Syndros

Acquired Immunodeficiency Syndrome, Obesity, Pharmacotherapy + 2 more

Treatment

20 Active Studies for Syndros

What is Syndros

Dronabinol

The Generic name of this drug

Treatment Summary

Dronabinol (also known as Marinol) is a synthetic form of THC, the active ingredient in marijuana. It affects the body by binding to certain receptors, which can result in increased appetite, reduced pain, and altered cognitive processes. It is commonly prescribed to treat anorexia in people with AIDS and to help reduce nausea and vomiting caused by cancer treatments. It is also used to activate THC and CBD, which are two compounds found in marijuana that have medicinal properties. THC and CBD interact with receptors found throughout the body, and are believed to help with a wide range of medical conditions including inflammation, cardiovascular function, learning, pain

Dronabinol

is the brand name

image of different drug pills on a surface

Syndros Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Dronabinol

Dronabinol

1994

62

Effectiveness

How Syndros Affects Patients

Dronabinol may cause an increased heart rate and redness around the eyes. Its effects on blood pressure vary, but some people have experienced lightheadedness when they stand up too quickly. It can also affect mood, thinking, memory, and senses, and these effects may become stronger with higher doses. After taking it orally, the drug usually takes effect within half an hour to an hour, with its peak effect between 2 to 4 hours. Its psychoactive effects can last for 4 to 6 hours, and its appetite stimulant effect may last for up to 24 hours. With long-term use, people may develop tolerance to its

How Syndros works in the body

Dronabinol is a synthetic version of the chemical found in cannabis (marijuana) that causes its psychological effects. This chemical, Delta-9-tetrahydrocannabinol (Δ⁹-THC), affects the body by activating specific receptors, called CB1R and CB2R, that cause changes in appetite, reduce pain and alter emotional and cognitive processes.

When to interrupt dosage

The proposed dosage of Syndros is contingent upon the diagnosed condition, including Unintentional Weight Loss, Pharmacotherapy and Acquired Immunodeficiency Syndrome. The extent of dosage is subject to the administration strategy (e.g. Buccal or Capsule - Oral) presented in the table below.

Condition

Dosage

Administration

Pharmacotherapy

, 2.5 mg, 10.0 mg, 5.0 mg, 5.0 mg/mL, 2.7 mg/pump actuation

, Capsule, liquid filled - Oral, Capsule, liquid filled, Oral, Capsule, Solution - Oral, Solution, Capsule - Oral, Spray - Buccal, Spray, Buccal

Anorexia

, 2.5 mg, 10.0 mg, 5.0 mg, 5.0 mg/mL, 2.7 mg/pump actuation

, Capsule, liquid filled - Oral, Capsule, liquid filled, Oral, Capsule, Solution - Oral, Solution, Capsule - Oral, Spray - Buccal, Spray, Buccal

Acquired Immunodeficiency Syndrome

, 2.5 mg, 10.0 mg, 5.0 mg, 5.0 mg/mL, 2.7 mg/pump actuation

, Capsule, liquid filled - Oral, Capsule, liquid filled, Oral, Capsule, Solution - Oral, Solution, Capsule - Oral, Spray - Buccal, Spray, Buccal

Obesity

, 2.5 mg, 10.0 mg, 5.0 mg, 5.0 mg/mL, 2.7 mg/pump actuation

, Capsule, liquid filled - Oral, Capsule, liquid filled, Oral, Capsule, Solution - Oral, Solution, Capsule - Oral, Spray - Buccal, Spray, Buccal

Disease

, 2.5 mg, 10.0 mg, 5.0 mg, 5.0 mg/mL, 2.7 mg/pump actuation

, Capsule, liquid filled - Oral, Capsule, liquid filled, Oral, Capsule, Solution - Oral, Solution, Capsule - Oral, Spray - Buccal, Spray, Buccal

Warnings

Syndros Contraindications

Condition

Risk Level

Notes

Pulse Frequency

Do Not Combine

There are 20 known major drug interactions with Syndros.

Common Syndros Drug Interactions

Drug Name

Risk Level

Description

Acenocoumarol

Major

The metabolism of Acenocoumarol can be decreased when combined with Dronabinol.

Aminophylline

Major

The metabolism of Aminophylline can be decreased when combined with Dronabinol.

Anagrelide

Major

The metabolism of Anagrelide can be decreased when combined with Dronabinol.

Astemizole

Major

The metabolism of Astemizole can be decreased when combined with Dronabinol.

Axitinib

Major

The metabolism of Axitinib can be decreased when combined with Dronabinol.

Syndros Toxicity & Overdose Risk

SYNDROS, a synthetic cannabinoid with alcohol, may cause harm to a fetus. Pregnant women should not take SYNDROS. Although there is limited research on the effect of synthetic cannabinoids during pregnancy, using cannabis or alcohol during pregnancy has been known to cause negative outcomes for the baby. Breastfeeding mothers should also not take SYNDROS, as it can be passed to the baby and cause adverse reactions. SYNDROS has not been tested on children, and elderly patients may be more sensitive to its effects. Those taking SYNDROS may be at risk of addiction or experiencing psychosis, hallucinations, and paranoia

image of a doctor in a lab doing drug, clinical research

Syndros Novel Uses: Which Conditions Have a Clinical Trial Featuring Syndros?

137 active clinical trials are in progress to evaluate the potential of Syndros to provide Pharmacotherapy, counteract Unintentional Weight Loss and enhance response to conventional therapy.

Condition

Clinical Trials

Trial Phases

Disease

0 Actively Recruiting

Acquired Immunodeficiency Syndrome

4 Actively Recruiting

Phase 1, Phase 2, Not Applicable

Pharmacotherapy

1 Actively Recruiting

Not Applicable

Anorexia

1 Actively Recruiting

Phase 1

Obesity

42 Actively Recruiting

Phase 2, Phase 4, Not Applicable, Phase 3, Phase 1

Syndros Reviews: What are patients saying about Syndros?

4

Patient Review

11/14/2018

Syndros for Nausea and Vomiting caused by Cancer Drugs

This is an expensive but effective treatment for cancer patients undergoing chemotherapy. It alleviates both pain and nausea with minimal side effects.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about syndros

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Syndros available?

"The FDA has recently approved Syndros, a liquid form of synthetic cannabinoid dronabinol, for the treatment of cachexia and nausea and vomiting in AIDS and cancer patients, with the potential as a pain management agent."

Answered by AI

What is the difference between Syndros and Marinol?

"Syndros is a liquid version of Marinol (dronabinol), which is a soft gel capsule that contains tetrahydrocannabinol (THC), the primary active compound in cannabis (marijuana). Marinol is developed by AbbVie Inc. Syndicate is the first and only FDA-approved dronabinol solution that is meant to be taken orally."

Answered by AI

What schedule drug is Syndros?

"The DEA has announced that it has scheduled the newly approved synthetic THC-containing drug, Syndros, as a Class II substance."

Answered by AI

Is Syndros FDA-approved?

"The first and only FDA-approved medication containing tetrahydrocannabinol (THC) is SYNDROS. It is a liquid cannabinoid that is used in adults to treat nausea and vomiting caused by chemotherapy, in people who have not experienced relief from conventional anti-nausea medication."

Answered by AI

Clinical Trials for Syndros

Image of Los Angeles General Medical Center in Los Angeles, United States.

Decision Support Tool for HIV Treatment

18+
All Sexes
Los Angeles, CA

This study is testing software designed to help healthcare providers choose the best HIV treatment combinations for their patients. HIV medicines, known as antiretroviral therapy (ART), can be complex to manage because the right regimen depends on many factors-such as drug resistance, other health conditions, and medication schedules. Many people with HIV are cared for by general clinicians who may not have access to HIV specialists, which can make treatment decisions more challenging. In this study, healthcare providers will use patient cases to compare standard HIV treatment resources with a new clinical decision support tool that gives evidence-based ART recommendations at the point of care. The investigators hypothesize that using the tool will help providers select treatment plans that better match clinical guidelines, make decisions faster, reduce mental effort, and increase overall satisfaction with the prescribing process.

Waitlist Available
Has No Placebo

Los Angeles General Medical Center

Hayoun Lee, PhD

Image of Mayo Clinic in Rochester, United States.

Weight Loss Medications for Obesity in Bipolar Disorder

18 - 65
All Sexes
Rochester, MN

The goal of this clinical trial is to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss, and to study the effect of individualized guided medication in patients with bipolar disorder ages 18-65. The main questions it aims to answer are: * Can the investigators compare the distribution of obesity characteristics (hungry brain, hungry gut, emotional hunger) between bipolar patients and non-bipolar participants (comparing from IRB #24-002375)? * Can the investigators evaluate the feasibility of anti-obesity medication (AOM) in patients with bipolar disorder? Participation will last for about 17-18 weeks and includes 7 in-person study visits, 4 phone call visits, and 12 virtual group therapy sessions. The first visit lasts about 2 hours and includes going over the informed consent form, a diagnostic interview to confirm diagnosis, gathering vital signs, mood questionnaires, an ECG, and urine drug and pregnancy tests (if applicable). The second visit lasts about 6-7 hours and involves multiple procedures and completing questionnaires to determine which study drug would allow participants to lose weight most effectively. At the third visit, participants will be assigned to take one of three FDA approved medications for weight loss: Semaglutide (Wegovy®), Naltrexone/Bupropion (Contrave®), or Phentermine/Topiramate (Qysmia®). It is possible that participants could be assigned to a group that receives no study medication. All participants will be enrolled in a 12-week virtual group therapy program targeted for weight loss. On this third visit the investigators will also gather vital signs, and participants will give a sample of blood. After the third visit, participants will come in for study visits every 4 weeks for 16 weeks (4 visits) to assess medication adherence, vitals, and answer questions about mood and eating (participants will also give a sample of blood at the 8-week and 16-week visits). Every two weeks in between in-person visits, the study team will call participants to assess medication adherence. Participants will be compensated for time spent in this study.

Phase 4
Waitlist Available

Mayo Clinic

Mark A Frye, M.D.

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Image of Stanford University School of Medicine in Palo Alto, United States.

Dietary Strategies for Obesity

18+
All Sexes
Palo Alto, CA

The goal of the Reset trial is to learn about the optimal combination of dietary behavior strategies in a fully digital weight loss intervention. The intervention is designed for adults with overweight or obesity. The investigators will examine the impact on weight loss of four dietary strategies: 1) limiting Red Zone Foods (i.e., foods that are high in calories and low in nutrition), 2) limiting eating windows, 3) increasing protein intake, and 4) increasing fiber intake. Each of these strategies will include goal setting, daily self-monitoring, and tailored feedback. The investigators will recruit 208 participants. Broadly, adults with overweight or obesity who live in the U.S. will be eligible. The weight loss intervention will last 12 weeks. All participants will be asked to track their body weight daily and complete weekly behavioral lessons and action plans to promote healthy eating and physical activity. All study tasks will occur remotely. Assessment of body weight and survey measures will occur at the beginning of the trial ("baseline"), and at 1 month and 3 months. The Multiphase Optimization Strategy (MOST) framework will be used to identify which combination of the dietary behavior strategies results in the greatest weight loss. In total, there will be 16 treatment conditions.

Waitlist Available
Has No Placebo

Stanford University School of Medicine

Michele L Patel, PhD

Image of University of South Florida in Tampa, United States.

TORe + Lifestyle Changes for Weight Regain

18+
All Sexes
Tampa, FL

The goal of this clinical trial is to evaluate weight loss with TORe and intensive lifestyle modification versus intensive lifestyle modification alone in subjects who have regained weight following a Roux-en-Y gastric bypass. Participants will randomized 2:1. Those randomized to the TORe arm will receive a TORe procedure and intensive lifestyle modification which consists of a well-balanced calorie restrictive diet, incorporation of exercise and coaching on lifestyle discussion. Participants randomized the lifestyle modification alone arm will be eligible to receive a TORe procedure at 6 months post enrollment. Total follow up will be 24 months.

Waitlist Available
Has No Placebo

University of South Florida (+9 Sites)

Boston Scientific Corporation

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Image of Milken Institute School of Public Health - The George Washington University in Washington, United States.

Lifestyle Intervention vs Metformin for Gestational Diabetes

18 - 45
Female
Washington, United States

The goal of this clinical trial is to evaluate the effectiveness of a 6-month lifestyle intervention compared to Metformin in postpartum women who have delivered a singleton, live born infant within the last 12 weeks to 1 year and had a pregnancy complicated by gestational diabetes. The main question this study aims to answer is: Is a Lifestyle Intervention or Metformin more effective for weight loss in postpartum women with recent gestational diabetes? Researchers will compare a 6-month Lifestyle Intervention and Metformin to see if either intervention is more effective in achieving weight loss and improving health outcomes. Participants will: * Attend an in-person baseline visit to receive a Bluetooth-enabled scale and Fitbit, have blood drawn for testing, and have their height, weight, and blood pressure measured. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length. * Track diet, physical activity, and weight using the Fitbit and Looseit! apps. * Attend weekly online group sessions for the first 4 weeks, then biweekly sessions. * If not meeting weight loss goals, be randomized to either Enhanced Lifestyle Intervention or Metformin arms of the study. * If randomized to Metformin, participants will attend one in-person meeting with the study provider, get blood drawn for testing, and undergo a urine pregnancy test before starting the medication. * Continue with biweekly group sessions or have regular check-in calls. * If randomized to the Enhanced Lifestyle Intervention, participants will get a free Instacart membership, a 1:1 session with the study health counselor focused on meal planning and free grocery delivery once a week for the remainder of the study. * Participants will meet every other week via Zoom with the health counselor and other participants in the enhanced lifestyle arm. * At the end of the 6 months, all participants will come for an in-person visit to get blood drawn for testing. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length.

Phase 2
Recruiting

Milken Institute School of Public Health - The George Washington University (+1 Sites)

Wanda Nicholson, MD

Image of The Hospital for Sick Children in Toronto, Canada.

ML-Based Intervention for Vomiting in Pediatric Cancer

Any Age
All Sexes
Toronto, Canada

The goal of this single arm trial is to learn if a machine learning (ML) model predicting the risk of vomiting within the next 96 hours will impact vomiting outcomes in inpatient cancer pediatric patients. The main questions it aims to answer are whether an ML model predicting the risk of vomiting within the next 96 hours will: Primary 1\. Reduce the proportion with any vomiting within the 96-hour window Secondary 1. Reduce the number of vomiting episodes 2. Increase the proportion receiving care pathway-consistent care 3. Impact on number of administrations and costs of antiemetic medications Newly admitted participants will have a ML model predict the risk of vomiting within the next 96 hours according to their medical admission information. The prediction will be made at 8:30 AM following admission. Pharmacists will be charged with bringing information about patients' vomiting risk to the attention of the medical team and implementing interventions.

Recruiting
Has No Placebo

The Hospital for Sick Children

Santiago Arciniegas, MSc

Image of University of Texas Health Science Center at San Antonio in San Antonio, United States.

Tirzepatide for Muscle Health

18+
All Sexes
San Antonio, TX

Obesity and type 2 diabetes mellitus (T2DM) represent major public health concerns in the aging community. Tirzepatide, a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist recently approved for the treatment of T2DM and obesity has been shown to be effective at reducing weight, improving markers of T2DM control, and improving cardiovascular health. Utilization of tirzepatide among older adults has been on the rise since FDA approval was issued, however the effects of tirzepatide use on functional outcomes in older adults with obesity are not well established. Recent studies show that weight loss caused by tirzepatide may be driven by substantial loss of lean muscle mass, which may contribute to weakness and frailty, particularly among older adults. The proposed pilot study aims to evaluate how treatment with tirzepatide for 6 months affects muscle mass and function among older adults, and if changes in muscle mass are linked to changes in functional status over the same time period.

Phase 2
Waitlist Available

University of Texas Health Science Center at San Antonio

Elena Volpi, MD, PhD

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