New Albany, California
Cannabidiol for Reducing Cigarette Use
General Experimental Design: This will be a randomized, double-blind, placebo-controlled, comparison study of Nantheia ATL5 (CBD) vs. placebo on smoking behavior in participants who have Tobacco Use Disorder (TUD) and have a desire for smoking cessation, conducted at CRI-Help, Inc., a residential substance use treatment center in N. Hollywood, CA. The investigators will instruct participants and provide support via text messages from the National Cancer Institute's Smokefree.gov website. Smokefree.gov offers free messaging programs that give encouragement, advice, and tips for becoming smoke-free and being healthier. The NCI website also helps people who smoke create a personalized quit plan that makes it easier to stay on track, get through hard times, and quit for good. Creating this plan will be part of baseline procedures. Randomization to Treatment, Sample Size: Participants will receive CBD at a dose of 800 mg per day or placebo (n = 60/group). The investigators will randomize by sex and age (18-30, greater than/equal to 31 years) to ensure equal representation across the groups. The investigators will use an intention-to-treat analysis, including data from all participants who are randomized (see below for power analysis). Dosing and Testing Schedule: After screening (Days -7 to 0) and baseline (Day 0) assessments, the study will comprise a 56-day (8-week) treatment period with follow up assessments at 1 and 3 months after termination of treatment as part of this trial. Measurements will be obtained at daily and weekly assessments during the 8-week treatment period. Measures Collected: A baseline assessment will include assay of blood plasma cotinine to indicate heaviness of smoking, and self-reports of smoking-related behaviors on the following smoking-related questionnaires: - Fagerström Test for Nicotine Dependence (FTND). This 6-item survey (~2 min) is closely linked to nicotine intake. - Smoking History Questionnaire. Developed in Dr. London's Lab, this 25-item survey (~5 min) queries age at initiation, longest quit attempt, number of quit attempts, reasons for quitting, and current smoking behavior (e.g., preferred brand, cigarettes per day, etc.). - Minnesota Nicotine Withdrawal Scale (MNWS) measures withdrawal symptoms: craving, irritability, anxiety, difficulty concentrating, restlessness, headache, drowsiness, and GI disturbances. These symptoms are scored on an ordinal scale [0 (not present) to 3 (severe)]. - General Anxiety Screener (GAD-7). This is a self-administered seven-item questionnaire that is used to measure or assess the severity of generalized anxiety disorder (GAD). The GAD-7 takes ~1-2 min to complete. - Patient Health Questoinnaire-9 (PHQ-9). This self-administered nine-item scale measures the degree of depression. The PHQ-9 only takes ~1-2 min to complete. Participants will self-report cigarette use and adverse events (AEs) each day using structured questionnaires. At screening and on days 7, 14, 28 and 56, the investigators will take vital signs and draw blood for clinical laboratory tests for safety, to assay cotinine as an index of heaviness of smoking, and to assay cannabinoids (CBD, anandamide, 2-AG); participants will complete the FTND, MNWS, GAD-7, and PHQ-9. At 1- and 3-month follow up, the investigators will take vital signs, measure CO in breath, and take the same behavioral/self-report measures as on Days 7, 14, 28 and 56. Retention: The index of retention will be the number of days a participant remains in the study. Assay of CBD, anandamide, 2-AG and cotinine: The investigators will use liquid chromatography/mass spectrometry-multiple reaction monitoring (LC/MS-MRM) assays. Internal standards are added after sample extracts are processed and injected onto a multi-mode column with reversed phase, cation and anion exchange capabilities. After equilibration and elution, column effluents are passed through an electrospray ion source attached to a triple quadrupole mass spectrometer, and MRM signals are recorded. Each compound is quantified by interpolation from response curves using data from internal standards and increasing concentrations of unlabeled authentic analytes. Risks and Minimization of Risk Risks associated with taking CBD include: - Increase in liver alanine aminotransferase enzymes (ALT test) - Increase in blood clotting (International Normalized Ratio, INR). Given the possibility that individuals with substance use disorders will participate in the study and may exhibit abnormality in liver function at baseline, liver function tests will be performed in screening, and individuals with abnormal values will be excluded. Abuse Potential of CBD: The DEA has classified CBD as a Schedule I drug In the United States, suggesting that CBD has a high potential for abuse, but the World Health Organization Expert Committee on Drug Dependence concluded that no abuse potential could be confirmed based on findings from animal and human research. The type of CBD used here is derived from hemp and contains less than 0.3% tetrahydrocannabinol (THC; i.e., the primary psychoactive ingredient in cannabis). CBD used in Nantheia ATL-5 is not considered a scheduled drug by the DEA. Note: Careful screening at baseline and ongoing monitoring of plasma levels for potential emergence of adverse events will be practiced, ensuring minimization of all risks. In addition, trial stopping rules were developed with the following criteria applied. Patient safety dose stopping and discontinuation criteria (no re-challenge): - ALT or AST >3 x ULN and [total bilirubin level (TBL) >2 x ULN or INR >1.5). - ALT or AST >3 x ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%). Other risks of CBD administration Possible effects on a fetus: There are no long-term studies in humans on CBD effects on fetal development; however, animal studies suggest that long-term use is safe, with very low potential for effects on a fetus at doses associated with human treatment. To minimize this potential risk, pregnancy is an exclusion criterion, and a participant who becomes pregnant will be withdrawn from the study. Risk of ovarian suppression: Animal studies have indicated this possibility. Female participants will undergo a hormonal battery at screening with ultrasound upon abnormal findings. Participants with evidence of ovarian suppression will be excluded. Ovarian function will also be tested during the treatment phase, and any abnormality followed up with referral for further investigation. This study will be conducted in a residential treatment facility. Thus, participants will be closely monitored, dosing will be controlled, and clinical and laboratory assessments will be done on a regular schedule. Participant Withdrawal from the Protocol: Participants can be withdrawn for safety (see stopping criteria above) and noncompliance with medication administration protocols. Decisions regarding safety will be made by the PI with advice from Co-Investigator Larissa Mooney, M.D. Participants will also be withdrawn upon leaving inpatient treatment at CRI-Help. Participants can decide on their own to withdraw from the protocol at any time without prejudice, and this will not affect their treatment at CRI-Help. All participants will receive compensation for all of the procedures/assessments completed. Drug Administration Details Investigational Product and Mode of Administration: Nantheia ATL5, which is CBD, extracted from hemp, at a 10% strength (softgel capsules with 100 mg/ml of CBD per capsule) or matching placebo. The formulation that was selected for this clinical trial contains CBD and excipients as here: 1. emulsifying agents: Cremophor EL (Polyoxyl 35 castor oil), Tween 80 (Polysorbate 80), Plurol® Oleique (polyglyceryl-3 dioleate); 2. cwe o-surfactant: propylene glycol; 3. oil: Labrosol® (caprylocapryol polyoxyl-8 glycerides), medium chain triglycerides; 4. antioxidant: BHT (butylated hydroxytoluene). Nantheia ATL5 Softgel Capsules will be manufactured by Baxco Pharmaceutical Inc. (California, USA), under cGMP conditions for Ananda Therapeutics. Ananda will supply Nantheia ATL5 Softgel Capsules and matching placebo for this study. Capsules will be administered orally as indicated below. Ananda Therapeutics is FDA-approved to supply this product. Dosage and Duration of Treatment: This study will evaluate Nantheia ATL5 in participants given CBD or placebo (1:1). The treatment period will be 56 days (8 weeks). Participants will be in the study for up to 24 weeks, including follow-up at 1 and 3 months after completion of the treatment protocol. The CBD/placebo dose will be 800 mg/day. Dose Justification: A daily dose of 600 mg is being evaluated in our ongoing trial of CBD for opioid use disorder (ClinicalTrials.gov Identifier: NCT03787628). Doses of CBD as high as 50 mg/kg (i.e., 3500 mg for a 70-kg participant) were well tolerated; and doses between 300 and 1500 mg have been used in humans without serious adverse events. Forty-two subjects received 200 mg of CBD 4x daily (total 800 mg per day) for 2-4 weeks to treat schizophrenia without notable side effects. Additionally, a review of 132 reports including animal and human studies concluded that CBD was well-tolerated in humans, at doses of up to 1500 mg/day. Regulatory Considerations: CBD will be administered in this protocol as Nantheia ATL5, a hemp-derived product that contains < 0.3% tetrahydrocannabinol (THC). Nantheia ATL5 is not a Schedule 1 controlled substance because Nantheia ATL5 is hemp-derived CBD with a THC concentration of no more than 0.3%. The investigators have obtained FDA approval for this project. The investigators will receive oversight and obtain approval from the UCLA Institutional Review Board. Receipt and Storage of the Investigational Product (IP). The IP will be delivered by the manufacturer in bottles containing 28 1-mL softgels each for testing of 800 mg CBD vs. placebo. Nantheia ATL5 will be stored at room temperature, 59-86°F (15-30°C), in a locked cabinet in a locked office of a staff member blinded to its identity (CBD or placebo). Dispensation of the IP: Staff not involved in data entry or any other aspects of the study will distribute the IP into containers labeled with the subject-ID number and/or patient initials and doses will be divided for AM or PM. The investigational product (CBD or placebo) will be taken under staff supervision at the CRI-Help treatment center. A Residential Technician (RADT) will be responsible for supervising and recording patient's self-administration of the IP. Unused or missed medication will be collected once weekly and prepared for return to the manufacturer.
Phase
2Span
113 weeksSponsor
University of California, Los AngelesNorth Hollywood, California
Recruiting
Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
Double-blind, randomized, placebo-controlled, multi-center study of metaxalone 640 mg plus standard of care for patients with acute lumbo sacral musculoskeletal conditions with spinal stenosis and sciatica. Participants will be randomized 1:1. Following the initial pilot-study a second study will randomize a larger population of patients with appropriate power.
Phase
4Span
105 weeksSponsor
Primus PharmaceuticalsValley Village, California
Recruiting
Healthy Volunteers
A Phase 3B Study to Evaluate Bone Mineral Density with Long-Term Use of Relugolix Combination Tablet in Women with Uterine Fibroids or Endometriosis
A prospective, single-arm, open-label, Phase 3B study to assess the effect of continuous 48 months (4 years) of treatment with relugolix combination tablet (relugolix 40 mg/estradiol [E2] 1 mg/norethindrone acetate [NETA] 0.5 mg) on bone mineral density in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) and premenopausal women with moderate to severe pain associated with endometriosis. Approximately 1000 women (500 with heavy menstrual bleeding associated with uterine fibroids and 500 with moderate to severe pain associated with endometriosis) will receive relugolix combination tablet, during which time BMD will be assessed by dual-energy X-ray absorptiometry every 6 months. A subset of participants will be eligible to enter this study following completion of 1 year of treatment with relugolix combination therapy in MVT-601-050 (NCT04756037; SERENE) and will complete 3 years of treatment under this protocol. Upon completion of 48 months (4 years) of treatment or after early termination of treatment, participants will enter a 1-year post-treatment follow-up period during which time bone mineral density will be assessed at Month 6 and Month 12 following treatment cessation.
Phase
3Span
372 weeksSponsor
Sumitomo Pharma Switzerland GmbHValley Village, California
Recruiting
A Pivotal Study to Evaluate the Effectiveness of Isometric Handgrip Therapy in Elevated Blood Pressure and Hypertensive Subjects
Study subjects randomized to the Zona Plus Device arm will perform isometric therapy with the device with subject compliance monitored through a downloadable electronic memory function built into the device. Study subjects randomized to the control arm will be asked to listen to relaxing music via a mobile app and asked to document their compliance via a patient diary. Subjects in the control arm may be able to crossover to using the Zona Plus device after completion of Study Visit 6. Subjects who have systolic blood pressure between 140mmHG and 149mmHG at baseline will complete three additional study visits for further monitoring. Subjects can expect participation in the study to last between 3 and 8 months.
Phase
N/ASpan
114 weeksSponsor
Zona Health, IncValley Village, California
Recruiting
Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults.
Phase
3Span
250 weeksSponsor
PfizerNorth Hollywood, California
Recruiting
Healthy Volunteers
Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
Phase
2Span
158 weeksSponsor
SanofiNorth Hollywood, California
Recruiting
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
Phase
3Span
376 weeksSponsor
Boehringer IngelheimNorth Hollywood, California
Recruiting
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Phase
3Span
483 weeksSponsor
PfizerNorth Hollywood, California
Recruiting
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Phase
3Span
417 weeksSponsor
PfizerNorth Hollywood, California
Recruiting
Clinical Specimen Collection From Pompe Disease Patients
This protocol is to collect blood and HSPC specimens from individuals with Pompe Disease. The first blood draw will be done at the first study visit and if eligible, the second collection will be done via mobilized leukapheresis at the second visit. The mobilized leukapheresis procedures will follow the facility's standard operating procedures and protocol requirements for mobilized leukapheresis. Donors will be males or females between and including the ages of 3 years and 30 years. Volunteers will provide written informed consent and meet all inclusion and exclusion criteria. Each participant can be in the study for up to 120 days (3 months). The study will be conducted in accordance with human research for the purposes of obtaining clinical specimens for research. There is no endpoint for this study, however, data collected from this study will include, but not be limited to, gender, demographics, medical history, clinical laboratory values, and volume of the blood collected. The data will be summarized in future studies reporting results from a future clinical trial under FDA IND.
Phase
N/ASpan
39 weeksSponsor
Serhat Gumrukcu, MD PhDToluca Lake, California
Recruiting