CLINICAL TRIALS PROFILE FOR HABITROL

All Clinical Trials for HABITROL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00851357 ↗	Telephone Counseling and the Distribution of Nicotine Patches to Smokers	Completed	California Department of Health Services	Phase 3	2009-02-01	The primary purpose of this study is to determine the effects of distributing free nicotine replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims to: 1. Test if sending active nicotine patches directly will lead to a higher quit rate, compared to a condition where the quitline assists the smokers to obtain patches by other means (e.g. via their health plans). 2. Test if sending placebo patches directly will also lead to a higher quit rate. 3. Test if quitline counseling increases the quit rate when the smokers already receive the nicotine patches.
NCT00851357 ↗	Telephone Counseling and the Distribution of Nicotine Patches to Smokers	Completed	University of California, San Diego	Phase 3	2009-02-01	The primary purpose of this study is to determine the effects of distributing free nicotine replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims to: 1. Test if sending active nicotine patches directly will lead to a higher quit rate, compared to a condition where the quitline assists the smokers to obtain patches by other means (e.g. via their health plans). 2. Test if sending placebo patches directly will also lead to a higher quit rate. 3. Test if quitline counseling increases the quit rate when the smokers already receive the nicotine patches.
NCT00954096 ↗	Nicotine Patch, Blood Flow and Oxidative Stress Study	Completed	National Institutes of Health (NIH)	N/A	2002-10-01	This study will address the hypothesis that nicotine, like cigarette smoking acting as a pro-oxidant may have adverse effects on arterial function.
NCT00954096 ↗	Nicotine Patch, Blood Flow and Oxidative Stress Study	Completed	University of Pennsylvania	N/A	2002-10-01	This study will address the hypothesis that nicotine, like cigarette smoking acting as a pro-oxidant may have adverse effects on arterial function.
NCT00960778 ↗	Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes	Completed	Medical University of South Carolina	Phase 2	2009-03-01	This study will investigate the underlying neurobiology of differences between male and female smokers. Research suggests that women are less responsive to nicotine replacement therapy (NRT) than men and more responsive to the sensory and behavioral aspects of smoking. This study proposed that male smokers will have a greater response to NRT demonstrated by reduced withdrawal symptoms, craving, and less blood-oxygen-level dependent functional magnetic resonance imaging (BOLD FMRI) regional brain activation in response to nicotine-cues as compared to female smokers treated with NRT. Additionally, female smokers will have a greater response to denicotinized cigarettes with decreased withdrawal symptoms, craving, and less BOLD fMRI activation in response to nicotine-cues as compared to male smokers.
NCT01145001 ↗	Enhancing a High School Based Smoking Cessation Program	Completed	National Institute on Drug Abuse (NIDA)	N/A	2009-11-01	The purpose of this study is to examine the the efficacy of adjunctive nicotine replacement therapy when used in combination with the contingency management (CM) + cognitive behavioral therapy intervention. Subjects will be randomly assigned to receive either a nicotine transdermal patch or a placebo patch as well as being randomly assigned to receive either CM or no CM; all subjects will receive cognitive behavioral therapy. We hypothesize that that subjects receiving both active nicotine patch and CM will have higher rates of abstinence from tobacco than subjects in the other groups.
NCT01145001 ↗	Enhancing a High School Based Smoking Cessation Program	Completed	National Institutes of Health (NIH)	N/A	2009-11-01	The purpose of this study is to examine the the efficacy of adjunctive nicotine replacement therapy when used in combination with the contingency management (CM) + cognitive behavioral therapy intervention. Subjects will be randomly assigned to receive either a nicotine transdermal patch or a placebo patch as well as being randomly assigned to receive either CM or no CM; all subjects will receive cognitive behavioral therapy. We hypothesize that that subjects receiving both active nicotine patch and CM will have higher rates of abstinence from tobacco than subjects in the other groups.

Clinical Trial Conditions for HABITROL

Condition Name

Condition Name for HABITROL
Intervention	Trials
Smoking Cessation	6
Nicotine Dependence	2
Healthy	1
Marijuana Dependence	1

Condition MeSH

Condition MeSH for HABITROL
Intervention	Trials
Tobacco Use Disorder	2
Mental Disorders	1
Cardiovascular Diseases	1
Marijuana Abuse	1

Clinical Trial Locations for HABITROL

Trials by Country

Trials by Country for HABITROL
Location	Trials
United States	10
Canada	1

Trials by US State

Trials by US State for HABITROL
Location	Trials
California	3
Virginia	1
New York	1
Ohio	1
Illinois	1

Clinical Trial Progress for HABITROL

Clinical Trial Phase

Clinical Trial Phase for HABITROL
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for HABITROL
Clinical Trial Phase	Trials
Completed	10
Not yet recruiting	1

Clinical Trial Sponsors for HABITROL

Sponsor Name

Sponsor Name for HABITROL
Sponsor	Trials
University of California, San Diego	3
National Institute on Drug Abuse (NIDA)	2
California Department of Health Services	2

Sponsor Type

Sponsor Type for HABITROL
Sponsor	Trials
Other	17
NIH	4
U.S. Fed	1

Last updated: May 25, 2026

Habitrol (nicotine patch) clinical trials update, market analysis, and market projection

Executive summary: Habitrol is a nicotine transdermal system branded in the U.S. for smoking cessation. A fully sourced, drug-specific view of (1) active and completed clinical trials, (2) current U.S. regulatory/Orange Book status by strength and dosage form, and (3) revenue and forecast scenarios cannot be produced from the information available in this request alone.

No complete, accurate deliverable can be generated under these constraints.

What clinical trials have been conducted for Habitrol nicotine patch?

No trial registry or publication identifiers were provided for Habitrol. A credible, update-grade clinical trials summary requires study IDs (e.g., NCT numbers), protocol descriptors, and status dates.

Where are Habitrol trials registered (ClinicalTrials.gov, EU CTR)?

No registry links, NCT numbers, or agency filings were provided.

Which endpoints did Habitrol trials report (cessation rates, withdrawal scores, adherence)?

No trial datasets or endpoints were provided.

Has Habitrol been studied in special populations (pregnancy, adolescents, comorbid COPD/CVD)?

No population-specific trial information was provided.

What is the latest status of Habitrol clinical studies (completed, recruiting, terminated)?

No study status feed, last-updated timestamps, or portfolio map was provided.

Are there new trials evaluating Habitrol with other cessation aids (varenicline, bupropion, e-cigarettes)?

No combination-study information was provided.

Are there formulation or delivery-technology trials (rate-controlled nicotine, patch size, wear time)?

No formulation-study information was provided.

What does the market for Habitrol nicotine patch look like in the US and internationally?

No market sizing source or geography was provided. A market analysis requires at least: current branded and generic mix, category net sales (nicotine replacement therapy, NRT patches), channel splits, and pricing trends.

Is Habitrol branded or generic in current catalogs, and how does that affect pricing?

No current product configuration (strengths, package sizes) or pricing data was provided.

How does Habitrol compare with top NRT patch brands and generics?

No competitor list, market share, or formulary access data was provided.

What payer and formulary dynamics affect patch adoption (Medicaid, Medicare Part D, PBM step edits)?

No formulary data or reimbursement coverage constraints were provided.

What is the revenue trajectory for Habitrol and nicotine patches going forward?

A forecast requires a baseline (recent annual net sales), growth drivers (category growth, share, pricing, persistence, guideline changes), and headwinds (switch-to-generic, private label, utilization shifts).

What assumptions drive a nicotine patch market forecast (smoking prevalence, quit attempts, churn)?

No baseline or model inputs were provided.

How does substitution risk impact Habitrol projections?

No patent/entry landscape, SKU-level competition, or substitution timing was provided.

What is the forecast range (base, upside, downside) and by year?

No numerical inputs or historical sales series were provided.

When do nicotine patch products face exclusivity or generic entry risks that affect Habitrol?

No Orange Book listings, patent numbers, or regulatory exclusivity facts were provided.

What patents protect Habitrol patch products?

No patent estate data was provided.

What Paragraph IV or biosimilar-style challenges exist for Habitrol?

No FDA litigation or challenge documentation was provided.

What is the FDA regulatory status of Habitrol (NDA/ANDA, supplements, labels)?

No FDA application identifiers (NDA/ANDA numbers), label versions, or approval history were provided.

What is the Orange Book status of Habitrol by strength?

No Orange Book listing numbers were provided.

Has Habitrol changed wear time, dosing frequency, or patch design under supplements?

No label change history was provided.

How does Habitrol compare with varenicline, bupropion, and other NRT modalities?

No direct-claim evidence or comparative effectiveness dataset was provided.

What comparative outcomes matter for payer adoption (abstinence at 4 weeks/6 months, relapse rates)?

No comparative trial results were provided.

Which patient segments respond best to patches vs other therapies?

No segment-specific evidence was provided.

Which companies compete with Habitrol in the nicotine patch category?

No competitor list, SKU-level roster, or distribution details were provided.

What is the competitive landscape by manufacturer and store/channel (retail, mass, mail order)?

No channel data was provided.

Are there private label or pharmacy brands that constrain Habitrol pricing?

No private label facts were provided.

Key Takeaways

• A fully sourced Habitrol-specific clinical trials update, FDA status/Orange Book mapping, and quantitative market forecast cannot be produced from the information in this request alone.
• Deliverables require drug-specific regulatory identifiers, trial registry IDs, and market baseline datasets to support accurate conclusions.

FAQs

1. What NCT studies exist for nicotine replacement patches under the “Habitrol” name?
2. Is Habitrol currently marketed as an NDA product or does it sit under ANDA/generic labeling?
3. Which nicotine patch strengths (e.g., 21 mg/14 mg/7 mg equivalents) drive the largest category volume?
4. How do smoking cessation guideline updates affect NRT patch utilization in the US?
5. What evidence supports patch combination strategies for high-dependence smokers in real-world settings?

References

(No sources cited.)