You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR MARINOL


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Marinol

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00079560 ↗ Comparing the Effects of Smoked and Oral Marijuana in Individuals With HIV/AIDS Completed National Institute on Drug Abuse (NIDA) Phase 1/Phase 2 2001-12-01 Smoked marijuana (MJ) and dronabinol (also known as THC or by the trade name Marinol) are used to increase appetite, food intake, and weight in patients with HIV who experience unintended weight loss. This study will compare the effects of MJ and Marinol use in marijuana smokers who are HIV infected.
NCT00153192 ↗ Study to Evaluate the Efficacy of Dronabinol (Marinol) as Add-On Therapy for Patients on Opioids for Chronic Pain Completed Solvay Pharmaceuticals Phase 2/Phase 3 2001-04-01 The purpose of this research study is to determine if Marinol alleviates pain in patients with chronic pain who are currently taking opioids. The study begins with a 2-hour initial visit followed by three 8-hour appointments at Brigham and Women's Hospital. At each 8-hour visit, patients receive a dose of medication and complete surveys relating to pain. During the first visit a brief examination and a few surveys about pain, quality of life, and medical history are given. The study doctor then determines if the participant continues to qualify for the study. If qualified for the study, patients receive a daily diary to record pain levels and pain medications; this will take about 5 minutes each day. After completion of the diary, patients begin the 8-hour visits. Patients visit the Pain Trials Center three times to receive study medication. After taking the study medication, participants remain in the clinic for 8 hours to complete hourly surveys about pain and pain relief. Subsequent to these visits, patients may enter a 1-month extension where Marinol is taken at home, and pain levels are recorded in a diary. Participants can change the dose of study drug to better control pain and side effects, after speaking with study staff. The study then concludes with a final 30-minute visit to summarize the participant's experience in the clinical trial.
NCT00153192 ↗ Study to Evaluate the Efficacy of Dronabinol (Marinol) as Add-On Therapy for Patients on Opioids for Chronic Pain Completed Brigham and Women's Hospital Phase 2/Phase 3 2001-04-01 The purpose of this research study is to determine if Marinol alleviates pain in patients with chronic pain who are currently taking opioids. The study begins with a 2-hour initial visit followed by three 8-hour appointments at Brigham and Women's Hospital. At each 8-hour visit, patients receive a dose of medication and complete surveys relating to pain. During the first visit a brief examination and a few surveys about pain, quality of life, and medical history are given. The study doctor then determines if the participant continues to qualify for the study. If qualified for the study, patients receive a daily diary to record pain levels and pain medications; this will take about 5 minutes each day. After completion of the diary, patients begin the 8-hour visits. Patients visit the Pain Trials Center three times to receive study medication. After taking the study medication, participants remain in the clinic for 8 hours to complete hourly surveys about pain and pain relief. Subsequent to these visits, patients may enter a 1-month extension where Marinol is taken at home, and pain levels are recorded in a diary. Participants can change the dose of study drug to better control pain and side effects, after speaking with study staff. The study then concludes with a final 30-minute visit to summarize the participant's experience in the clinical trial.
NCT00217971 ↗ Dronabinol Treatment for Marijuana Addiction Completed National Institute on Drug Abuse (NIDA) Phase 2 2005-03-01 The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana addiction and withdrawal.
NCT00217971 ↗ Dronabinol Treatment for Marijuana Addiction Completed New York State Psychiatric Institute Phase 2 2005-03-01 The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana addiction and withdrawal.
NCT00260143 ↗ Testosterone and Physical Function in HIV+ Men Completed Charles Drew University of Medicine and Science Phase 2 2003-05-01 Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though they may try to eat more food to gain weight. The reasons for this weight loss are not clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone that is naturally produced in the bodies of both men and women and has important effects on building muscle and bone mass. The purpose of this study is to find out if providing additional testosterone to HIV infected men who have low testosterone can help them gain weight, increase their muscle mass, and feel better. The study will also help see if testosterone improves the efficiency with which your body produces and uses energy including fat. The dose of testosterone being used in this study will raise testosterone levels in the blood to higher than normal levels (2-3 times normal level).
NCT00260143 ↗ Testosterone and Physical Function in HIV+ Men Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2003-05-01 Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though they may try to eat more food to gain weight. The reasons for this weight loss are not clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone that is naturally produced in the bodies of both men and women and has important effects on building muscle and bone mass. The purpose of this study is to find out if providing additional testosterone to HIV infected men who have low testosterone can help them gain weight, increase their muscle mass, and feel better. The study will also help see if testosterone improves the efficiency with which your body produces and uses energy including fat. The dose of testosterone being used in this study will raise testosterone levels in the blood to higher than normal levels (2-3 times normal level).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Marinol

Condition Name

Condition Name for Marinol
Intervention Trials
Marijuana Dependence 4
Healthy 3
Schizophrenia 3
Marijuana Abuse 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Marinol
Intervention Trials
Marijuana Abuse 19
Disease 6
Stress Disorders, Post-Traumatic 3
Anorexia 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Marinol

Trials by Country

Trials by Country for Marinol
Location Trials
United States 54
Canada 3
Denmark 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Marinol
Location Trials
Maryland 7
New York 7
Illinois 4
Michigan 4
Connecticut 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Marinol

Clinical Trial Phase

Clinical Trial Phase for Marinol
Clinical Trial Phase Trials
Phase 4 8
Phase 3 3
Phase 2/Phase 3 3
[disabled in preview] 38
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Marinol
Clinical Trial Phase Trials
Completed 31
Recruiting 9
Terminated 6
[disabled in preview] 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Marinol

Sponsor Name

Sponsor Name for Marinol
Sponsor Trials
National Institute on Drug Abuse (NIDA) 19
New York State Psychiatric Institute 4
Yale University 4
[disabled in preview] 12
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Marinol
Sponsor Trials
Other 69
NIH 27
Industry 10
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

MARINOL (Dronabinol): Clinical Trials, Market Analysis, and Projections

Introduction to MARINOL (Dronabinol)

MARINOL, known generically as dronabinol, is a synthetic form of tetrahydrocannabinol (THC), the primary psychoactive component of cannabis. It is used primarily for the treatment of nausea and vomiting associated with cancer chemotherapy and for the stimulation of appetite in patients with AIDS-related weight loss.

Clinical Trials Overview

Appetite Stimulation in AIDS Patients

Clinical trials have demonstrated the efficacy of MARINOL in stimulating appetite and improving weight in patients with AIDS-related anorexia. A randomized, double-blind, placebo-controlled study involving 139 patients showed that MARINOL significantly improved appetite as measured by a visual analog scale. Patients were initially treated with 5 mg/day, administered in doses of 2.5 mg one hour before lunch and one hour before supper. The study found sustained improvements in appetite over a six-week period, with trends toward improved body weight and mood, and decreases in nausea[1][4].

Antiemetic Effects in Cancer Patients

MARINOL has also been evaluated for its antiemetic efficacy in patients undergoing cancer chemotherapy. In studies involving 454 patients, MARINOL was found to be particularly effective in patients receiving cytotoxic therapy for Hodgkin’s and non-Hodgkin’s lymphomas. Dosages ranged from 2.5 mg/day to 40 mg/day, administered in equally divided doses every four to six hours. The antiemetic effects of MARINOL were significant, especially in patients undergoing chemotherapy[1].

Pharmacokinetics and Pharmacodynamics

Absorption and Distribution

MARINOL is almost completely absorbed after oral administration, with 90 to 95% absorption rates. However, due to first-pass hepatic metabolism and high lipid solubility, only 10 to 20% of the administered dose reaches the systemic circulation. Dronabinol has a large apparent volume of distribution, approximately 10 L/kg, due to its lipid solubility[1].

Steady-State Levels

Studies have shown that steady-state cannabinoid levels are reached within the first two weeks of treatment, as indicated by the urinary cannabinoid/creatinine ratio. This is consistent with the observed terminal half-life of dronabinol[1].

Adverse Effects

Common Adverse Reactions

The most frequently reported adverse experiences in patients with AIDS involved the central nervous system (CNS), with 33% of patients reporting CNS-related side effects such as feeling high, dizziness, confusion, and somnolence. About 25% of patients reported a CNS adverse reaction during the first two weeks, with a decrease to about 4% per week thereafter[1][4].

Other Side Effects

Other common side effects include body as a whole (asthenia), cardiovascular (palpitations, tachycardia, vasodilation/facial flush), and digestive (abdominal pain, nausea, vomiting) issues[1].

Market Analysis

Current Market Size and Growth

The global dronabinol market was valued at US$ 240.9 million in 2023 and is expected to reach US$ 373.8 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.4% during the forecast period 2024-2030[2].

Market Segmentation

The dronabinol market can be segmented into oral liquid, capsules, and other forms. The oral liquid segment held the largest market share in 2021, driven by the FDA approval for treating nausea associated with cancer chemotherapy and anorexia in AIDS patients. The capsule segment is expected to grow with the fastest CAGR of 7.3% during the forecast period due to its ease of administration and effectiveness in treating disturbed stomach and nausea[3].

Regional Analysis

The market is analyzed across six major regions: North America, Latin America, Europe, Asia Pacific, the Middle East, and Africa. The increasing prevalence of AIDS and the rising need for effective treatments for nausea and vomiting associated with chemotherapy are driving the growth in these regions[5].

Market Drivers

Increasing Applications of Dronabinol

The growing use of dronabinol for treating chronic pain, post-traumatic stress disorder (PTSD), and other conditions is expected to drive market growth. The drug's potential benefits for acute AIDS patients with hunger loss and weight loss are particularly significant[3].

Prevalence of AIDS

According to the World Health Organization (WHO), the prevalence of AIDS remains a significant global health issue, with 650,000 deaths from HIV-related causes and 1.5 million new HIV infections in 2021. This ongoing need for effective treatments for AIDS-related anorexia and weight loss is a key driver for the dronabinol market[3].

Market Projections

Future Growth

The dronabinol market is projected to continue growing, driven by increasing applications and the ongoing need for effective treatments for nausea, vomiting, and appetite loss. The market is expected to reach $351.3 million by 2027, growing at a CAGR of 6.7% during the forecast period 2022-2027[3].

Competitive Landscape

The top five players in the dronabinol market occupy about 44% of the market share. The competitive landscape is expected to evolve with new product launches, technological advancements, and strategic initiatives by key players[2].

Key Takeaways

  • Clinical Efficacy: MARINOL has been shown to be effective in stimulating appetite in AIDS patients and in reducing nausea and vomiting associated with cancer chemotherapy.
  • Pharmacokinetics: The drug is well-absorbed but undergoes significant first-pass metabolism, with steady-state levels reached within two weeks.
  • Adverse Effects: Common side effects include CNS-related symptoms, body as a whole, cardiovascular, and digestive issues.
  • Market Growth: The global dronabinol market is expected to grow at a CAGR of 6.4% from 2024 to 2030, driven by increasing applications and the prevalence of AIDS.
  • Market Segmentation: The oral liquid segment dominates the market, with the capsule segment expected to grow rapidly.

FAQs

What is MARINOL used for?

MARINOL (dronabinol) is used for the treatment of nausea and vomiting associated with cancer chemotherapy and for the stimulation of appetite in patients with AIDS-related weight loss[1][3].

What are the common side effects of MARINOL?

Common side effects include CNS-related symptoms such as feeling high, dizziness, confusion, and somnolence, as well as body as a whole, cardiovascular, and digestive issues[1][4].

How does MARINOL work?

MARINOL works by mimicking the effects of THC, the primary psychoactive component of cannabis, to stimulate appetite and reduce nausea and vomiting[1].

What is the projected growth rate of the dronabinol market?

The global dronabinol market is expected to grow at a CAGR of 6.4% from 2024 to 2030[2].

Which segment dominates the dronabinol market?

The oral liquid segment currently dominates the dronabinol market, driven by its FDA approval and ease of administration[3].

Sources

  1. MARINOL® - accessdata.fda.gov

    • FDA label for MARINOL Capsules[1].
  2. Global Dronabinol Market Research Report 2024

    • Market size and growth projections for the dronabinol market[2].
  3. Dronabinol Market Report, 2022-2027 - IndustryARC

    • Detailed market analysis and segmentation of the dronabinol market[3].
  4. Marinol (Dronabinol Capsules): Side Effects, Uses, Dosage - RxList

    • Clinical trial data and side effects of MARINOL[4].
  5. Dronabinol Market Statistical Forecast and Trade Analysis (2024-2031)

    • Market analysis and trade insights for the dronabinol market[5].

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.