Nicotine Replacement Therapy, Counseling, Varenicline, and Bupropion for Smoking Cessation, the PISCES I Trial

NCT04604509 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 2019-0953NCI-2020-05745
• Study Type: interventional
• Target: 2,010
• Locations: 1 country
• Sites: 1

Brief Summary

This phase IV trial investigates how to personalize treatments (such as medications and/or counseling) for quitting smoking based on the unique character traits of participants. Nicotine replacement therapy, counseling, and/or drugs such as varenicline and bupropion may help participants quit smoking or change smoking behavior. This trial may also help doctors individualize smoking cessation treatment for participants who do not quit smoking after the first course of treatment.

Conditions

Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (3)

• End of treatment seven-day point prevalence

  Will use Bayesian statistical methods to estimate these effects and their accompanying posterior probabilities.

  Up to 6 months

• Expired carbon monoxide value

  Will use Bayesian statistical methods to estimate these effects and their accompanying posterior probabilities.

  Up to 6 months

• Abstinence

  Will evaluate utilizing a logistic regression model.

  At 12 weeks

Secondary Outcomes (1)

• Days to relapse

  Up to 6 months

Study Arms (7)

Group I (varenicline, counseling)

EXPERIMENTAL

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.

Other: Questionnaire Administration; Other: Tobacco Cessation Counseling; Drug: Varenicline

Group II (NRT, counseling)

EXPERIMENTAL

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.

Drug: Nicotine Replacement; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling

Group III (varenicline or NRT, counseling)

EXPERIMENTAL

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.

Drug: Nicotine Replacement; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling; Drug: Varenicline

Group IV (varenicline or NRT, counseling)

EXPERIMENTAL

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.

Drug: Nicotine Replacement; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling; Drug: Varenicline

Group V (higher dose varenicline or NRT, counseling)

EXPERIMENTAL

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.

Drug: Nicotine Replacement; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling; Drug: Varenicline

Group VI (varenicline or NRT, bupropion, counseling)

EXPERIMENTAL

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.

Drug: Bupropion Hydrochloride Controlled-release; Drug: Nicotine Replacement; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling; Drug: Varenicline

Group VII (varenicline and NRT, counseling)

EXPERIMENTAL

Participants receive varenicline as in Group I and NRT as in Group II for 6 weeks. Participants also receive behavioral smoking cessation counseling.

Drug: Nicotine Replacement; Other: Questionnaire Administration; Other: Tobacco Cessation Counseling; Drug: Varenicline

Interventions

Bupropion Hydrochloride Controlled-release DRUG

Given PO

Also known as: Bupropion HCl Controlled-release, Bupropion HCl Extended Release, Bupropion Hydrochloride Extended-Release, Forfivo XL, Wellbutrin SR, Wellbutrin XL, Zyban

Group VI (varenicline or NRT, bupropion, counseling)

Nicotine Replacement DRUG

Given via nicotine patch, lozenges, or gum

Also known as: Nicotine Replacement Therapy, NRT

Group II (NRT, counseling); Group III (varenicline or NRT, counseling); Group IV (varenicline or NRT, counseling); Group V (higher dose varenicline or NRT, counseling); Group VI (varenicline or NRT, bupropion, counseling); Group VII (varenicline and NRT, counseling)

Questionnaire Administration OTHER

Ancillary studies

Group I (varenicline, counseling); Group II (NRT, counseling); Group III (varenicline or NRT, counseling); Group IV (varenicline or NRT, counseling); Group V (higher dose varenicline or NRT, counseling); Group VI (varenicline or NRT, bupropion, counseling); Group VII (varenicline and NRT, counseling)

Tobacco Cessation Counseling OTHER

Receive behavioral smoking cessation counseling

Group I (varenicline, counseling); Group II (NRT, counseling); Group III (varenicline or NRT, counseling); Group IV (varenicline or NRT, counseling); Group V (higher dose varenicline or NRT, counseling); Group VI (varenicline or NRT, bupropion, counseling); Group VII (varenicline and NRT, counseling)

Varenicline DRUG

Given PO

Also known as: Champix, Chantix, CP-526555

Group I (varenicline, counseling); Group III (varenicline or NRT, counseling); Group IV (varenicline or NRT, counseling); Group V (higher dose varenicline or NRT, counseling); Group VI (varenicline or NRT, bupropion, counseling); Group VII (varenicline and NRT, counseling)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smoking 5 or more cigarettes, little cigars and/or cigarillos per day, on average, within the past 30 days preceding the screening visit and expired carbon monoxide (CO) ≥ 6 ppm and/or a urine Nic Check test \> 0 (or a reading of positive if an alternate nicotine test used)
• Interested in treatment that might change smoking behavior or help them quit smoking
• Able to follow verbal and written instructions in English and complete all aspects of the study
• Provide informed consent and agree to all assessments and study procedures
• Have an address and telephone number where they may be reached
• Subjects must report current stable residence in the state of Texas and must not have plans to move out of state in the next 6 months. Stable residence is a domicile in which an individual can operate as if it were his or her own homestead and does not include shelters, halfway houses, treatment centers, or group homes
• Be the only participant in their household currently receiving treatment on this protocol
• Agree to be treated via telehealth (live audio-video conference and phone) and to be contacted via text and/or email
• Willing to refrain from the use of other nicotine/tobacco products for the duration of the study

You may not qualify if:

• Current enrollment or plans to enroll in another smoking cessation program during the study time frame, including plans to use other smoking cessation medications (i.e., over the counter \[OTC\] or prescription medication for smoking cessation) or smoking cessation treatments
• Serious or unstable medical or psychiatric disorder within the past 3 months, as determined by the study physician
• 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
• Current use of certain medications:
• Smoking cessation meds (last 7 days; e.g., bupropion, NRT, varenicline). Episodic use of NRT in the last 7 days may be considered if the participant agrees to only use study medication once randomized
• History of hypersensitivity or allergic reaction to varenicline, NRT, or any component of these formulations as determined by the medical team
• Self-report of a history or current diagnosis of schizophrenia or bipolar disorder unless cleared by study physician
• Current substance use disorder (Drug Abuse Screening Test \[DAST\] score \> 3 or use \>0 in the past year and refuses to refrain from use for the duration of the study; Alcohol Use Disorders Identification Test \[USAUDIT\] score \> 24)
• Individuals who report depressive symptoms in the moderately severe or severe range on the Patient Health Questionnaire - Mood Module (PHQ-9) (scores of 15 or above); or who report current suicidal ideation on the PHQ-9
• Individuals who report anxiety symptoms in the severe range on the Generalized Anxiety Disorder Scale (GAD-7) (scores of 15 or above); or meet criteria for panic syndrome on the PHQ Panic module
• Psychiatric hospitalization within 1 year of screening date
• Any otherwise not specified medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator and/or study physician
• Participant considered by the investigator as unsuitable candidate for full participation in both the treatment and follow-up phases of the study

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Interventions

Bupropion; Nicotine Replacement Therapy; Varenicline

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Drug Therapy; Therapeutics; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Jason Robinson

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Robinson, PHD

CONTACT

713-745-3822; nicotinestudy@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 27, 2020
• Study Start: August 4, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)