Clinical trials: Nicotine Replacement Therapy
Smoking Cessation, Harm Reduction
Evaluate Harm Reduction Products as a Second Line Intervention for Adult Smokers Who Do Not Quit With NRT
This study will determine whether a range of products along the reduced-risk continuum can reduce smoke exposure for individuals who fail to quit smoking using current medically approved nicotine replacement therapy (NRT)…
- Trial name
- NCT06088862
- Testing
- Nicoderm, Nicorette 4Mg Chewing Gum, Nicorette Lozenge Product
- Where
- 2 sites in United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Rose Research Center, LLC
Tobacco Dependence
Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum
This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum.
- Trial name
- NCT01152749
- Testing
- Nicotine, Nicotine Gum
- Where
- Sweden
- Volunteers
- 76 people
- Sponsor
- McNeil AB
Tobacco Dependence
Study to Determine if a New Nicotine Replacement Therapy Can Safely Help Smokers to Quit Smoking
This study is to see if a new nicotine replacement therapy safely helps people to quit smoking if it is used the way it would be if it were sold at the pharmacy and used at home.
- Trial name
- NCT01296698
- Testing
- Nicotine
- Where
- 19 sites in United States
- Volunteers
- 257 people
- Sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Healthy Highly Dependant Smokers
Assessment of V0018 2.5 mg Effect on Craving
The purpose of this study is to evaluate the reduction of craving and its time course after administration of V0018 2.5 mg compared to placebo in healthy highly dependant smokers.
- Trial name
- NCT02357888
- Testing
- V0018
- Where
- France
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Pierre Fabre Medicament
Growth Hormone Deficiency
A Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin
The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.
- Trial name
- SkyPASS (NCT05775523)
- Testing
- No intervention
- Where
- 27 sites in United States
- Volunteers
- 500 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Tobacco Dependence
Clinical Study to Assess Bioequivalence Between Nicorette Extra Mint Gum and Nicorette® Mint Gum in Healthy Smokers
This is a research study to verify the same effectiveness and safety profile for the test products, nicotine 2 mg gum and nicotine 4 mg gum, as for the already approved products, Nicorette Mint 2 mg gum and Nicorette Mint 4 mg…
- Trial name
- NCT03259607
- Testing
- Nicorette Extra Mint 2 mg Gum, Nicorette Mint 2 mg Gum, Nicorette Extra Mint 4mg Gum
- Where
- China
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- McNeil AB
Smoking Cessation
Provoked Craving Relief Study by NRT
This study is designed to assess the ability of the mint nicotine mouth strip to relieve provoked cigarette craving in light smokers compared to nicotine lozenge and nicotine gum.
- Trial name
- NRT (NCT01476202)
- Testing
- nicotine
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tobacco Dependence
Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.
- Trial name
- NCT01084707
- Testing
- Oral Nicotine, Nicotine Lozenge, Nicotine gum
- Where
- Sweden
- Volunteers
- 40 people
- Sponsor
- McNeil AB
Smoking
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol).
The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile (rate and amount of nicotine absorbed) following a single use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product…
- Trial name
- NCT01967706
- Testing
- mTHS, mCC, NRT
- Where
- Japan
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Tobacco Dependence
Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products
Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study in healthy smokers.
- Trial name
- NCT01234896
- Testing
- Nicotine Medicated Gum, 4 mg Nicotine Gum, 2 mg Nicotine Gum
- Where
- Sweden
- Volunteers
- 44 people
- Sponsor
- McNeil AB
Smoking
Clinical Study of Smoke-Break Liquid Cigarettes
The purpose of this study is to determine whether the Smoke-Break nicotine delivery device can help smokers quit smoking, while avoiding many of the side effects associated with other smoking cessation products.
- Trial name
- NCT00715871
- Testing
- Nicotine, Smoke-Break nicotine delivery device
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Smoke-Break, Inc.
Tobacco Dependence
Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum
A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.
- Trial name
- NCT01368016
- Testing
- Nicotine
- Where
- 2 sites in Sweden
- Volunteers
- 346 people
- Sponsor
- McNeil AB
Smoking Cessation
Safety and Efficacy Study of the NRT CQSS2 System for Smoking Cessation in Treatment-Seeking Subjects
Transdermal nicotine delivery systems are a cigarette smoking cessation aid designed to deliver nicotine into the systemic circulation via the skin.
- Trial name
- NCT03178422
- Testing
- CQSS2, NicoDerm CQ Patch
- Where
- 5 sites in United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Chrono Therapeutics, Inc.
Growth Hormone Deficiency, Endocrine System Diseases
A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency
A 38-week dosing trial of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus placebo-control.
- Conditions
- Growth Hormone Deficiency, Endocrine System Diseases, Hormone Deficiency
- Trial name
- foresiGHt (NCT04615273)
- Testing
- Lonapegsomatropin, Somatropin
- Where
- 113 sites in United States, Armenia and 22 more
- Volunteers
- 264 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Smoking Cessation
Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation.
This study will investigate the efficacy of EVT 302, a potent and selective inhibitor of Monoamine Oxidase - B, in improving quit rates in chronic cigarette smokers who are motivated to quit smoking.
- Trial name
- NCT00738595
- Testing
- EVT 302, EVT 302 plus open label Nicotine replacement
- Where
- 9 sites in Germany
- Volunteers
- 400 people
- Sponsor
- Evotec Neurosciences GmbH
Healthy
A Study to Assess the Nicotine Pharmacokinetics, Tolerability and Safety With a New Oral Nicotine Replacement Product in Healthy Japanese Smokers
In Part 1, the purpose of this study is to elucidate the single-dose pharmacokinetic profiles of 1 spray and 2 consecutive sprays of oromucosal nicotine spray (ONS) in comparison with those of nicotine gum and cigarette smoking…
- Trial name
- NCT03398876
- Testing
- Oromucosal Nicotine Spray (ONS), Nicotine Gum, Cigarette
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
Tobacco Dependence
Pharmacokinetics With Two New Oral Nicotine Replacement Products and Nicorette® Gum
Single-dose pharmacokinetics with two new oral nicotine replacement products and Nicorette® gum.
- Trial name
- NCT01152723
- Testing
- Nicotine
- Where
- Sweden
- Volunteers
- 28 people
- Sponsor
- McNeil AB
Smoking Cessation
Smoking Reduction or Cessation With Nicotine Replacement Therapy
The purpose of this study is to test the success rate of smoking reduction or cessation with different nicotine products.
- Trial name
- NCT00840242
- Testing
- Nicotine gum, Nicotine inhaler
- Where
- 2 sites in Czechia
- Volunteers
- 314 people
- Sponsor
- McNeil AB
Smoking Cessation
Nicotine Lozenge Bioequivalence Study
To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.
- Trial name
- NCT01536704
- Testing
- Nicotine (2 mg), Nicotine (4 mg)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tobacco Dependence
Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.
Comparative pharmacokinetic study of new oral nicotine replacement therapy products.
- Trial name
- NCT01227720
- Testing
- Experimental Nicotine Replacement Therapy (NRT) 2 mg, Experimental Nicotine Replacement Therapy (NRT), Marketed Nicotine Lozenge
- Where
- 2 sites in Sweden
- Volunteers
- 104 people
- Sponsor
- McNeil AB