BridgeMD
New treatment option for Cigarette Smoking-Related Carcinoma
Official title Nicotine Replacement Therapy, Counseling, Varenicline, and Bupropion for Smoking Cessation, the PISCES I Trial
ClinicalTrials.gov ID: NCT04604509
What this study is testing
What is Bupropion Hydrochloride Controlled-release?
Bupropion Hydrochloride Controlled-release is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for cigarette smoking-related carcinoma.
Also referred to as Bupropion HCl Controlled-release, Bupropion HCl Extended Release.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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
You likely can't join if
- Current enrollment or plans to enroll in another smoking cessation program during the study time frame, including plans to use other smoking...
- 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...
- 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...
- Certain medications may be exclusionary and others are precautionary, to be evaluated on a case-by-case basis by study physician (See...
See the full eligibility 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...
- 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
- people 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...
- 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
- 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...
- 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...
- 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 assigned by chance
- 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...
- 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]...
- 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...
- Participant considered by the investigator as unsuitable candidate for full participation in both the treatment and follow-up phases of the study
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.