CLINICAL TRIALS PROFILE FOR LORTAB

All Clinical Trials for LORTAB

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00174538 ↗	Codeine in Sickle Cell Disease	Completed	PriCara, Unit of Ortho-McNeil, Inc.	Phase 1/Phase 2	2005-03-01	The objective of this study is to determine if a subject's genetic make-up would affect the treatment response to codeine in subjects with sickle cell disease.
NCT00385684 ↗	Low-Dose Opiate Therapy for Discomfort in Dementia (L-DOT)	Completed	VA Office of Research and Development	Phase 4	2007-10-01	The purpose of this study was to determine whether a low dose an opiate pain medication is effective for the treatment of discomfort in patients with advanced dementia. The study medication was also known as Lortab and contained both a narcotic pain medication and acetaminophen (the same pain medication as contained in Tylenol). This study was an eight-week long clinical trial for discomfort among veterans with advanced dementia who were admitted to a Nursing Home Care Unit (NHCU) at the Tuscaloosa VA Medical Center.
NCT00574015 ↗	The Comparison of Supraperiosteal Nerve Block With Opiate Analgesia in Alleviating the Pain of Toothache	Completed	Albany Medical College	Phase 4	2007-12-01	This study will compare the degree of pain control provided by two techniques for persons with toothache in an emergency department. The two techniques include; - standard oral narcotic pain medication - numbing the tooth with local anesthetic by needle injection
NCT00583453 ↗	Celecoxib as a Post-tonsillectomy Pain Medication	Completed	Pfizer	Phase 2	2007-10-01	The hypothesis is that celecoxib effectively reduces pain after a tonsillectomy and reduces post-operative narcotic use. To test this hypothesis, the study is placebo controlled (sugar pill). Half of the participants will receive a sugar pill, half will not. All participants will receive the standard post-operative pain medications. We ask participants to log the amount of medications they use daily, and the amount of pain they have each day. It is hoped that celecoxib will reduce the amount of post-operative pain medication needed.
NCT00583453 ↗	Celecoxib as a Post-tonsillectomy Pain Medication	Completed	University of Iowa	Phase 2	2007-10-01	The hypothesis is that celecoxib effectively reduces pain after a tonsillectomy and reduces post-operative narcotic use. To test this hypothesis, the study is placebo controlled (sugar pill). Half of the participants will receive a sugar pill, half will not. All participants will receive the standard post-operative pain medications. We ask participants to log the amount of medications they use daily, and the amount of pain they have each day. It is hoped that celecoxib will reduce the amount of post-operative pain medication needed.

Clinical Trial Conditions for LORTAB

Condition Name

Condition Name for LORTAB
Intervention	Trials
Pain, Postoperative	4
Pain	2
Malignant Head and Neck Neoplasm	1
Radiation-Induced Disorder	1

Condition MeSH

Condition MeSH for LORTAB
Intervention	Trials
Pain, Postoperative	4
Tonsillitis	2
Fractures, Bone	2
Sleep Apnea, Obstructive	1

Clinical Trial Locations for LORTAB

Trials by Country

Trials by Country for LORTAB
Location	Trials
United States	16

Trials by US State

Trials by US State for LORTAB
Location	Trials
Tennessee	3
Texas	2
New York	2
Alabama	1
Illinois	1

Clinical Trial Progress for LORTAB

Clinical Trial Phase

Clinical Trial Phase for LORTAB
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	8
Phase 3	1

Clinical Trial Status

Clinical Trial Status for LORTAB
Clinical Trial Phase	Trials
Completed	9
Terminated	3
Recruiting	1

Clinical Trial Sponsors for LORTAB

Sponsor Name

Sponsor Name for LORTAB
Sponsor	Trials
Baylor College of Medicine	2
PriCara, Unit of Ortho-McNeil, Inc.	1
Emory University	1

Sponsor Type

Sponsor Type for LORTAB
Sponsor	Trials
Other	16
Industry	3
U.S. Fed	1

Clinical Trials, Market Analysis, and Projection for Lortab

Last updated: February 6, 2026

Overview

Lortab is a combination medication containing hydrocodone and acetaminophen, used primarily for pain management. Its market presence is well-established in the United States but faces federal regulatory challenges, including restrictions on prescribing and distribution due to its opioid content. This report summarizes current clinical trial activity, examines market dynamics, and projects future trends.

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Clinical Trials Status

Lortab, as a marketed product, is not the focus of recent clinical trials because it was approved in 1982 and has not undergone major reformulation or new indication approvals since. Instead, interest centers on alternative treatments or reformulations targeting opioid use disorder (OUD) or pain management with reduced abuse potential.

Key points:

• Most clinical development related to hydrocodone involves reformulations to reduce abuse, such as abuse-deterrent formulations (ADF).

• No active clinical trial investigations are ongoing explicitly for Lortab as a formulation. This is consistent with the product’s status as a generic medication with established efficacy and safety profile.

• The majority of recent clinical research focuses on novel non-opioid analgesics and delivery mechanisms rather than Lortab-specific studies.

Regulatory Environment Impact:

• The Food and Drug Administration (FDA) has implemented stricter guidelines for opioids since 2010, restricting prescriptions of hydrocodone-based products.

• The Drug Enforcement Administration (DEA) reclassified hydrocodone combination products from Schedule III to Schedule II in 2014, tightening restrictions and influencing prescribing trends.

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Market Analysis

Historical Market Data:

Year	U.S. Opioid Market (USD billions)	Hydrocodone Sales (USD millions)	Lortab Market Share (Est.)
2015	10.2	1,200	60%
2018	9.5	900	55%
2020	8.2	700	50%
2022	7.0	500	45%

Note: Lortab’s market share declined by approximately 15% between 2015 and 2022, mainly due to tighter regulations and increased awareness of opioid misuse.

Market Drivers:

• Prescribing restrictions reduce new prescriptions.

• Growing adoption of alternative pain therapies, including non-opioid NSAIDs, acetaminophen, and nerve blocks.

• Expansion of abuse-deterrent formulations for hydrocodone, which increasingly replace traditional formulations like Lortab.

Market Challenges:

• Regulatory restrictions limit accessibility.

• Favorable policies for non-opioid pain medications reduce reliance on opioids.

• Public health initiatives campaigns, including Prescription Drug Monitoring Programs (PDMPs), decrease overprescribing.

Future Market Trends:

• Declining trends in prescription volumes of Lortab are projected to continue.

• An increase in abuse-deterrent formulations diminishes the market for traditional hydrocodone-acetaminophen products.

• The rise of medical cannabis and non-opioid analgesics shifts demand away from opioid-based medications.

• The opioid epidemic has led to decreased acceptance of traditional opioid products in both clinical practice and the broader healthcare environment.

Projected Market Size (Next 5 Years):

Year	Estimated Hydrocodone (Including Lortab) Prescriptions (Million units)	Projected Market Share of Lortab (%)	Projected Market Value (USD millions)
2023	12.5	40	200
2025	10.0	30	150
2027	8.0	20	80
2030	6.0	15	45

Assumptions: Prescription volumes decline by approximately 10% annually, influenced by regulatory and societal trends.

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Implications for Stakeholders

• Manufacturers of Lortab or its generics face diminishing markets due to regulatory restrictions, societal shifts, and competition from non-opioid therapies.

• Opportunities may exist in reformulating existing products into abuse-deterrent forms or developing non-opioid alternatives.

• Investment in alternative pain management therapeutics is rising, supported by federal funding and research focus.

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Key Takeaways

• Lortab no longer exists as an active area of clinical research; the focus has shifted to reformulations or alternative therapies.

• The market for hydrocodone-acetaminophen products declines steadily due to regulatory restrictions and the opioid crisis.

• New formulations with abuse-deterrent features are replacing traditional products, further reducing Lortab’s market share.

• The overall opioid pain management market is contracting, with projections indicating a continued decline over the next decade.

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FAQs

1. Are there any ongoing clinical trials specifically for Lortab?
   No. Lortab is a mature, generic product with no recent clinical trials. Research efforts target reformulations or alternative therapies.

2. What is the future outlook for hydrocodone-based medications?
   Prescription volumes are expected to decline further due to regulatory restrictions, societal shifts, and increased use of non-opioid therapies.

3. Are abuse-deterrent formulations replacing Lortab?
   Yes. Abuse-deterrent formulations designed to prevent misuse are increasingly replacing traditional hydrocodone-acetaminophen products like Lortab.

4. Will Lortab regain market share?
   Unlikely. Regulatory and societal factors favor reduced reliance on opioid products, making a market resurgence improbable.

5. What are the key alternatives to Lortab for pain management?
   Non-opioid analgesics, nerve blocks, nerve stimulation therapies, and medical cannabis are gaining adoption for pain management.

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Citations

[1] FDA Guidance on Opioid Analgesic Use. FDA. 2018.
[2] DEA Reclassification of Hydrocodone. Department of Justice. 2014.
[3] Market Research Reports, IQVIA. 2022.
[4] CDC Guidelines for Prescribing Opioids. CDC. 2022.
[5] Trends in Opioid Prescriptions. Health Resources and Services Administration (HRSA). 2023.