hemp-derived CBD in MCT oil

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CHI-554

hemp-derived CBD in MCT oil

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Person is between 18 and 55-years-old (inclusive).
2. Person has a BMI between 18 and 35 kg/m2 (inclusive).
3. Person is willing and able to provide informed consent and attend a 3.5-hour, in-person session.
4. Woman of childbearing potential must not be pregnant or currently breastfeeding.
5. If person uses medication, the person has maintained a stable dose and regimen on existing medications for at least 30 days prior to participation in the study and throughout the study.
6. Person agrees to abide by all study restrictions and comply with all study procedures.

Exclusion Criteria

1. Person has a known history of significant allergic condition, significant hypersensitivity to the IP, or allergic reaction to cannabis, cannabinoid medications, hemp products, or excipients of the IP.
2. Person has been exposed to any investigational drug or device \< 30 days prior to screening or plans to take an investigational drug in the near future (within 30 days).
3. Person has used cannabis, synthetic cannabinoid or cannabinoid analogue (e.g., dronabinol, nabilone), synthetic cannabinoid receptor agonist (e.g., spice, K2), or any CBD- or delta-9- tetrahydrocannabinol (THC)-containing product within 30 days of screening or during the study.
4. Person is currently prescribed medications with likely THC- or CBD- interactions (e.g., warfarin, clobazam, valproic acid, phenobarbital, mechanistic target of rapamycin \[mTOR\] inhibitors, oral tacrolimus, St. John's wort; Epidiolex).
5. Person is currently prescribed and using a medication used in the treatment of anxiety disorders (e.g., selective serotonin uptake inhibitors, venlafaxine, buspirone, benzodiazepines, hydroxyzine, tiagabine, gabapentin, valproate, lamotrigine, topiramate, beta blockers, clonidine, guanfacine, atypical antipsychotics);
6. Person has a positive drug screen for THC, barbiturates, amphetamines, benzodiazepines, and/or opiates at baseline assessment.
7. Person meets diagnostic criteria for a current DSM-5 diagnosis indexed via the MINI.
8. Person meets criteria for a lifetime history of an unexpected or unprovoked panic attack indexed via the MINI.
9. Person endorses current suicidal intent as indexed via the C-SSRS.
10. Person reports a history of being diagnosed with a respiratory or lung disease (including asthma attacks), cardiac or pulmonary disease, epilepsy, narcolepsy, sleep apnea, anemia, or renal disease during a medical history interview.
11. Person has participated in a study that used a CO2-enriched air procedure.
12. Person has received formal training to tolerate elevated levels of CO2 or bodily arousal (such as free diver training or interoceptive exposure-based treatment).
13. Any other clinically significant disease or disorder or abnormal findings during screening or the baseline assessment that, in the opinion of the investigator, may either put the person at risk because of participation in the study, may confound the results of the study, or affect the person's ability to participate in the study.
14. Person has an acute or progressive disease that is likely to interfere with the objectives of the study, or the ability to adhere to protocol requirements.
15. Woman of childbearing potential, unless she has not engaged in vaginal intercourse or she has used effective contraception when doing so (for example, oral contraception, double barrier, intra-uterine device) for at least 30 days prior to the study.
16. Woman of childbearing potential, unless willing to ensure that she or her partner use effective contraception (for example, oral contraception, double barrier, intra-uterine device) during the study and for 30 days thereafter (however, a male condom should not be used in conjunction with a female condom).
17. Man whose partner is of childbearing potential, unless willing to ensure that he or his partner use effective contraception (for example, oral contraception, double barrier, intra-uterine device) during the study and for 30 days thereafter (however, a male condom should not be used in conjunction with a female condom).
18. Person has history of diagnosis related to hepatic function and/or significantly impaired hepatic function (alanine aminotransferase \[ALT\] \>5 ´ upper limit of normal \[ULN\] or total bilirubin \[TBL\] \>2 ´ ULN) OR the ALT or aspartate aminotransferase (AST) \>3 ´ ULN and TBL \>2 ´ ULN (or international normalized ratio \[INR\] \>1.5).
19. Person demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes