← Back to Search

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
Agree to be treated via telehealth (live audio-video conference and phone) and to be contacted via text and/or email
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I agree to telehealth appointments and to be contacted by text or email.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Abstinence
End of treatment seven-day point prevalence
Expired carbon monoxide value
Secondary outcome measures
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
2,958 Previous Clinical Trials
1,796,439 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,611 Previous Clinical Trials
40,914,004 Total Patients Enrolled
Paul CinciripiniPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
1,011 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any precedents of using Nicotine Substitutes to treat patients?

"At present, 113 clinical trials relating to Nicotine Replacement are currently being conducted with seventeen of them in the concluding Phase 3. A number of locations across America (530) are hosting these studies, many of which can be found in Charleston, South carolina."

Answered by AI

Are there any openings remaining for potential participants in this research project?

"Right, the data available on clinicaltrials.gov confirms that this medical research is actively engaging patients in its trial. It was first posted on August 4th 2020 and last edited on October 27th 2020; 2010 individuals need to be included from a single centre."

Answered by AI

What is the principal purpose of Nicotine Replacement Therapy?

"Nicotine Replacement is frequently implemented to help people with attention deficit hyperactivity disorder (ADHD) manage their symptoms. This treatment can also be utilized in the management of seasonal affective disorder, smoking cessation and smoke addiction."

Answered by AI

What is the cap on participant capacity in this experiment?

"Affirmative. Information on clinicaltrials.gov verifies that this medical trial, initially posted in August 4th 2020, is currently enrolling patients. Approximately 2010 individuals are required to be recruited from 1 healthcare facility."

Answered by AI

Has the FDA sanctioned Nicotine Replacement as a viable treatment option?

"Nicotine Replacement Therapy has already been approved, so it earned a rating of 3 in our safety assessment."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~720 spots leftby Mar 2026