Smoking Cessation Clinical Trial
Official title:
Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain
Verified date | May 2024 |
Source | Abramson Cancer Center at Penn Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to better understand (1) why people gain weight when they quit smoking and (2) whether certain types of smoking cessation (i.e. quit smoking) counseling combined with the nicotine patch help people quit smoking and gain less weight.
Status | Completed |
Enrollment | 288 |
Est. completion date | February 28, 2021 |
Est. primary completion date | February 28, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Male and female treatment-seeking smokers who are between 18 and 65 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months. - Plan to live in the area for the duration of the study (i.e. ~30 weeks/8 months). - Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form. - Smokers who wish to make a permanent quit attempt in the next 1-2 months (treatment-seeking), because our prior work suggests that motivated subjects are more sensitive to medication effects on smoking behavior. - Able to communicate fluently in English (i.e. speaking, writing, and reading). - Provide a Carbon Monoxide (CO) breath test reading greater than or equal to 5 parts per million (ppm) at the Intake Visit. Exclusion Criteria: Smoking Behavior. - Regular use of nicotine containing products other than cigarettes (e.g. chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Participants agreeing to abstain from using nicotine containing products other than cigarettes and the study-provided TN for the duration of trial will be considered eligible. - Current enrollment or plans to enroll in another research and/or smoking cessation program over the duration of the study (i.e. ~30 weeks/8 months). - Anticipated use (within the next ~30 weeks/8 months) of any nicotine substitutes and/or smoking cessation treatments/medications unless provided through the study. - Provide a CO breath test reading less than 8 ppm at Intake Visit. Alcohol and Drug. - History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse. Counseling and support groups (e.g. Alcoholics Anonymous and Narcotics Anonymous) will not be considered medical treatment for the purposes of this protocol. - Current alcohol consumption that exceeds 25 standard drinks/week. - Breath alcohol reading (BrAC) greater than .000 at the Intake Visit. - A positive urine drug screen (UDS) for cocaine, opiates, amphetamines, methamphetamines, phencyclidine (PCP), ecstasy (MDMA), barbiturates, benzodiazepines, methadone, and/or oxycodone at the Intake Visit. Medical. - Women who are pregnant, breast feeding, or planning a pregnancy over the duration of the study period. Women must agree to use an adequate form of contraception or abstain from sexual intercourse for the duration and for at least one month after the end of the study. - Current treatment of cancer or diagnosed with cancer (except basal or squamous-cell carcinoma not treated with chemotherapy and/or radiation) in the past 6 months. - Poorly controlled, brittle, or pump-dependent Type I diabetes. - Current peptic ulcer bleeding. - Allergy to adhesive tape. - Skin problems or sensitivities. Eligibility will be evaluated on a case-by-case basis by the Study Physician. - Active hepatitis or poorly controlled kidney and/or liver disease. - Uncontrolled hypertension (systolic blood pressure [SBP] greater than 159 and/or diastolic blood pressure [DBP] greater than 99 - History of abnormal heart rhythms, tachycardia, and/or cardiovascular disease (e.g. stroke, angina, heart attack) may result in ineligibility. These conditions will be evaluated on a case-by-case basis by the Study Physician. - History of epilepsy or seizures. Eligibility will be evaluated on a case-by-case basis by the Study Physician. - Serious or unstable disease within the past 6 months. Notable diseases will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician. - Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing proper completion of the study procedures. Notable impairments will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician. - Low or borderline intellectual functioning - determined by receiving a score of less than 75 on the Shipley Institute of Living Scale (SILS), which correlates with the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Estimated Intelligence Quotient (IQ) Test. - Applicable food allergies or disorders: Galactosemia, Notable milk allergy (lactose intolerant participants may proceed unless they experience severe symptoms), Notable soy allergy, Peanut allergy Psychiatric. - Current diagnosis of major depression. Subjects with a history of major depression, in remission for 6 months or longer (may be stable on antidepressant medications), are eligible. - Lifetime history of a suicide attempt. - Lifetime history of schizophrenia, psychosis, and/or bipolar disorder. Medication. Current use or recent discontinuation (within the last 14 days) of: - Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin Standard-Release, Chantix). - Anti-psychotic medications. - Prescription stimulants (e.g., Provigil, Ritalin, Adderall). - Systemic steroids. Current use of: - Nicotine replacement therapy (NRT). - Heart medications such as digoxin, quinidine, and nitroglycerin. Daily use of: - Opiate-containing medications for chronic pain. - Inhaled corticosteroids. - Benzodiazepines and/or Barbiturates. General Exclusion. - Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal Investigator and/or Study Physician. - Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen. - Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible at any point throughout the study. - Subjects failing to complete an in-person Baseline Visit will be excluded (no Principal Investigator determination required). |
Country | Name | City | State |
---|---|---|---|
United States | Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center at Penn Medicine | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Smoking Cessation | Smoking abstinence (primary outcome) will be assessed and biochemically verified at the End of Treatment Visit (week 8), at 12 and 26 weeks after the target quit date. The primary smoking outcome variable will be 7-day point prevalence abstinence (no smoking, not even a puff, for at least 7 days prior to the assessment) biochemically verified by CO < 5 ppm at End of Treatment (week 8), and by saliva cotinine < 15ng/ml at the 12- and 26-week follow-up. | Through Study Completion (End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit) | |
Primary | Weight Change | Weight will be measured by a physician's scale (pounds) at the beginning of every in-person visit through study completion. Participants will be wearing light clothing without shoes. Pre-cessation weight will be computed as the average of weights at the Intake and Baseline Visits prior to any change in smoking behavior. Weight change from Baseline to the 26-week follow-up will serve as a primary weight outcome variable. | Through Study Completion (Intake Visit, Baseline Visit, Pre-Quit Visit , Target Quit Date Visit, Mid-Tx. 1 Visit, Mid-Tx 2 Visit, Mid-Tx 3 Visit, Mid-Tx 4 Visit , End of Treatment, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit) | |
Primary | Sub-Study: Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date | Smoking abstinence was assessed and biochemically verified at the 12-week Follow-Up Visit (12 weeks post target quit date). Seven-day point prevalence abstinence (no smoking, not even a puff for the last 7 days prior to the assessment) was biochemically verified by a carbon monoxide (CO) reading <8 parts per million. | 12-Week Follow-Up Visit | |
Secondary | Food Intake | Food intake (secondary outcome) will be assessed via 3 telephone-administered, 24-hour dietary recalls during the week after (or near) the Baseline Visit, Mid-Treatment 3 Visit (week 4), End of Treatment Visit (week 8) and the 12-week and 26-week follow-up Visits (n=15). A trained member of the research staff will use a multi-pass method with an interactive computerized software program, the Automated Self-Administered 24-hour Recall (ASA24®), to determine total kcal/day (outcome variable). | Through Study Completion (Baseline Visit, Mid-Tx 3 Visit, End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit) | |
Secondary | Sub-Study: fMRI BOLD Signal Change | T2*-weighted Blood Oxygen-Level-Dependent (BOLD) images will be acquired using a wholebrain, single-shot gradient-echo (GE) echo-planar imaging (EPI) sequence. BOLD images were captured (and subsequently analyzed) while participants complete a Food Cue-Induced Craving, Relative Reinforcing Value of Food, and Working Memory task inside the MRI Scanner. | Pre-Treatment fMRI Scan (~week 2), End of Treatment MRI Scan (~week 8) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
Completed |
NCT03999411 -
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
|
Phase 4 | |
Completed |
NCT04617444 -
The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function
|
N/A | |
Completed |
NCT02796391 -
Facilitating Smoking Cessation With Reduced Nicotine Cigarettes
|
Phase 2 | |
Completed |
NCT03397511 -
Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City
|
N/A | |
Not yet recruiting |
NCT05188287 -
A Culturally Tailored Smartphone Application for African American Smokers
|
N/A | |
Recruiting |
NCT05264428 -
The Effect of Honey on Lessening the Withdrawal Symptoms
|
N/A | |
Recruiting |
NCT05846841 -
Personalized Tobacco Treatment in Primary Care (MOTIVATE)
|
N/A | |
Completed |
NCT04133064 -
Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study
|
N/A | |
Completed |
NCT03187730 -
Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants
|
Phase 4 | |
Completed |
NCT03474783 -
To Explore the Factors Affecting the Effectiveness of Smoking Cessation
|
N/A | |
Completed |
NCT04635358 -
Feasibility Study of Smoking Cessation for the Staff of a Hospital Center
|
N/A | |
Terminated |
NCT03670264 -
BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation
|
N/A | |
Not yet recruiting |
NCT06307496 -
VIDeOS for Smoking Cessation
|
N/A | |
Completed |
NCT02905656 -
Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit
|
N/A | |
Completed |
NCT03206619 -
A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
|
||
Completed |
NCT02997657 -
Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT02562521 -
A Smoking Cessation Intervention for Yale Dining Employees
|
Phase 4 | |
Completed |
NCT02239770 -
Pharmacokinetics of Nicotine Film in Smokers
|
N/A | |
Recruiting |
NCT02422914 -
Benefits of Tobacco Free Cigarette
|
N/A |