Clinical Trials - Drug Trials For Money

Informing Oral Nicotine Pouch Regulations to Promote Public Health

NCT ID: NCT06315881

Study Summary

This clinical trial evaluates the characteristics of oral nicotine pouches (ONPs) to determine if they are a comparable substitute to cigarette or smokeless tobacco (ST) products. ONPs contain nicotine but no tobacco and are used primarily by adult tobacco uses in the United States (US). ONPs are recognized by the Food and Drug Administration as having lower risk than combustible cigarettes and are approved as a modified risk tobacco product. While ONPs have lower toxic risk than other tobacco products, acute and longer term harm related to their use has not been studied. Information gathered from this study may identify product characteristics of ONPs that improve successful switching from high-risk cigarettes or ST to lower risk ONPs.

Eligibility Requirements

Inclusion Criteria:
* Read and speak English
* At least 21 years old
* Willing to provide informed consent and abstain from all tobacco, nicotine, and marijuana use for at least 12 hours prior to Phase 1 study visits
* Willing to attend all study visits and use study ONPs
* Owns a smartphone and able to receive short messaging service (SMS) text messages with embedded survey link (for daily diary reports of ONP and other tobacco use)
* Negative pregnancy test produced during Phase 1 visits 1-5 and Phase 2 visit 1 if capable of becoming pregnant
* Exhaled carbon monoxide (CO) reading < 10 (Phase 1)
* CIGARETTE SMOKERS ONLY: Established cigarette smoker (has smoked at least 100 cigarettes, has smoked daily for at least the past 3 months, now smokes at least 5 cigarettes per day)
* ST USERS ONLY: Established moist snuff user (has used moist snuff daily for at least the past 3 months, uses at least 1.5 cans/week (as in Pickworth et al., 2014)
Exclusion Criteria:
* Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
* History of cardiac event or distress within the past 3 months
* Currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test before each Phase 1 study visit [acute use of usual product and study ONPs] and Phase 2 study visit 1 [distribution of study ONPs for outpatient ad libitum use])
* Currently engaging in tobacco quit attempt, interested in quitting all tobacco, or planning on quitting all tobacco in the next 3 months
* Oral or systemic health issues that affect oral microbiome or epithelium, including having fewer than 21 teeth, diabetes mellitus, or autoimmune disease (e.g., rheumatoid arthritis, lupus)
* CIGARETTE SMOKERS ONLY: Use of non-cigarette tobacco products ≥ 10 of the past 30 days
* CIGARETTE SMOKERS ONLY: Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, or chronic obstructive pulmonary disease
* CIGARETTE SMOKERS ONLY: Roll-your-own cigarette smokers
* ST USERS ONLY: Use of non-moist-snuff tobacco products ≥ 10 of the past 30 days

View full study details and apply: https://clinicaltrials.gov/study/NCT06315881

April 28, 2026DrugTrialsForMoney.comComments OffClinical TrialsColumbus | Ohio | Tobacco-Related Carcinoma

A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes

NCT ID: NCT07262788

Study Summary

The overall aim of this study is to examine the feasibility of a 12-month, two-arm lifestyle intervention to induce and maintain remission of type 2 diabetes (T2D). The findings from the feasibility study will inform the recruitment, design and delivery of the interventions in a 5-arm, 24-month randomised controlled trial.

Eligibility Requirements

Building on previous findings from T2D remission studies involving VLCD interventions, the study include individuals with recently diagnosed T2D who are overweight or obese and not receiving insulin therapy. This subgroup has demonstrated the greatest benefit from significant weight loss. Participants using GLP-1 receptor agonists (GLP-1 RAs) are eligible, provided their weight has been stable for at least three months prior to inclusion. Individuals on insulin therapy will be excluded. Allowing GLP-1 RA use enhances the study's generalizability, as approximately 29% of people with T2D in Denmark are currently treated with these medications.
Inclusion Criteria:
* Diagnosis of T2D. Treatment lifestyle changes, oral anti-diabetic medication including metformin, and/or sulfonylureas and/or DPP-4 inhibitors and/or SGLT2 inhibitors and/or incretin-based medication
* HbA1c between 36-86 mmol/mol
* T2D duration of ≤6 years
* BMI ≥27 kg/m2
* Body weight changes over 3 months ≤3 kg
Exclusion Criteria:
* Insulin treatment within 6 months prior to screening (any type)
* Heart failure (ejection fraction ≤40%) and treated with SGLT-2i (current or planned)
* Cardiovascular disease, including previous heart attack or stroke, for which incretin-based therapy and/or an SGLT-2i has been prescribed.
* Kidney disease (eGFR <60 ml/min/1,73m² and/or albuminuria (≥30 mg/g) for at least three months) and treated with SGLT-2i (current or planned)
* Physical comorbidity, which precludes the physical activity during intervention
* Dietary restrictions or allergies making the participant unable to adhere to the dietary interventions
* Unable to comply with trial procedures and/or interventions
* Alcohol/drug abuse
* Planned or present pregnancy/fertility treatment, or lack of contraception during reproductive age
* Unstable psychiatric disease that is deemed to impede participation in the project
* Diagnosed with binge eating disorder
* Participation (present or planned) in other clinical trials including lifestyle or pharmacy trials for any condition
* If HbA1c ≥60 mmol/mol and the participant is on 2 or more anti-diabetic drugs and has a positive GAD65 and/or stimulated C-peptide <800 pM

View full study details and apply: https://clinicaltrials.gov/study/NCT07262788

April 25, 2026DrugTrialsForMoney.comComments OffClinical TrialsDenmark | Herlev | Type 2 Diabetes

Single Versus Dual Implant Fixation of Distal Femur Fractures

NCT ID: NCT06286670

Study Summary

The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities.

Eligibility Requirements

Inclusion Criteria:
* Age greater than or equal to 18 years
* Surgically treated displaced distal femur extra articular or complete articular fractures
Exclusion Criteria:
* Patients with injury features that preclude treatment with 2 implants
* Patients unlikely to follow-up due to homelessness, or planning follow up at another institution
* Body Mass Index (BMI) > 40
* Injury due to ground level fall
* Patient that speaks neither English or Spanish
* Patients with multisystem injuries that could preclude return to work
* < 18 years of age
* Prisoner

View full study details and apply: https://clinicaltrials.gov/study/NCT06286670

Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis

NCT ID: NCT04518657

Study Summary

We propose a highly-informed, well-designed randomized controlled trial (RCT) that is critical for providing Class I evidence regarding an Internet-delivered physical activity (PA) intervention as a behavioral approach for managing slowed cognitive processing speed (CPS; the most common and perhaps most burdensome MS-related cognitive impairment) and its second learning and memory, symptomatic, and quality of life (QOL) correlates among fully-ambulatory persons with multiple sclerosis (MS) who present with CPS impairment. Such an approach will involve a single-blind, RCT that examines the effects of a remotely-delivered, Internet-based PA intervention compared with an active control condition for yielding immediate and sustained improvements in CPS, learning and memory, symptomatic, and QOL outcomes among persons with mild MS-related ambulatory impairment who demonstrate impaired CPS. The primary outcome is the raw (unadjusted), oral Symbol Digit Modalities Test (SDMT) score as a neuropsychological measure of CPS, and this will be collected remotely via screen-sharing technology. The secondary outcomes include an objective neuropsychological measure of learning and memory (California Verbal Learning Test-II) collected remotely via screen-sharing technology, self-report measures of fatigue (Fatigue Severity Scale), depressive symptoms and anxiety (Hospital Anxiety and Depression Scale), pain (Short-Form, McGill Pain Questionnaire) and QOL (Multiple Sclerosis Impact Scale-29) that will be captured remotely using Qualtrics. The tertiary outcome is accelerometry as an objective, device-based measure of steps/day that will be delivered and returned via pre-paid, pre-addressed envelopes through the United States Postal Service for generating a minimal clinically important difference value that guides the prescription of free-living PA for managing CPS impairment in clinical practice.

Eligibility Requirements

Inclusion Criteria:
* Residing in the United States (residing in Alabama is not required)
* English as primary language
* Between 18+ years old
* Diagnosis of MS
* Relapse free in the past 30 days
* Internet and email access
* Currently physically inactive (GLTEQ)
* Able to ambulate without assistance (self-report and PDDS)
* Willingness to complete the questionnaires
* Willingness to wear the accelerometer
* Willingness to undergo random assignment (BIPAMS or WellMS)
Exclusion Criteria:
* Individuals not meeting above inclusion criteria
* Individuals with moderate to high risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise (PARQ)

View full study details and apply: https://clinicaltrials.gov/study/NCT04518657

April 25, 2026DrugTrialsForMoney.comComments OffClinical TrialsChicago | Illinois | Multiple Sclerosis

Addressing Diabetes by Elevating Access to Nutrition

NCT ID: NCT05228860

Study Summary

The goal of ADELANTE is to determine whether a multi-level intervention to improve household food insecurity and glycemic control is effective for Latino patients with diabetes.

Specifically, ADELANTE aims to

1. determine whether weekly household food delivery plus an intensive lifestyle intervention is more effective than usual care for improving glycemic control (HbA1c) at 6 months,
2. examine the effects of the multi-level intervention on = household food insecurity, dietary behaviors, and psychosocial outcomes, and
3. assess the future potential for implementation and dissemination of this multi-level intervention in primary care settings.

Eligibility Requirements

Inclusion Criteria:
* For main study (index/intervention) participants:
  * Age at enrollment: 18+ years
  * Self-identified ethnicity: Hispanic, Latino, Chicano, or Spanish
  * Type 2 diabetes indicated in the electronic health record, e.g. as ICD-10 (International Classification of Diseases) diagnosis code or HbA1c value
  * Have indicated food insecurity according to the screening 2-item Hunger Vital Sign questionnaire
  * Have a Body Mass Index (BMI) => 25
  * Receiving care at our partnering community health centers (e.g., Clinica de la Raza)
  * Currently residing in Alameda or Contra Costa County and not expecting to relocate in the next 6-12 months
  * Have access to phone or computer, email, and some internet for access to remote intervention and completion of follow-up measures
* For household members:
  * Age at enrollment: 12+ years
  * Significantly involved in supporting nutrition in the home including food shopping, preparation, social support for healthy nutrition
  * Willing to complete some questionnaires and attend a single group session.
* For all participants:
  * Able and willing to provide informed consent
Exclusion Criteria:
* Unable to provide informed consent
* Unable to speak, read, or understand English and/or Spanish
* Active substance use or psychotic disorders that would impair participation in a group lifestyle intervention or interfere with follow-up assessments
* Lacking mailing address for delivery of food box
* Planning to relocate out of area within the next 12 months
* Index participant only: Pregnant or planning to become pregnant within the next 12 months

View full study details and apply: https://clinicaltrials.gov/study/NCT05228860

April 25, 2026DrugTrialsForMoney.comComments OffClinical TrialsCalifornia | Concord | Diabetes | Lifestyle, Healthy | Obesity

Improving Walking Performance in Patients With Peripheral Artery Disease Through Wearable Activity Trackers

NCT ID: NCT07012070

Study Summary

Peripheral Arterial Disease (PAD) of the lower extremities is common and prevalence of PAD is increasing in our aging population. The presence of PAD is associated with increased cardiovascular morbidity and mortality, reduced physical function and quality of life.

Intermittent claudication is the most common symptom of PAD affecting about 30% of the patients. Supervised exercise therapy (SET) is safe and cost-effective therapy when compared with invasive revascularization, and is recommended as the first-line treatment for symptomatic PAD. However, SET is not readily available in the public healthcare system.

Barriers to SET implementation include demands for healthcare resources and the inconvenience of travelling to designated centre for SET. Home-based exercise therapy (HBET) has been proposed as an alternative to SET as they are more accessible and more acceptable to patients, but the benefits of HBET compared to SET have not been consistently demonstrated in studies. Wearable activities monitor (WAM) have been proposed as an adjuvant to enhance the performance of HBET. However, there is no direct comparison of WAM enhanced HBET to SET. Furthermore, WAMs were mainly used for monitoring in HBET in the previous studies and patient feedback was conducted either in-person or over telephones by the researchers, which challenges the true meaning of HBET. In this study, we aim to evaluate the non-inferiority of personalized self-guided HBET enhanced with WAM and auto feedback mobile apps, to SET, in a randomized-controlled trial of patients with symptomatic PAD.

Eligibility Requirements

Inclusion Criteria:
1. Patients who are newly diagnosed with symptomatic claudication as defined by the presence of claudication symptoms elicited by the single claudication question
2. Patients who ABI <0.9 are the primary target population
Exclusion Criteria:
1. Patients is inability to ambulate without walking aids or understand the instruction of exercise
2. Patients have history of previous percutaneous or surgical revascularization of lower limb
3. Patients is presence of critical limb ischemia or gangrene
4. Patients has history of major amputation of the lower limb
5. Patients is presence of other co-morbidities which limit walking ability
6. Patients is presence of cardiovascular instability which includes unstable angina or acute coronary syndrome
7. Patients diagnosed active class III/IV heart failure
8. Patients is inability to operate simple electronic devices
9. Patients is inaccessibility of a mobile network service in the place of residence
10. Patients is unwillingness in sharing individual data to study team
11. Patients is life-expectance less than 6 months

View full study details and apply: https://clinicaltrials.gov/study/NCT07012070

April 25, 2026DrugTrialsForMoney.comComments OffClinical TrialsHong Kong | Peripheral Artery Disease | Shatin

Studying the Neurobiological Mechanisms of Non-specific Chronic Low Back Pain and Chronic Insomnia: a Four-group Cross-sectional Study

NCT ID: NCT06973837

Study Summary

This study is a part of a larger project aiming to evaluate the neurobiological mechanisms underlying the relationship between sleep and pain in people with non-specific chronic low back pain. Specifically, this study aims to evaluate the neurobiological mechanisms underlying the relationship between chronic sleep disturbances and pain sensitivity in people with non-specific chronic low back pain and chronic insomnia.

Eligibility Requirements

General inclusion criteria (all groups):
* 18-60 years old.
* Ability to speak and understand the Dutch Language.
* Body mass index <30.
* No smoking or nicotine use.
* Low caffeine use (≤3 cups of coffee/day, ≤1 energy drink/day).
* Low alcohol use (≤9 alcoholic units/week).
* No use of neuro- and/or psychopharmacological treatments and/or immunosuppressive agents (including NSAIDs) with a suspected influence on neuroinflammation unless terminated within a sufficient time frame before the start of the study, or unless falling under the Pharmacological exceptions criteria (see below).
* Willing to (try to) adhere to the acute pre-test restrictions, including refraining from analgesics (unless stable use), caffeine, alcohol, and/or strenuous physical activity (>3 METs) in the 24 hours preceding the main test day.
General exclusion criteria (all groups):
* Shift worker.
* Use of blood thinners.
* (History of) Substance dependence/abuse.
* Chronic pain conditions (≥3 months) other than chronic low back pain.
* Severe intrinsic sleep disorders (assessed during a one-night, laboratory-based polysomnography).
* Restless leg syndrome
* Central or peripheral neurological disorder/condition (e.g., epilepsy, multiple sclerosis, peripheral neuropathy).
* History of spinal surgery.
* Major medical (e.g., cardiac disease, cancer) and/or psychiatric disorder/disease (e.g., major depressive disorder, bipolar disorder).
* Claustrophobia.
* Contraindications for magnetic resonance imaging (e.g., metal/cochlear implants, pacemaker).
* Pregnancy or being <12 months post-natal.
Pharmacological exceptions criteria:
- Participants with chronic low back pain and/or (comorbid) insomnia will be allowed to be on a stable low dose of weak pain and/or sleep agents (e.g., Tramadol, Zolpidem) if medically prescribed specifically for their low back pain and/or insomnia, and if approved by the national medicine register of Belgium (FAMHP, Federal Agency for Medicine and Health Products). These participants will also be allowed stable and/or occasional use of low-to-moderate doses of over-the-counter medications for pain and/or sleep that are suspected to have no or minimal impact on neuroinflammation (e.g., paracetamol, melatonin). Habitual use of medications according to the above-stated criteria should be maintained across the entire study period, with the only exception being analgesics taken on an occasional basis. Specifically, because of the extensive battery of pain tests that will be utilized in the study, all analgesics that are only taken occasionally should be refrained from during the 24 hours preceding the main test day (pre-test instructions).
Specific inclusion criteria for "pain-free" groups:
* Currently pain free, defined as having no pain that affects daily living/functioning and/or which has led to a consultation with a healthcare practitioner.
* No episode of low back pain that interfered with daily functioning/living and/or which led to a consultation with a healthcare practitioner within 12 months from the time of inclusion.
* No history of chronic low back pain.
Specific inclusion criteria for "chronic low back pain" groups:
* Low back pain reported on most days (≥50%), every week, for more than 3 months.
* Low back pain-related emotional disress OR functional disability rated as ≥3 out of 10.
Specific inclusion criteria for "good sleeper" groups:
* Stable sleep phase within 10 PM and 10 AM (assessed using the Pittsburgh Sleep Quality Index).
* Average habitual total sleep time between 7 and 9 hours (assessed using the Pittsburgh Sleep Quality Index).
* A Pittsburgh Sleep Quality Index ≤5.
* An Insomnia Severity Index ≤7.
* An Epworth Sleepiness Scale ≤10.
* Sleep efficiency ≥85% during a one-night, laboratory-based polysomnography screening.
* No episode of sleep disturbances that interfered with daily functioning/living and/or which led to a consultation with a healthcare practitioner within the preceding 12 months from the time of inclusion.
* No history of chronic insomnia.
Specific inclusion criteria for "chronic insomnia" groups:
* Chronic insomnia according to the ICSD-3-TR criteria (assessed using an ICSD-3-TR-adapted version of the Pittsburgh Sleep Quality Index).
* An Insomnia Severity Index ≥15.

View full study details and apply: https://clinicaltrials.gov/study/NCT06973837

April 25, 2026DrugTrialsForMoney.comComments OffClinical TrialsChronic Insomnia | Chronic Low Back Pain (CLBP) | Leuven | Neuroinflammation

Use of a Cloud-connected Remote Blood Pressure Monitoring Program During the Postpartum Period for Hypertensive Women

NCT ID: NCT06096701

Study Summary

Hypertensive disorders (HD), including preeclampsia, gestational hypertension, chronic hypertension, and chronic hypertension with superimposed preeclampsia, affect around 10-20% of pregnant women in the United States and are significantly associated with maternal mortality and morbidity, particularly in the postpartum period. The prevalence of HD is on the rise in the United States and has increased from 13% in 2017 to 16% in 2019 owing to an increase in advanced maternal age, obesity, and diabetes. There are major racial disparities in HD and subsequent maternal mortality and morbidity. HD affect more than 1 in 5 delivery hospitalizations of Black women. Black women with HD are also more likely than white women with HD to have more adverse postpartum blood pressure trajectories which leads to a higher incidence of hypertension related hospital readmissions (readmission for hypertension during the first 6-weeks postpartum: 16.9% among Black women vs. 9.5% among white women, p=0.02) and cardiovascular-related adverse events. However, most of the management recommendations have been centered around blood pressure targets during the antepartum period with significantly less attention paid to the postpartum period despite evidence showing that hypertensive disorders are the most common reason for postpartum readmissions and are associated with increased maternal mortality and morbidity and a significant cost burden.

Eligibility Requirements

Inclusion Criteria:
* Pregnant individuals with hypertensive disorders
* Speak English
* At least 18 years old
* Medicaid coverage
* Between 20 weeks of pregnancy and 2 weeks postpartum
* Postpartum admission at Prisma Health Richland with hypertensive disorder within 2 weeks postpartum
Exclusion Criteria:
* Not planning to deliver at Prisma Health Richland
* Less than 20 weeks of pregnancy
* More than 2 weeks postpartum

View full study details and apply: https://clinicaltrials.gov/study/NCT06096701

April 25, 2026DrugTrialsForMoney.comComments OffClinical TrialsColumbia | Hypertensive Disorder | South Carolina

Groceries for Residents of Southeastern USA to Stop Hypertension

NCT ID: NCT06891911

Study Summary

GoFreshSE is a randomized control trial, testing the effects of a home-delivered, dietitian-assisted, DASH-patterned grocery intervention on blood pressure in adults with high blood pressure in Florida, Georgia, and Tennessee.

Eligibility Requirements

Inclusion Criteria:
1. Resting systolic blood pressure of 120 to <160 mm Hg and diastolic blood pressure <110 mm Hg
2. Resident of Florida, Georgia, and Tennessee
3. Able to receive home-delivered groceries or pick them up at a convenient location and willing to eat only the groceries provided over a 4-week period
4. Have access to refrigeration, cooking appliances, and Wi-Fi/cellular service
5. Have access to mobile device or computer to be able to conduct grocery orders via video conference and send/receive text messages
6. Willing and able to complete required measurement procedures
7. Able to provide consent for the study
8. Has access to a primary care team, urgent care center, or emergency room the study team can refer to for follow up care if warranted during the study
Exclusion Criteria:
A. Laboratory Exclusions:
1. Serum potassium ≥5.0 mmol/L or <3.5 mmol/L
2. Estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73 m^2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
3. Hemoglobin A1c ≥6.5%
B. Medication Exclusions:
Unstable doses (i.e. a change in the 6 months prior to screening or randomization or planning to start within study period) of the following:
1. GLP-1 and dual GLP-1/GIP receptor agonists
2. Anti-hypertension medications
3. Sodium-glucose co-transporter 2 (SGLT2) inhibitors
4. Glucose lowering medications
Use of any of the following medications:
1. Potassium supplement, except if part of a multivitamin
2. Warfarin (Coumadin)
3. Chronic oral corticosteroid (intermittent use is okay)
4. Weight loss medications (non-GLP-1 receptor agonists)
5. Sulfonylurea or any insulin use
Any medication not compatible with participation as determined by the investigators
C. Physical Exclusions:
1. Systolic blood pressure: <120 or ≥160 mm Hg or diastolic blood pressure ≥110 mm Hg
2. Arm circumference >52 cm (or the upper limit of the validated BP device)
D. Medical History Exclusions:
1. Self-reported weight loss or gain of 15 pounds during prior 2 months
2. Active cardiovascular disease or any event in the prior 6 months, including coronary artery bypass grafting (CABG), percutaneous transluminal coronary angioplasty (PTCA), myocardial infarction (MI), cerebrovascular accident (CVA), or congestive heart failure (CHF) exacerbation requiring hospital admission
3. Cancer diagnosis or treatment in the last 2 years (non-melanoma skin cancer or localized breast or prostate or bladder cancer not requiring systemic therapy is acceptable)
4. Gastrointestinal surgery or history that affects nutrition absorption or requires a specific diet that will deter DASH diet adherence
5. Pregnancy or lactation or planned pregnancy during the study period
6. Any emergency department (ED) visit for asthma or chronic obstructive pulmonary disease (COPD) in the last 6 months
7. Hypoglycemia hospitalization in the last 12 months
8. Any other serious illness or condition not compatible with participation as determined by the investigators
E. Lifestyle and Other Exclusions:
1. Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence
2. Consumption of more than 14 alcoholic drinks per week or consumption of more than 6 drinks on one or more occasion per week
3. Active substance use disorder that would interfere with participation
4. Extreme food insecurity
5. Participation in or planning to start weight loss program
6. Current participation in another clinical trial that could interfere with the study protocol
7. Anticipated change in residence outside of eligible states prior to the end of the study
8. Families with more than 6 adults at dinner time (children count as half an adult)
F. Investigator discretion

View full study details and apply: https://clinicaltrials.gov/study/NCT06891911

Growing Strong Study of Unconditional Cash Transfers Plus Peer Support for Families With Babies in Homeless Shelters

NCT ID: NCT06323967

Study Summary

The Growing Strong program tests a novel approach to helping families with young children living in homeless shelters, namely offering guaranteed, unconditional cash gifts that families can use as they wish plus voluntary peer support. The assumption behind this approach is that families know best how to allocate resources to meet their own individual needs. While there are a number of Direct Cash Transfer studies taking place around the country, the investigator(s) are unaware of any that have tested the relationship of receiving cash on homelessness among families specifically. To be eligible to participate in the study, families must reside in a homeless shelter and have at least one child under two years of age living with them in shelter. The investigator(s) have tied eligibility to the age of the youngest child in the household because rates of shelter use are highest among this population and because the costs associated with young children increase such families’ financial burdens.

A total of 200 families will be enrolled in the study. One hundred families in the active intervention group will receive $1,500 per month (“substantial cash”) for 24 months ($18,000 annually) and may also elect to receive peer support services. One hundred families in the active comparison group will receive $50 per month (“nominal cash”) for 24 months ($600 annually) and will not have access to the peer support services. A third, passive comparison group will receive usual care within the homeless shelter system in the same metropolitan area (New York City) as participants in both cash gift groups. This group of families will be followed only in administrative records.

The main research questions are: does providing substantial, unconditional cash transfers plus access to voluntary peer support services over 24 months a) reduce the length of time in shelter for families with young children and/or b) improve other aspects of family and child well-being relative to providing nominal cash transfers alone or usual care.

Eligibility Requirements

Note that New York City has a right to shelter. When a family applies for shelter, the City assigns them to a shelter temporarily while City workers determine whether the family is truly homeless. If so, the City will deem the family "eligible" for shelter. If not, the family must leave.
Inclusion Criteria:
* A family has been found "eligible" for shelter (as described above) within the past 30 days
* The family has a baby who meets the age criteria (under 2 years of age)
* There is an adult 18 or over who has custody of the child (typically the mother)
* The family speaks English or Spanish
* The family lives in a designated Win shelter
Exclusion Criteria:
* None: any family configuration is permissible

View full study details and apply: https://clinicaltrials.gov/study/NCT06323967

April 25, 2026DrugTrialsForMoney.comComments OffClinical TrialsChild Well-being | Family Well-being | New York | Time to Shelter Exit