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Last Updated: April 28, 2025

CLINICAL TRIALS PROFILE FOR NICOTROL


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All Clinical Trials for NICOTROL

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00000437 ↗ Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone) Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 4 1997-09-26 The purpose of this study is to determine the effectiveness of naltrexone (Revia) or matched placebo combined with nicotine patch (Nicotrol) or placebo patch using a 2x2 design in reducing drinking and smoking in patients with both nicotine and alcohol dependence.
NCT00000437 ↗ Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone) Completed The Scripps Research Institute Phase 4 1997-09-26 The purpose of this study is to determine the effectiveness of naltrexone (Revia) or matched placebo combined with nicotine patch (Nicotrol) or placebo patch using a 2x2 design in reducing drinking and smoking in patients with both nicotine and alcohol dependence.
NCT00061074 ↗ Tobacco Cessation in Postmenopausal Women (Part II) - 2 Completed National Institute on Drug Abuse (NIDA) Phase 1 1993-03-01 The purpose of this study is to evaluate the effects of ERT on appetitive behavior and withdrawal in short-term smoking cessation in postmenopausal females on transdermal nicotine replacement
NCT00061074 ↗ Tobacco Cessation in Postmenopausal Women (Part II) - 2 Completed University of Minnesota Phase 1 1993-03-01 The purpose of this study is to evaluate the effects of ERT on appetitive behavior and withdrawal in short-term smoking cessation in postmenopausal females on transdermal nicotine replacement
NCT00061074 ↗ Tobacco Cessation in Postmenopausal Women (Part II) - 2 Completed University of Minnesota - Clinical and Translational Science Institute Phase 1 1993-03-01 The purpose of this study is to evaluate the effects of ERT on appetitive behavior and withdrawal in short-term smoking cessation in postmenopausal females on transdermal nicotine replacement
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for NICOTROL

Condition Name

3321000.511.522.53Depressive DisorderSmokingSmoking CessationTobacco Use Disorder[disabled in preview]
Condition Name for NICOTROL
Intervention Trials
Depressive Disorder 3
Smoking 3
Smoking Cessation 2
Tobacco Use Disorder 1
[disabled in preview] 0
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Condition MeSH

4321000.511.522.533.54Depressive DisorderTobacco Use DisorderDepressionSubstance-Related Disorders[disabled in preview]
Condition MeSH for NICOTROL
Intervention Trials
Depressive Disorder 4
Tobacco Use Disorder 3
Depression 2
Substance-Related Disorders 1
[disabled in preview] 0
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Clinical Trial Locations for NICOTROL

Trials by Country

+
Trials by Country for NICOTROL
Location Trials
United States 16
Mexico 1
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Trials by US State

+
Trials by US State for NICOTROL
Location Trials
Tennessee 4
Pennsylvania 2
North Carolina 1
District of Columbia 1
Minnesota 1
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Clinical Trial Progress for NICOTROL

Clinical Trial Phase

31.3%25.0%18.7%25.0%02.80000000000000033.00000000000000043.23.43.63.844.24.44.64.855.2Phase 4Phase 2Phase 1[disabled in preview]
Clinical Trial Phase for NICOTROL
Clinical Trial Phase Trials
Phase 4 5
Phase 2 4
Phase 1 3
[disabled in preview] 4
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Clinical Trial Status

62.5%18.8%6.2%12.5%012345678910CompletedNot yet recruitingRecruiting[disabled in preview]
Clinical Trial Status for NICOTROL
Clinical Trial Phase Trials
Completed 10
Not yet recruiting 3
Recruiting 1
[disabled in preview] 2
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Clinical Trial Sponsors for NICOTROL

Sponsor Name

trials011223344National Institute on Drug Abuse (NIDA)Vanderbilt University Medical CenterNational Institute of Mental Health (NIMH)[disabled in preview]
Sponsor Name for NICOTROL
Sponsor Trials
National Institute on Drug Abuse (NIDA) 4
Vanderbilt University Medical Center 4
National Institute of Mental Health (NIMH) 2
[disabled in preview] 3
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Sponsor Type

57.1%35.7%7.1%00246810121416OtherNIHU.S. Fed[disabled in preview]
Sponsor Type for NICOTROL
Sponsor Trials
Other 16
NIH 10
U.S. Fed 2
[disabled in preview] 0
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Transforming Smoking Cessation: Updates on Nicotrol and the Nicotine Replacement Therapy Market

Introduction to Nicotrol and Nicotine Replacement Therapy

Nicotrol, a well-known brand in the nicotine replacement therapy (NRT) market, is part of a broader landscape of treatments aimed at helping individuals quit smoking. With the emergence of new technologies and products, the NRT market is undergoing significant changes.

Clinical Trials Update: RespiRx™ Nicotine Inhaler

A recent development in the NRT sector is the RespiRx™ Nicotine Inhaler, developed by Qnovia, Inc. This product marks a significant advancement as it is the world’s first truly inhalable nicotine replacement therapy.

  • Phase 1 Study: Qnovia, Inc. has announced the first patient dosed in its Phase 1 clinical trial in the U.S. for the RespiRx™ Nicotine Inhaler. This study aims to assess the pharmacokinetics, safety, and tolerability of the inhaler in healthy adult smokers. The trial is a randomized, crossover, open-label study comparing the self-administration of RespiRx™ Nicotine Inhaler, Nicotrol® Inhaler, or combustible cigarettes in up to 24 participants[1].

  • Expected Outcomes: Clinical data from this Phase 1 study is anticipated in Q2 2025. This data will be crucial in determining the efficacy and safety of the RespiRx™ Nicotine Inhaler as a smoking cessation therapy.

Market Analysis of Nicotine Replacement Therapies

The market for nicotine replacement therapies, including products like Nicotrol, is growing due to several factors.

Global Nicotine Addiction Treatment Market

  • The global nicotine addiction treatment market is projected to exhibit a CAGR of around 6.50% from 2021 to 2028. This growth is driven by rising government policies, increasing awareness about the harmful effects of nicotine, and higher personal disposable income[3].

Nicotine Pouches Market

  • The global nicotine pouches market, which is part of the broader NRT market, was estimated at USD 3.95 billion in 2024 and is expected to grow at a CAGR of 34.4% from 2025 to 2030. This growth is fueled by the increasing interest in alternative products that do not involve lung exposure, particularly among younger consumers[5].

U.S. Nicotine Pouches Market

  • In the U.S., the nicotine pouches market is expected to grow at a CAGR of 33.7% from 2025 to 2030. Large-scale companies such as Altria Group, Inc., Reynolds American Inc., and Imperial Brands Plc are driving this growth through extensive strategic initiatives like product launches and innovations[5].

Market Projections and Trends

Growing Demand for Alternative Products

  • The rising demand for cigarette smoking alternatives is a key driver of the NRT market. Consumers are increasingly looking for products that are safer and do not involve the negative effects of smoke or inhalation. For instance, the demand for synthetic nicotine pouches is expected to grow at a CAGR of 46.5% from 2025 to 2030 in the U.S.[2].

Regional Growth

  • In regions like Asia Pacific, particularly in China and India, the nicotine pouches market is expected to grow significantly. China’s market is projected to grow at a CAGR of 48.1%, while India’s market is expected to grow at a CAGR of 47.1% from 2025 to 2030. These growth rates are driven by regulatory measures, health concerns, and increasing consumer awareness[5].

Competitive Landscape

  • The NRT market is highly competitive, with several key players introducing new products to meet the growing demand. For example, British American Tobacco (BAT) announced the launch of synthetic nicotine pouches under its Velo Plus product line in the U.S., scheduled for 2025[2].

Consumer Awareness and Interest

  • Consumer awareness and interest in nicotine pouches and other NRT products are on the rise. A study by Rutgers University found that approximately 29% of U.S. smokers were aware of nicotine pouches, 6% had tried them, and 17% were interested in trying them[5].

Regulatory Environment

  • Regulatory measures play a crucial role in shaping the NRT market. For instance, the Chinese government's tightening regulations on traditional tobacco products have led to an increase in the sales volume of alternative tobacco products, including nicotine pouches[5].

Innovations in Drug Delivery Systems

  • Innovations in drug delivery systems are transforming the NRT market. Qnovia’s RespiRx™ platform, for example, is an orientation-agnostic, portable vibrating mesh nebulizer that effectively operates in any position held by the patient. This technology has the potential to improve patient outcomes across various indications, including smoking cessation[1].

Key Takeaways

  • The NRT market, including products like Nicotrol, is experiencing significant growth driven by consumer demand for safer alternatives to smoking.
  • New technologies, such as the RespiRx™ Nicotine Inhaler, are being developed to enhance the efficacy and safety of NRTs.
  • Regulatory measures and increasing consumer awareness are key factors driving the growth of the NRT market.
  • Regional markets, particularly in Asia Pacific, are expected to see substantial growth in the coming years.

FAQs

What is the RespiRx™ Nicotine Inhaler?

The RespiRx™ Nicotine Inhaler is a new nicotine replacement therapy developed by Qnovia, Inc., designed to be the world’s first truly inhalable nicotine replacement therapy.

What is the current status of the Phase 1 study for RespiRx™ Nicotine Inhaler?

The first patient has been dosed in the Phase 1 clinical trial in the U.S., and clinical data is expected in Q2 2025.

How is the global nicotine addiction treatment market projected to grow?

The global nicotine addiction treatment market is expected to exhibit a CAGR of around 6.50% from 2021 to 2028.

What drives the growth of the nicotine pouches market?

The growth of the nicotine pouches market is driven by increasing consumer awareness, rising demand for cigarette smoking alternatives, and diverse product offerings.

Which regions are expected to see significant growth in the nicotine pouches market?

Asia Pacific, particularly China and India, are expected to see significant growth in the nicotine pouches market from 2025 to 2030.

Sources

  1. Qnovia, Inc. Announces First Patient Dosed in U.S. in Phase 1 study for RespiRx™ Nicotine Inhaler as a prescription smoking cessation therapy. PR Newswire, January 7, 2025.
  2. U.S. Nicotine Pouches Market Size | Industry Report, 2030. Grand View Research.
  3. Nicotine Addiction Treatment Market – Global Industry Trends and Forecast to 2028. Data Bridge Market Research.
  4. Cytisinicline for Vaping Cessation in Adults Using Nicotine E-Cigarettes: A Randomized Clinical Trial. JAMA Internal Medicine, May 6, 2024.
  5. Nicotine Pouches Market Size & Share | Industry Report 2030. Grand View Research.

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