Nicotine lozenge for Smoking, Cessation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Moffitt Cancer Center, Tampa, FL
Smoking, Cessation
Nicotine lozenge - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new treatment for smoking cessation is more effective than the standard treatment.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Smoking, Cessation

Study Objectives

This trial is evaluating whether Nicotine lozenge will improve 1 primary outcome and 4 secondary outcomes in patients with Smoking, Cessation. Measurement will happen over the course of 12 Month Follow-Up.

12 Month Follow-Up
30 Day Smoking Abstinence
Continuous Smoking Abstinence
Self Reported 24 Hours Smoking Abstinence
Self Reported 7 Day Abstinence Smoking Status
Smoking Status by Saliva Cotinine Kit

Trial Safety

Safety Progress

1 of 3

Other trials for Smoking, Cessation

Trial Design

2 Treatment Groups

Standard Treatment
1 of 2
Automated Treatment
1 of 2
Active Control
Experimental Treatment

This trial requires 500 total participants across 2 different treatment groups

This trial involves 2 different treatments. Nicotine Lozenge is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Automated TreatmentParticipants randomized to Automated Treatment (AT) will be given a 10-week supply of nicotine patches and lozenges. AT will also comprise of: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and/or negative affect/stress; 2) 26 weeks of on-demand access to treatment content; 3) 26 weeks of text content
Standard TreatmentParticipants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with Florida Quitline services and will complete weekly 4-item smartphone assessments electronically for 26 weeks. The weekly assessments consist of questions on smoking status, motivation, self-efficacy, and perceived stress.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Smartphone-delivered automated treatment
2017
Completed Phase 4
~40
Nicotine
FDA approved
Nicotine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 month follow-up
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 month follow-up for reporting.

Closest Location

Moffitt Cancer Center - Tampa, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You smoke at least 5 cigarettes/day. show original
smoked >/=100 cigarettes in lifetime
English or Spanish speaking
Willing to make a quit attempt within 1 week of enrollment
HIV positive
Process a smartphone compatible with the project app
You have a valid email address. show original

Patient Q&A Section

What are the signs of smoking, cessation?

"Cigarette smoking is linked to a constellation of signs and symptoms which are highly variable and change with smoking history and individual susceptibility. The most effective smoking cessation strategy is a gradual withdrawal procedure which involves stopping all smoking for a period of at least 2 weeks, followed by 4 weeks of reduced smoking." - Anonymous Online Contributor

Unverified Answer

How many people get smoking, cessation a year in the United States?

"Approximately 7.1 million US adults, or 30% of the adult smokers in the US were advised to quit smoking in 2011. In 2010, 21% of adult smokers reported that they had tried to quit smoking but quit without help from a provider, whereas 32% of adult ex-smokers reported that they tried to quit without help from a provider during the preceding 12 years. Among adults who reported attempts to quit, less than one-fourth made arrangements to quit during the previous year." - Anonymous Online Contributor

Unverified Answer

What is smoking, cessation?

"The first tobacco product to be introduced in the European Community (LF) (1964) was a cigarette. In 1964, the first British smokeless tobacco was introduced. The smoking epidemic started in 1964. It is a devastating scourge in the USA, Australia, New Zealand, United Kingdom and Europe. A national ban has a high likelihood of achieving a cessation rate of 70 to 85%. There is no smoking in restaurants, bars, sporting grounds, colleges and medical and dental facilities. This ban will save 30 000 lives annually in the United Kingdom. There is no smoking on ships, planes and ferries. There is a strong ban on the retail display of tobacco products to children. There is also no smoking in railway coaches and in airports." - Anonymous Online Contributor

Unverified Answer

Can smoking, cessation be cured?

"There is an urgent need to investigate whether interventions, which are likely to be well received by patients and practitioners, can encourage smoking cessation and reduce relapse rates among those who quit." - Anonymous Online Contributor

Unverified Answer

What causes smoking, cessation?

"Smoking is the number one cause of lung cancer and lung cancer is one of the leading causes of lung cancer death. It is likely prudent to adopt [smoking cessation](https://www.withpower.com/clinical-trials/smoking-cessation) plans early and comprehensively." - Anonymous Online Contributor

Unverified Answer

What are common treatments for smoking, cessation?

"The use of a multitude of tactics may be needed to decrease tobacco consumption. The most commonly prescribed methods include medication, psychotherapy, and self-help book or device. More research is needed to determine the most effective and safest tactic." - Anonymous Online Contributor

Unverified Answer

What does nicotine lozenge usually treat?

"Most patients find it difficult to quit smoking within a year. Nicotine lozenges can reduce the number of cigarettes smoked, quit smoking faster, and the chances of relapse are much lower. Lozenge users have a 1.9 times greater chance of quitting compared to nicotine patch users." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of nicotine lozenge?

"Nicotine lozenges produce common, moderate-to-severe adverse effects at levels that exceed those associated with inhalation of nicotine. Most of these side effects resolve by a number of weeks post-treatment. Common adverse effects include mild (typically temporary) somnolence, increased appetite, and/or diarrhoea." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for smoking, cessation?

"[Pregnant patients] were more likely to take advantage of this important opportunity to improve birth outcomes in women who smoke than nonpregnant smokers and women who do not smoke." - Anonymous Online Contributor

Unverified Answer

Has nicotine lozenge proven to be more effective than a placebo?

"Subjects receiving a lozenge tended to have a shorter lapse, and more successful quitters, than those receiving a placebo. Lozenges are effective for maintaining cessation. Nicotine lozenges are more effective than a placebo in the short term." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving nicotine lozenge?

"Nicotine lozenge is not approved for use in Canada. Current clinical trials are not powered to demonstrate whether this product will be effective in the management of smoking cessation. If they are approved by this Agency, nicotine lozenges will then be regulated similarly to nicotine gums (see http://www.canada.gc.ca/rgs/health/products/product.aspx?code=268045)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Smoking, Cessation by sharing your contact details with the study coordinator.