Tobacco Use Clinical Trial
Official title:
Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
Verified date | June 2023 |
Source | H. Lee Moffitt Cancer Center and Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to develop a treatment that can effectively help people reduce their alcohol use and quit smoking.
Status | Completed |
Enrollment | 67 |
Est. completion date | November 4, 2021 |
Est. primary completion date | November 4, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria Aim 1: - 18 years of age or older - Currently smoking 3 or more cigarettes per day for the past year. - Carbon monoxide level >/= 8 ppm(parts per million); should carbon monoxide level yield a result less than 8 ppm, participant will be asked to submit a urine sample to determine contine levels and the result must be >/ level 3 - Participant must be motivated to quit smoking and decrease alcohol use within the next 60 days - If male, consume >/= 5 drinks and if female consume >/= 4 drinks on at least 1 occasion in the past month - Willing and able to attend the 8 weekly group sessions - Valid home address in the Tampa Bay area - Functioning telephone number - Can speak, read and write in English Inclusion Criteria Aim 2: - 18 years of age or older - Currently smoking 3 or more cigarettes per day for the past year. - Motivated to quit smoking and decrease alcohol use within the next 60 days - If male, consumes >/= 5 drinks and if female consumes >/= 4 drinks on at least 1 occasion in the past month - Willingness and ability to attend 8 weekly video group sessions - Willingness and ability to use an email account for study materials - Valid address - Functioning telephone number - Can speak, read and write in English Exclusion Criteria: - Unable to wear nicotine patch - Participants who have an active substance use disorder other than an alcohol use disorder - Participants who have an active psychotic disorder - Current use of tobacco cessation medications - Pregnant or nursing - Participants who have a household member already enrolled in the study. - In rare cases, study staff might exclude a participant for a reason not specified here |
Country | Name | City | State |
---|---|---|---|
United States | H Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aim 2: Number of Participants Scoring >3 | Number of participants scoring >3. Patient satisfaction will be determined through a score on the Client Satisfaction Questionnaire Version 8 (Attkinson & Greenfield), where participants respond to 8 items on a 4-point scale (1=very dissatisfied; 4=very satisfied). Results reported indicate clients with a patient satisfaction score over 80%. | End of Treatment at 8 Weeks | |
Primary | Aim 2: Rate of Recruitment of Eligible Participants | Rate of recruitment was measured by calculating the average of eligible participants who were recruited per week | 20 weeks | |
Primary | Aim 2: Participant Retention | Percentage of participants retained through follow-up | End of study at Week 16 Follow-up | |
Primary | Aim 2: Percentage of Participants That Completed Questionnaires | Percentage of participants who completed questionnaires at week 16 | End of study at Week 16 Follow-up | |
Secondary | Aim 3: Percent of Smoking Abstinence End of Treatment | Participants will self-report of no smoking in the last 7 days using the 7-day point prevalence. | End of Treatment at 8 Weeks | |
Secondary | Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up | Percent of smoking abstinence, measured by biochemical verification of abstinence via saliva continine and self-report of no smoking in the past 7 days. Participants who report abstinence will be mailed a saliva continine kit to confirm abstinence at their 16 week follow up call. | At 16 week follow-up | |
Secondary | Aim 3: Percent of Heavy Alcohol Use at End of Treatment | Percent of heavy drinking days during the prior week. Heavy drinking is defined as greater or equal to 4 drinks per day for women and greater or equal to 5 drinks per day for men. | End of Treatment at 8 Weeks | |
Secondary | Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up | Percent of heavy drinking days during the prior week. Heavy drinking is defined as greater or equal to 4 drinks per day for women and greater or equal to 5 drinks per day for men. | At 16 week follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
Recruiting |
NCT06033599 -
Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement
|
Phase 3 | |
Enrolling by invitation |
NCT05415371 -
Persistent Poverty Counties Pregnant Women With Medicaid
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Completed |
NCT06105424 -
BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability
|
N/A | |
Completed |
NCT01311830 -
Enhancing Smoker Utilization of the Minnesota Quitline Through Support Persons
|
N/A | |
Completed |
NCT04566198 -
Smoking in the Paris Fire Brigade and Comparison According to the Type of Service (Permanent or On-call)
|
||
Completed |
NCT04107779 -
Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS
|
N/A | |
Completed |
NCT05092919 -
The Effect of Sweet Flavoring on the Rewarding and Reinforcing Value of Cigarillo Use Among Young Adults
|
Early Phase 1 | |
Terminated |
NCT05274217 -
Journey of Transformation Curriculum for Native American Adolescents
|
N/A | |
Enrolling by invitation |
NCT06042361 -
Enhancing Equity in Smoke-free Housing
|
N/A | |
Completed |
NCT03235713 -
EMA for Tobacco Control Policy Research
|
||
Withdrawn |
NCT03352635 -
Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Clinical and Biomarkers Core
|
N/A | |
Completed |
NCT03151421 -
Air Quality Feedback to Reduce Second-hand Smoke (SHS) Exposure in the Home
|
N/A | |
Completed |
NCT03446170 -
Effect of Cigarette Pack Warnings and Packaging Among Young Adult Smokers
|
N/A | |
Completed |
NCT04104152 -
CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting
|
N/A | |
Not yet recruiting |
NCT05999383 -
Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration
|
Phase 2 | |
Recruiting |
NCT04429568 -
THC Crossover Study
|
N/A | |
Completed |
NCT04632030 -
Shrinking the Size of the Tobacco Power Wall
|
N/A | |
Completed |
NCT04143256 -
Evaluating Selected Constituents in the Exhaled Breath Samples
|
N/A |