CLINICAL TRIALS PROFILE FOR MARINOL

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).

Clinical Trial Conditions for MARINOL

Condition Name

Condition Name for MARINOL
Intervention	Trials
Marijuana Dependence	4
Marijuana Abuse	3
Cannabis	3
Pain	3

Condition MeSH

Condition MeSH for MARINOL
Intervention	Trials
Marijuana Abuse	19
Disease	6
Anorexia	3
Osteoarthritis, Knee	3

Clinical Trial Locations for MARINOL

Trials by Country

Trials by Country for MARINOL
Location	Trials
United States	56
Canada	3
Denmark	1

Trials by US State

Trials by US State for MARINOL
Location	Trials
Maryland	7
New York	7
Texas	5
California	4
Illinois	4

Clinical Trial Progress for MARINOL

Clinical Trial Phase

Clinical Trial Phase for MARINOL
Clinical Trial Phase	Trials
PHASE2	2
Phase 4	8
Phase 3	3

Clinical Trial Status

Clinical Trial Status for MARINOL
Clinical Trial Phase	Trials
Completed	31
Recruiting	10
Terminated	6

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

Sponsor Type

Sponsor Type for MARINOL
Sponsor	Trials
Other	71
NIH	27
Industry	10

Clinical Trials Update, Market Analysis, and Projection for Marinol (Dronabinol)

Last updated: October 30, 2025

Introduction

Marinol (dronabinol) is a synthetic form of delta-9-tetrahydrocannabinol (THC), approved by the U.S. Food and Drug Administration (FDA) in 1985 for the treatment of chemotherapy-induced nausea and vomiting and AIDS-related anorexia. Over the past decade, the landscape surrounding Marinol has evolved, with increasing interest in botanical cannabis-based therapies, shifts in regulatory frameworks, and expanding indications. This report provides an up-to-date overview of clinical trials involving Marinol, analyzes its current market dynamics, and projects future opportunities.

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Clinical Trials Update

Current Clinical Research Landscape

Despite being approved over three decades ago, Marinol remains an active subject in clinical research, primarily focusing on expanding its therapeutic indications, assessing safety profiles, and comparing efficacy with emerging cannabinoid therapies. A review of recent clinical trials (as registered on ClinicalTrials.gov) indicates ongoing interest:

• New Indications: Recent trials explore Marinol's utility beyond its original indications, including conditions such as multiple sclerosis (MS) spasticity, neuropathic pain, and post-traumatic stress disorder (PTSD).

• Comparative Efficacy: Multiple studies compare Marinol with natural cannabis, other synthetic cannabinoids, and non-cannabinoid agents to evaluate relative safety and efficacy, especially concerning side effect profiles.

• Pharmacokinetics and Safety: Trials investigating optimal dosing, pharmacokinetics, and long-term safety continue to validate Marinol’s clinical utility, especially in vulnerable populations such as pediatric and elderly patients.

Notable Clinical Trials (2021–2023)

1. Dronabinol for MS Spasticity: A Phase II randomized trial published in Neurology (2022) assessed Marinol’s efficacy in reducing spasticity, showing modest benefit but highlighting side effect management challenges.

2. Comparative Study on Pain Management: A trial in Pain Medicine (2023) evaluated Marinol against cannabidiol (CBD) in neuropathic pain, reporting similar efficacy but with different adverse event profiles.

3. Long-term Safety Evaluation: The Journal of Psychopharmacology (2022) published a longitudinal study indicating sustained safety over chronic use, emphasizing liver enzyme stability and cognitive effects.

Regulatory and Market-Driven Impact

Recent regulatory shifts, particularly in jurisdictions like Canada and parts of Europe, have facilitated broader access to cannabis-derived products. Nevertheless, Marinol’s synthetic consistency remains a advantage in clinical settings requiring standardized dosing, supporting its ongoing trial activity.

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Market Analysis

Historical and Current Market Landscape

Marinol's market penetration has historically been limited compared to plant-derived cannabinoid products, largely due to the emergence of diversified cannabis-based therapies. Nevertheless, Marinol maintains a niche role.

• Market Size (Pre-2020): Estimated at USD 50 million worldwide, primarily driven by the U.S. market, with annual growth margins of approximately 3–5%, reflecting slow but steady demand.

• Key Market Segments:

  • Oncology: Utilization for chemotherapy-induced nausea remains the primary market driver.
  • HIV/AIDS Care: Small but consistent demand.
  • Off-label Uses: Emerging off-label prescriptions for conditions such as chronic pain.

• Distribution Channels: Primarily through specialty pharmacies and hospital formularies, with limited over-the-counter (OTC) availability owing to regulatory constraints.

Market Challenges

• Competition: Natural cannabis products, cannabis extracts, and newer synthetic cannabinoids (e.g., nabilone, nabilone derivatives) offer alternative treatment options. The variability in natural products and regulatory hurdles favor Marinol’s standardized formulation for certain clinicians.

• Regulatory Barriers: Despite grandfathering in many markets, ongoing restrictions on synthetic cannabinoids hinder widespread adoption. The reclassification of cannabis medicines influences Marinol’s clinical positioning.

• Pricing and Reimbursement: High costs and inconsistent reimbursement policies in various markets limit accessibility, especially outside the U.S.

Emerging Trends (2022–2023)

• Market Expansion in Europe: Countries such as Germany and the UK are increasingly integrating synthetic cannabinoids into treatment protocols, potentially expanding Marinol’s footprint.

• Cannabis Legalization: Concomitant legalization of recreational cannabis in jurisdictions like Canada influences the competitive landscape, nudging Marinol toward more niche, indication-specific roles.

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Market Projection and Future Outlook

Projections (2023–2030)

1. Growth Rate: The global marinol market is expected to CAGR of approximately 4% through 2030, reaching USD 70–80 million, driven by increased clinical acceptance and expanding indications.

2. Key Opportunities:

   • New Therapeutic Indications: As trials validate Marinol's efficacy in pain, neurodegenerative disorders, and psychiatric conditions, its application scope broadens.
   • Reimbursement Policies: Shifts towards subsidizing cannabinoid therapies in more regions will promote growth.
   • Pharmaceutical Partnerships: Collaborations between biotech firms and established pharma companies could facilitate reformulation, dosage optimization, and broader distribution.

3. Threats:

   • Product Substitution: Growing preference for plant-based cannabis pharmaceuticals and CBD products.
   • Regulatory Uncertainty: Potential reclassification or restrictions may limit market expansion.
   • Emerging Patent Challenges: Competition from patent-expired or generically produced synthetic cannabinoids.

Strategic Considerations

Pharmaceutical companies should consider leveraging Marinol’s established safety profile, especially in patient populations requiring predictable pharmacokinetics. Investing in comparative efficacy studies and expanding indications can underpin future growth. Additionally, engaging with regulators to facilitate easier access procedures could pay dividends.

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Key Takeaways

• Clinical research on Marinol continues, emphasizing expanded therapeutic uses, safety evaluation, and comparative effectiveness, ensuring its relevance in modern cannabinoid medicine.

• Market dynamics are evolving, with moderate growth driven by increased clinical acceptance, regulatory shifts, and expanded indications, especially in Europe and other global markets.

• Market challenges include competition from plant-based cannabis products, regulatory uncertainties, reimbursement issues, and pricing constraints.

• Future projections suggest steady growth, reaching USD 70–80 million worldwide by 2030, with opportunities stemming from new clinical evidence, expanded access, and strategic collaborations.

• Strategic focus areas for stakeholders include investment in clinical validation for broader indications, advocacy for clearer regulatory pathways, and development of formulations optimized for emerging markets.

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FAQs

1. What are the current approved uses for Marinol?
Marinol is approved for nausea and vomiting caused by chemotherapy and for anorexia associated with weight loss in AIDS patients.

2. How does Marinol compare to natural cannabis?
Marinol offers a standardized, pharmaceutical-grade formulation with consistent dosing, whereas natural cannabis varies in potency and composition, which can impact efficacy and safety.

3. Are there ongoing clinical trials investigating new indications for Marinol?
Yes, recent studies assess Marinol’s potential in treating MS spasticity, neuropathic pain, and psychiatric conditions like PTSD.

4. What are the main challenges facing Marinol in the current market?
Key challenges include competition from botanical cannabis products, regulatory restrictions, cost and reimbursement hurdles, and market preference for natural therapies.

5. What strategies might enhance Marinol’s market growth?
Focusing on expanding indication labels through robust clinical evidence, advocating for clearer regulatory pathways, and forming strategic collaborations can facilitate growth.

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References

[1] ClinicalTrials.gov. "Search results for Marinol (dronabinol)." 2023.
[2] FDA. "FDA Approves Marinol for Chemotherapy-Induced Nausea." 1985.
[3] Statista. "Global cannabinoid pharmaceuticals market size and forecasts." 2022.
[4] European Medicines Agency. "Guidance on cannabinoid-based medicinal products." 2021.
[5] Journal of Psychopharmacology. “Long-term safety of dronabinol,” 2022.