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Antidepressant
Smoking Cessation Therapies for Quitting Smoking
Phase 4
Recruiting
Led By Paul Cinciripini
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Psychiatric hospitalization within 1 year of screening date
Being pregnant, engaging in breast-feeding, or being of childbearing potential and engaging in sexual activity that could lead to pregnancy and is not protected by a medically acceptable, effective method of birth control while enrolled in the study, as determined by self-report. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Summary
This trial is testing how to best help people quit smoking, based on their individual character traits.
Who is the study for?
This trial is for Texas residents who smoke at least 5 cigarettes a day, want to quit or change their smoking habits, and can be reached by phone. They must agree to telehealth treatment and not use other nicotine products during the study. Pregnant women, those with serious medical/psychiatric issues, or using certain medications are excluded.
What is being tested?
The PISCES I Trial is testing personalized treatments for quitting smoking in cancer patients. It includes nicotine replacement therapy, counseling, and medications like varenicline and bupropion. The goal is to find out which combination of these methods works best based on individual characteristics.
What are the potential side effects?
Possible side effects from the treatments may include nausea, headaches, trouble sleeping (insomnia), dry mouth for medication like bupropion; skin irritation from patches or gum problems from nicotine replacement; mood changes or vivid dreams with varenicline.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not been hospitalized for psychiatric reasons in the last year.
Select...
I am not pregnant, breastfeeding, or at risk of becoming pregnant because I use effective birth control.
Select...
I have severe anxiety or panic syndrome according to the GAD-7 or PHQ Panic module.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Abstinence
End of treatment seven-day point prevalence
Expired carbon monoxide value
Secondary study objectives
Days to relapse
Trial Design
7Treatment groups
Experimental Treatment
Group I: Group VII (varenicline and NRT, counseling)Experimental Treatment4 Interventions
Participants receive varenicline as in Group I and NRT as in Group II for 6 weeks. Participants also receive behavioral smoking cessation counseling.
Group II: Group VI (varenicline or NRT, bupropion, counseling)Experimental Treatment5 Interventions
Participants continue to receive varenicline as in Group I or NRT as in Group II for 6 weeks depending on which group they were assigned to. Participants also receive bupropion PO daily for 6 weeks and behavioral smoking cessation counseling.
Group III: Group V (higher dose varenicline or NRT, counseling)Experimental Treatment4 Interventions
Participants receive a higher dose and continue to receive varenicline as in Group I or NRT as in Group II for 6 weeks depending on which group they were assigned to. Participants also receive behavioral smoking cessation counseling.
Group IV: Group IV (varenicline or NRT, counseling)Experimental Treatment4 Interventions
Participants switch to a different therapy and receive varenicline as in Group I or NRT as in Group II for 6 weeks depending on which group they were assigned to. Participants also receive behavioral smoking cessation counseling.
Group V: Group III (varenicline or NRT, counseling)Experimental Treatment4 Interventions
Participants continue to receive varenicline as in Group I or NRT as in Group II for 6 additional weeks depending on which group they were assigned to. Participants also receive behavioral smoking cessation counseling.
Group VI: Group II (NRT, counseling)Experimental Treatment3 Interventions
Participants receive NRT consisting of a patch, lozenges, or gum daily for 6 weeks in the absence of unacceptable toxicity. Participants who quit smoking continue treatment for 6 additional weeks in the absence of unacceptable toxicity. Participants also receive behavioral smoking cessation counseling.
Group VII: Group I (varenicline, counseling)Experimental Treatment3 Interventions
Participants receive varenicline PO daily or BID for 6 weeks in the absence of unacceptable toxicity. Participants who quit smoking continue treatment for 6 additional weeks in the absence of unacceptable toxicity. Participants also receive behavioral smoking cessation counseling.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved
Varenicline
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,797,691 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,000,990 Total Patients Enrolled
Paul CinciripiniPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
1,011 Total Patients Enrolled
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