Nicotine Patch for Tobacco Dependence

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Centre for Addiction and Mental Health, Toronto, Canada
Tobacco Dependence+1 More
Nicotine Patch - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a personalized dose of nicotine patch will improve quitting success in those who do not respond to a standard dose of nicotine replacement therapy.

See full description

Eligible Conditions

  • Tobacco Dependence
  • Nicotine Dependence

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Tobacco Dependence

Study Objectives

This trial is evaluating whether Nicotine Patch will improve 1 primary outcome and 1 secondary outcome in patients with Tobacco Dependence. Measurement will happen over the course of weeks 9-52.

weeks 9 to 12
Short term continuous abstinence
weeks 9-52
Long term continuous abstinence

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Tobacco Dependence

Trial Design

3 Treatment Groups

Quit condition
1 of 3
Experimental Condition
1 of 3
Placebo Condition
1 of 3
Active Control
Experimental Treatment
Non-Treatment Group

This trial requires 500 total participants across 3 different treatment groups

This trial involves 3 different treatments. Nicotine Patch is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Experimental Condition
Drug
Participants unable to quit smoking after 2 weeks of treatment with 21mg nicotine patch will get 21mg nicotine patches plus additional active nicotine patches until achieving 7 consecutive days of abstinence over the next 5 weeks; maximum daily patch dose, 84mg/day
Quit condition
Drug
Participants able to quit for 7 consecutive days during the first 2 weeks of treatment with 21mg nicotine patch will continue open label 21mg active nicotine patches for the remaining 10 weeks.
Placebo ConditionParticipant unable to quit smoking after 2 weeks of treatment with 21mg nicotine patch will get 21mg nicotine patches plus placebo patches until 7 consecutive days of abstinence over the next 5 weeks; Maximum daily patch dose, 21mg active nicotine patch plus 3 placebo 21mg patches.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 9 to 12
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly weeks 9 to 12 for reporting.

Who is running the study

Principal Investigator
L. Z.
Laurie Zawertailo, Senior Scientist
Centre for Addiction and Mental Health

Closest Location

Centre for Addiction and Mental Health - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Daily tobacco smoker of ≥10 cigarettes per day
Aged 18 to 75 years old
Interested in using tNRT as the only smoking cessation aid
Intending to quit smoking within the next 30 days

Patient Q&A Section

What are common treatments for tobacco dependence?

"Recent findings of treatment of tobacco dependence found that medication is more common than CBT, with a growing use of smoking cessation medication such as bupropion. CBT is often used in conjunction with medication, with and without medication. Although these findings may be limited by sample size, they provide insights about treatment methods for tobacco dependence." - Anonymous Online Contributor

Unverified Answer

How many people get tobacco dependence a year in the United States?

"Nearly 37 million Americans currently use tobacco regularly. This amount is higher than that in the 1980s and is increasing over time. The higher prevalence of adolescent dependence on tobacco among Latino youth also highlights significant prevention efforts that could substantially help control tobacco use in the United States." - Anonymous Online Contributor

Unverified Answer

What is tobacco dependence?

"There are three specific smoking withdrawal symptoms and patterns: (1) gradual withdrawal in >60% of smokers, sometimes with withdrawal symptoms; (2) abrupt cessation, usually accompanied by severe withdrawal, occasionally followed by rebound; and (3) persistent dependence; the pattern of relapse depends substantially on the initial dose, duration of treatment, and pattern of abstinence." - Anonymous Online Contributor

Unverified Answer

What are the signs of tobacco dependence?

"Significant behavioral or psychological symptoms that could predict nicotine dependence include: lack of control over use, trouble with social or occupational functioning, and psychological problems (i.e., depression or anxiety). These symptoms typically appear early in tobacco use, are often exacerbated by nicotine administration, and are more severe in pre-twenties and thirties than in young teens or young adults." - Anonymous Online Contributor

Unverified Answer

Can tobacco dependence be cured?

"For patients experiencing nicotine withdrawal syndrome or the subjective experience of smokeless tobacco dependence, the withdrawal is more often resolved or alleviated by pharmacological, or psychotherapeutic means than by a smoking cessation program. For patients with an objective degree of dependence assessed primarily through a craving questionnaire, however, smoking cessation appears to be less successful." - Anonymous Online Contributor

Unverified Answer

What causes tobacco dependence?

"Recent findings suggest that (1) the biological basis of tobacco dependence is a complex process; (2) the biological basis explains only about a third of the variability that exists in the manifestation of dependence, and it is possible to predict dependence by considering other variables, such as the frequency of smoking or a history of smoking before adolescence; (3) only a subgroup of individuals is susceptible to dependence, such that the ability to avoid dependence depends on others' willingness to accept (withdraw) from their smoking habit." - Anonymous Online Contributor

Unverified Answer

Is nicotine patch typically used in combination with any other treatments?

"The combination with NRT plus NRT was the most common. NRT with a nicotine cigarette (NicDelt) is only available in the Netherlands and Belgium. We found that more than 30% of our patients still used an NRT combined with medication. This could have resulted in greater nicotine delivery to the body and less side effect. Therefore, the use of NRT combined with NRT might provide a higher and less risky maintenance of abstinence from tobacco. Further research is warranted." - Anonymous Online Contributor

Unverified Answer

Does tobacco dependence run in families?

"Tobacco dependence in family members is strongly influenced by factors other than genetic disposition. The identification of new factors may help us to further understand the etiologic pathogenesis of tobacco dependence." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of nicotine patch?

"Side effects are common among all populations who use patch therapy. For patients with any of the common side effects, this study demonstrates the patch has less impact on patient-reported QlQ improvements than expected. However, the patch does seem to have some influence on QQ-28 improvements." - Anonymous Online Contributor

Unverified Answer

What is the latest research for tobacco dependence?

"In the last century, tobacco dependence has been identified as an important public issue because most people who become addicted will dependence become dependent for life. It is the leading cause of preventable death and disability in the US and the UK, and this is [an underestimate] of the scope, burden and cost of this issue as well as the lack of effective prevention and treatment." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of tobacco dependence?

"The present study establishes that there is a direct relationship between the degree of dependence on tobacco products and tobacco use in the past, the intensity of the dependence and the degree of addiction to tobacco at the date of survey. It also provides evidence in support of the hypothesis of dependence mediated by reinforcing effects of nicotine, as already reported in other researches." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in nicotine patch for therapeutic use?

"The nicotine patch for therapeutic use has been found ineffective as a nicotine replacement. It has also been found that nicotine patches can increase the desire and craving for nonnicotine reinforcers in addition to withdrawal from nicotine." - 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.
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