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Long-acting nicotine replacement therapy for Cancer

Kings Daughters Medical Center - Ashland, Ashland, KY
Cancer+1 More ConditionsLong-acting nicotine replacement therapy - Drug
Eligibility
18+
All Sexes

Study Summary

This trial will test different smoking cessation strategies to see which one is most effective for patients receiving treatment for tobacco-related cancer.

Eligible Conditions
  • Treatment-Related Cancer
  • Smoking Cessation

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Nicotine Replacement
2
Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)
3
Nicotine patch

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 6 months

6 months
Change in Cigarette Use
Counselling Compliance
Drug Compliance
Insurance coverage
Number of patients requiring financial assistance with medication.
Number of patients with alteration in therapy
Prevalence of cigarette use
at baseline
Preferred treatment
at week 8
Proportion of participants that quit smoking.

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Nicotine Replacement
3
Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)
3
Nicotine patch

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

12 Treatment Groups

Group 1: Varenicline, Intense Counselling and NRT
1 of 12
Group : Varenicline, Intense Counselling
1 of 12
Group 3: Varenicline, Minimal Counselling and NRT
1 of 12
Group 4: Varenicline, Minimal Counselling
1 of 12
Group 5: Buproprion, Intense Counselling and NRT
1 of 12
Group 6: Buproprion, Intense Counselling
1 of 12
Group 7: Buproprion, Minimal Counselling and NRT
1 of 12
Group 8: Buproprion, Minimal Counselling
1 of 12
Group 9: Nicotine, Intense Counselling and NRT
1 of 12
Group 10: Nicotine, Intense Counselling
1 of 12
Group 11: Nicotine, Minimal Counselling and NRT
1 of 12
Group 12: Nicotine, Minimal Counselling
1 of 12

Experimental Treatment

96 Total Participants · 12 Treatment Groups

Primary Treatment: Long-acting nicotine replacement therapy · No Placebo Group · Phase 2

Group 1: Varenicline, Intense Counselling and NRTExperimental Group · 3 Interventions: Nicotine Replacement Products, Varenicline, High-intensity counseling · Intervention Types: Drug, Drug, Behavioral
Group : Varenicline, Intense CounsellingExperimental Group · 3 Interventions: No nicotine replacement therapy, Varenicline, High-intensity counseling · Intervention Types: Other, Drug, Behavioral
Group 3: Varenicline, Minimal Counselling and NRTExperimental Group · 3 Interventions: Nicotine Replacement Products, Varenicline, Low-intensity counseling · Intervention Types: Drug, Drug, Behavioral
Group 4: Varenicline, Minimal CounsellingExperimental Group · 3 Interventions: No nicotine replacement therapy, Varenicline, Low-intensity counseling · Intervention Types: Other, Drug, Behavioral
Group 5: Buproprion, Intense Counselling and NRTExperimental Group · 3 Interventions: Nicotine Replacement Products, Bupropion, High-intensity counseling · Intervention Types: Drug, Drug, Behavioral
Group 6: Buproprion, Intense CounsellingExperimental Group · 3 Interventions: No nicotine replacement therapy, Bupropion, High-intensity counseling · Intervention Types: Other, Drug, Behavioral
Group 7: Buproprion, Minimal Counselling and NRTExperimental Group · 3 Interventions: Nicotine Replacement Products, Bupropion, Low-intensity counseling · Intervention Types: Drug, Drug, Behavioral
Group 8: Buproprion, Minimal CounsellingExperimental Group · 3 Interventions: No nicotine replacement therapy, Bupropion, Low-intensity counseling · Intervention Types: Other, Drug, Behavioral
Group 9: Nicotine, Intense Counselling and NRTExperimental Group · 3 Interventions: Nicotine Replacement Products, Long-acting nicotine replacement therapy, High-intensity counseling · Intervention Types: Drug, Drug, Behavioral
Group 10: Nicotine, Intense CounsellingExperimental Group · 3 Interventions: No nicotine replacement therapy, Long-acting nicotine replacement therapy, High-intensity counseling · Intervention Types: Other, Drug, Behavioral
Group 11: Nicotine, Minimal Counselling and NRTExperimental Group · 3 Interventions: Nicotine Replacement Products, Long-acting nicotine replacement therapy, Low-intensity counseling · Intervention Types: Drug, Drug, Behavioral
Group 12: Nicotine, Minimal CounsellingExperimental Group · 3 Interventions: No nicotine replacement therapy, Long-acting nicotine replacement therapy, Low-intensity counseling · Intervention Types: Other, Drug, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupropion
FDA approved
Varenicline
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

Joseph Valentino, MDLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You smoked a cigarette within a month of being diagnosed with cancer.
You have smoked a cigarette within the past 4 weeks before the study.
You have smoked cigarettes for at least 10 years.
You are expected to live for at least one more year.
References

Frequently Asked Questions

Have prior investigations been conducted into High-intensity counseling?

"Presently, 113 trials are ongoing in regards to High-intensity counselling. Of these studies, 17 have progressed to Phase 3 status. The majority of the investigations related to this therapeutic approach is occurring in Charleston, South Carolina; nonetheless there are 530 distinct sites conducting research into it." - Anonymous Online Contributor

Unverified Answer

Is High-intensity counseling a risk-free intervention for individuals?

"Although there is anecdotal evidence of this intervention's safety, without any proof of efficacy the score for High-intensity counseling was 2 out of 3." - Anonymous Online Contributor

Unverified Answer

To what sort of conditions is High-intensity counseling commonly recommended?

"High-intensity counseling is mainly used for treating ADHD, but has had success in managing Seasonal Affective Disorder, ceasing smoking habits and aiding with nicotine addiction." - Anonymous Online Contributor

Unverified Answer

Is this research endeavor actively seeking participants?

"This trial is actively recruiting, as reported on clinicaltrials.gov. The study was published to the registry on December 1st 2021 and then updated just last month (February 9th 2022)." - Anonymous Online Contributor

Unverified Answer

What is the current sample size for this clinical investigation?

"Affirmative. Clinicaltrials.gov reports verify that this medical research, which was initially announced on December 1st 2021, is actively recruiting participants. A total of 96 individuals are needed from one centre." - 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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