Personalized treatments for quitting smoking

PISCES I: Precision Implemented Smoking Cessation Evaluation Study

This study tests different personalized ways to help people quit smoking by matching treatments like counseling and medications to their individual needs.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2010 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT04604509 on ClinicalTrials.gov

What this trial studies

This phase IV trial investigates how to tailor smoking cessation treatments, including nicotine replacement therapy, counseling, and medications like varenicline and bupropion, based on individual characteristics. Participants are randomized into groups to receive different treatment regimens, with the aim of identifying effective personalized approaches for those struggling to quit smoking. The study also aims to develop a predictive algorithm to estimate the likelihood of quitting smoking based on baseline characteristics. This research could enhance the effectiveness of smoking cessation strategies.

Who should consider this trial

Good fit: Ideal candidates are individuals who smoke at least 5 cigarettes per day and are interested in quitting smoking.

Not a fit: Patients who do not reside in Texas or those who are not currently smoking may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective, personalized smoking cessation treatments that improve quit rates.

How similar studies have performed: Other studies have shown promise in personalized approaches to smoking cessation, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
  * Certain medications may be exclusionary and others are precautionary, to be evaluated on a case-by-case basis by study physician (See Exclusionary/Precautionary Medication List, Appendix 5)
  * Daily use of opioids for 30 days or more on phone screen or at screening is exclusionary, however as needed (PRN) use is allowed (i.e., 3 out of 7 days per week or less or if more frequent use in less than a month's duration)
* 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

Where this trial is running

Houston, Texas

• M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Jason Robinson — M.D. Anderson Cancer Center
• Study coordinator: Jason Robinson, PHD

Conditions Cigarette Smoking-Related Carcinoma