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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

No Placebo-Only Group

Pivotal Trial

Approved for 5 Other Conditions

Drug Has Already Been Approved

All Individual Drugs Already Approved

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:

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I have not been hospitalized for psychiatric reasons in the last year.

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I am not pregnant, breastfeeding, or at risk of becoming pregnant because I use effective birth control.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

0 / 3Eligibility criteria met