COMPLETED

Combining Varenicline and Guanfacine for Smoking Cessation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The novel design of this study combines a laboratory paradigm to evaluate stress-induced smoking behavior and smoking-related reinforcement, followed by a 12-week treatment phase to evaluate clinical outcomes.

Official Title

Combining Varenicline and Guanfacine for Smoking Cessation

Quick Facts

Study Start:2020-11-01

Study Completion:2025-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04198116

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18+ 2. Able to read and write English 3. SMOKER: 10 or more cigarettes per day for at least the past year, Carbon Monoxide (CO) \> 10 ppm at intake 4. Able to take oral medications and willing to adhere to medication regimen 5. Provide evidence of a stable living residence in the last 2 months prior to randomization, have reasonable transportation arrangements to the study site, have no plans to move within the next 3 months, and have no unresolved legal problems 6. Motivated to quit smoking (8 or greater on the Contemplation Ladder)	1. Subjects with any significant current medical conditions (neurological, cardiovascular \[including hypertension or hypotension: sitting BP \>160/100 or \<90/60mmHg at baseline screening\], endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions 2. Current Diagnostic and Statistical Manual of Mental Disorders (DSM-V) alcohol or substances use disorders, other than mild alcohol use disorder or tobacco use disorder 3. Subjects who have a positive test result at intake appointment on urine drug screens conducted for illicit drugs 4. Past 30 day use of psychoactive drugs excluding anxiolytics and antidepressants (however, see #10; barbiturates, benzodiazepines are exclusionary) 5. Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or IUD) 6. Suicidal, homicidal or evidence of current (past 6-month) severe mental illness such as schizophrenia or bipolar disorder 7. meeting DSM-V criteria for current (past-6 month) attention deficit hyperactivity disorder (ADHD) 8. Individuals who are currently taking medications known to be effective for smoking cessation (e.g., FDA smoking cessation medications, nortriptyline, clonidine) or are regular users of e-cigarettes or other tobacco projects (pipe, cigar, smokeless tobacco) in the past 30 days 9. Only one member per household can participate in the study 10. Specific exclusions for administration of guanfacine not already specified: EKG evidence at baseline screening of any clinically significant conduction abnormalities or arrhythmias; known intolerance for guanfacine or any alpha blocker; history of fainting, syncopal attacks, heart failure or myocardial infarction, or impaired liver (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\] \> 3x normal) or renal function (estimated creatinine clearance \<60 cc/min); treatment with any antihypertensive drug or any alpha-blocker; use of any central nervous system (CNS) depressant (e.g., phenothiazines, barbiturates, benzodiazepines) 11. Specific exclusions for the administration of varenicline not already specified: known intolerance to varenicline or taking H2blockers (e.g., Cimetidine), quinolones, or trimethoprim.

Inclusion Criteria

Exclusion Criteria

1. Age 18+
2. Able to read and write English
3. SMOKER: 10 or more cigarettes per day for at least the past year, Carbon Monoxide (CO) \> 10 ppm at intake
4. Able to take oral medications and willing to adhere to medication regimen
5. Provide evidence of a stable living residence in the last 2 months prior to randomization, have reasonable transportation arrangements to the study site, have no plans to move within the next 3 months, and have no unresolved legal problems
6. Motivated to quit smoking (8 or greater on the Contemplation Ladder)

1. Subjects with any significant current medical conditions (neurological, cardiovascular \[including hypertension or hypotension: sitting BP \>160/100 or \<90/60mmHg at baseline screening\], endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions
2. Current Diagnostic and Statistical Manual of Mental Disorders (DSM-V) alcohol or substances use disorders, other than mild alcohol use disorder or tobacco use disorder
3. Subjects who have a positive test result at intake appointment on urine drug screens conducted for illicit drugs
4. Past 30 day use of psychoactive drugs excluding anxiolytics and antidepressants (however, see #10; barbiturates, benzodiazepines are exclusionary)
5. Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or IUD)
6. Suicidal, homicidal or evidence of current (past 6-month) severe mental illness such as schizophrenia or bipolar disorder
7. meeting DSM-V criteria for current (past-6 month) attention deficit hyperactivity disorder (ADHD)
8. Individuals who are currently taking medications known to be effective for smoking cessation (e.g., FDA smoking cessation medications, nortriptyline, clonidine) or are regular users of e-cigarettes or other tobacco projects (pipe, cigar, smokeless tobacco) in the past 30 days
9. Only one member per household can participate in the study
10. Specific exclusions for administration of guanfacine not already specified: EKG evidence at baseline screening of any clinically significant conduction abnormalities or arrhythmias; known intolerance for guanfacine or any alpha blocker; history of fainting, syncopal attacks, heart failure or myocardial infarction, or impaired liver (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\] \> 3x normal) or renal function (estimated creatinine clearance \<60 cc/min); treatment with any antihypertensive drug or any alpha-blocker; use of any central nervous system (CNS) depressant (e.g., phenothiazines, barbiturates, benzodiazepines)
11. Specific exclusions for the administration of varenicline not already specified: known intolerance to varenicline or taking H2blockers (e.g., Cimetidine), quinolones, or trimethoprim.

Contacts and Locations

Principal Investigator

Sherry McKee, PhD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale University

New Haven, Connecticut, 06519

United States

Collaborators and Investigators

Sponsor: Yale University

Sherry McKee, PhD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-01

Study Completion Date2025-04-30

Study Record Updates

Study Start Date2020-11-01

Study Completion Date2025-04-30

Terms related to this study

Additional Relevant MeSH Terms

Smoking Cessation