Smoking Cessation Clinical Trial
Official title:
Adaptation and Initial Evaluation of Transdiagnostic CBT for Anxious and Depressed Smokers
This study will look at the effectiveness of a new treatment protocol for anxious and depressed smokers. Participants with clinically significant anxiety or depression will receive either the standard smoking cessation treatment or the Unified Protocol for Smoking Cessation Treatment. This study will demonstrate that a single treatment protocol can effectively address both smoking and the complex emotional comorbidities that are widespread in smokers will provide a novel, impactful, and highly disseminable treatment option missing from today's smoking cessation arsenal.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | February 2024 |
Est. primary completion date | July 26, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Inclusion criteria for the study include 1) being 18-65 years of age, 2) daily smoking of at least 5 cigarettes per day for at least one year and biochemically confirmed at least 10 ppm at baseline. Participants must be 3) motivated to quit smoking in the next month 4) have clinically significant anxiety or depression defined as >=8 on the OASIS or ODIS, 5) must be willing and able to attend all the appointments, and 6) must be willing to quit smoking as the sixth treatment session. Exclusion Criteria: - Exclusion criteria include 1) Use of other tobacco products 2) Report of current or intended participation in a concurrent substance abuse treatment, 3) Ongoing psychotherapy of any duration targeting anxiety or depression, 4) Current non-nicotine substance dependence, 5) Not being fluent in English, 6) Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers, 7) Legal status that will interfere with participation, 8) Positive pregnancy test at baseline, 9) Active suicidality (i.e., suicidal ideation, intent, and/or plan) or current psychosis. |
Country | Name | City | State |
---|---|---|---|
United States | University of Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Houston |
United States,
National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. The Health Consequences of Smoking-50 Years of Progress: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK179276/ — View Citation
Zvolensky MJ, Jardin C, Wall MM, Gbedemah M, Hasin D, Shankman SA, Gallagher MW, Bakhshaie J, Goodwin RD. Psychological Distress Among Smokers in the United States: 2008-2014. Nicotine Tob Res. 2018 May 3;20(6):707-713. doi: 10.1093/ntr/ntx099. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short- and long-term point prevalence abstinence (PPA). | In three separate follow up appointments, one 3 months after the end of treatments, one 6 months after and one 12 months after, The investigators will ask participants various questions about their abstinence. The investigators will measure the length of time between when treatment ends and when/ if they start smoking again. The unit of measure will be length of time in days. The investigators expect that point prevalence abstinence will be higher, both in the short term and long term, in the UP-ST condition than in the ST condition. Similarly, The investigators expect the rate of decline in abstinence over time to be shallower (smaller) in UP-ST than in ST. | 12 months | |
Secondary | Tobacco withdrawal | In three separate follow up appointments 3, 6 and 12 months after the end of treatment, The investigators will administer a survey to participants. The survey will assess withdrawal symptoms. Participants will score this condition on a scale from 0-10. 10 meaning extremely severe and 0 meaning not at all. The investigators expect the mean score to be higher in the ST condition than the UP-ST condition at all time points. | 12 months | |
Secondary | Time to first smoking lapse and time to relapse | The investigators will ask participants to record the time (in days) of their first (if any) lapse in smoking and their relapse. The investigators will take an average for control and active participants and The investigators expect mean time to first lapse and to relapse to be greater for those in the UP-ST compared to those in the ST condition. | 12 months | |
Secondary | Tobacco craving | In three separate follow up appointments 3, 6 and 12 months after the end of treatment, The investigators will administer a survey to participants. The survey will assess tobacco craving. Participants will score this condition on a scale from 0-10. 10 meaning extremely severe and 0 meaning not at all. The investigators expect the mean score to be higher in the ST condition than the UP-ST condition at all time points. | 12 months | |
Secondary | Tobacco dependence | In three separate follow up appointments 3, 6 and 12 months after the end of treatment, The investigators will administer a survey to participants. The survey will assess tobacco dependence. Participants will score this condition on a scale from 0-10. 10 meaning extremely severe and 0 meaning not at all. The investigators expect the mean score to be higher in the ST condition than the UP-ST condition at all time points. | 12 months |
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 |
NCT02239770 -
Pharmacokinetics of Nicotine Film in Smokers
|
N/A | |
Completed |
NCT02562521 -
A Smoking Cessation Intervention for Yale Dining Employees
|
Phase 4 | |
Recruiting |
NCT02422914 -
Benefits of Tobacco Free Cigarette
|
N/A |