Smoking Cessation Clinical Trial
Official title:
Testing the Efficacy of A Scalable, Telephone-Delivered, Guided Imagery Tobacco Cessation Intervention
The objective of this R01 application is to conduct a randomized controlled trial to test the efficacy of the Be Smoke Free, telephone-based, guided imagery (GI) intervention (IC) for smoking cessation compared to active behavioral control (CC). The study will recruit 1,200 diverse smokers from three states, Arizona, New York, and West Virginia to increase generalizability. Participants will be randomly assigned to receive either the IC or CC delivered by telephone by University of Arizona study coaches and will be assessed at 3- and 6-months post-enrollment by study staff. The primary outcome is biochemically verified 7-day point prevalence abstinence at 6 months. This innovative and rigorously designed project conducted by an experienced team has the potential to improve public health through the delivery of an innovative integrative GI intervention via telephone.
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | August 31, 2026 |
Est. primary completion date | August 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Report daily smoking in the last 30 days - Age 18 or over - Speak English - Have a smart phone with internet access - Willing to receive coaching over the phone Exclusion Criteria: - No phone - No internet access - Does not speak English - More than one person per household - Psychosis |
Country | Name | City | State |
---|---|---|---|
United States | University of Arizona | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Arizona | National Center for Complementary and Integrative Health (NCCIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants who achieve biochemically verified 7 day smoking abstinence | Smoking abstinence will be biochemically verified with expired carbon monoxide | 6 months | |
Secondary | Number of participants who report 7 day smoking abstinence | Participants will self-report tobacco use | Baseline, 3 months, and 6 months | |
Secondary | Number of participants who report 30 day smoking abstinence | Participants will self-report tobacco use | Baseline, 3 months, and 6 months | |
Secondary | Number of minutes of intervention use per week | Number of minutes participants engage in study sessions per week | Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | |
Secondary | Number of minutes guided imagery and other integrative skills practiced per day | Participants will self-report number of minutes guided imagery and other integrative skills practiced per day for the past 7 days | 3 months, 6 months | |
Secondary | Number of intervention sessions attended | Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 |
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 |
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 |
NCT02905656 -
Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit
|
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 |