Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534905
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
E-cigarette Switching Older Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Randomized Controlled Trial of E-cigarette Switching Among Older Adults with Opioid Use Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if adults 50 years and older who currently smoke tobacco and are in treatment for opioid use disorder will switch to using e-cigarettes instead of continued smoking Participants will not have a plan to quit smoking and will not be actively trying to quit smoking at the start of the trial The main questions the study aims to answer are
Are e-cigarettes a feasible and acceptable harm-reduction tool among older adults who currently smoke tobacco and don39t have a plan to quit
Will switching to e-cigarettes and reducing tobacco use be more likely among patients given access to e-cigarettes compared to individuals who are exposed to a standard brief intervention for smoking cessation control
Does the accuracy of nicotinetobacco knowledge change after participants are exposed to education on the harms of nicotine relative to no education
Participants will complete a baseline session BL and follow-up visits at weeks 2 6 and 8 each lasting 30-90 minutes for a total of approximately 3-4 hours of participation in the study Each session will include computerized assessments of tobacco and other substance use health status mood and functioning
Patients will be randomly assigned at baseline if meeting eligibility criteria to receive an e-cigarette product name of product NJOY Ace or brief advice to quit smoking in alignment with recommendations by the American Society of Addiction Medicine
Are e-cigarettes a feasible and acceptable harm-reduction tool among older adults who currently smoke tobacco and don39t have a plan to quit
Will switching to e-cigarettes and reducing tobacco use be more likely among patients given access to e-cigarettes compared to individuals who are exposed to a standard brief intervention for smoking cessation control
Does the accuracy of nicotinetobacco knowledge change after participants are exposed to education on the harms of nicotine relative to no education
Participants will complete a baseline session BL and follow-up visits at weeks 2 6 and 8 each lasting 30-90 minutes for a total of approximately 3-4 hours of participation in the study Each session will include computerized assessments of tobacco and other substance use health status mood and functioning
Patients will be randomly assigned at baseline if meeting eligibility criteria to receive an e-cigarette product name of product NJOY Ace or brief advice to quit smoking in alignment with recommendations by the American Society of Addiction Medicine
Detailed Description:
Volunteers will be patients diagnosed with opioid use disorder OUD who have been in medication-based treatment methadone or buprenorphine at the University of Maryland Addiction Treatment Center UMATC at 1001 W Pratt Street for at least 3 months The 3-month requirement will help to ensure that patients who enroll in this study have been stabilized on methadone and buprenorphine which are first-line evidence-based treatments for OUD
All procedures associated with this study will be conducted at the UMATC After completion of brief pre-screen questions to determine eligibility ie age tobacco use status and plans to quit smoking patients will complete a baseline session BL and follow-up visits at weeks 2 6 and 8 lasting between 30-90 minutes each with a total time of participation in the study of approximately 3-4 hours Each session will include computerized assessments of tobacco and other substance use health status mood and functioning In addition patients will be asked to provide a sample of their breath by breathing into a handheld device that measures air breath carbon monoxide levels
At baseline participants will be randomly assigned using a number generator to one of two conditions during the baseline session
1 standard brief advice for motivating patients to quit including linkage to a smoking cessation phone quitline or 2 education on tobacco harms and provisions of NJOY Ace e-cigarette menthol or tobacco flavor depending on patient preference NJOY Ace e-cigarettes are a consumer product that has been authorized by the United States Food and Drug Administration Participants will also be given disposable pods prefilled with nicotine When the pod is empty the participant will throw it away and replace it with a new pod provided by the study staff Participants will be asked to use as little or as much of the e-cigarette during their study participation including choosing not to use the product
All procedures associated with this study will be conducted at the UMATC After completion of brief pre-screen questions to determine eligibility ie age tobacco use status and plans to quit smoking patients will complete a baseline session BL and follow-up visits at weeks 2 6 and 8 lasting between 30-90 minutes each with a total time of participation in the study of approximately 3-4 hours Each session will include computerized assessments of tobacco and other substance use health status mood and functioning In addition patients will be asked to provide a sample of their breath by breathing into a handheld device that measures air breath carbon monoxide levels
At baseline participants will be randomly assigned using a number generator to one of two conditions during the baseline session
1 standard brief advice for motivating patients to quit including linkage to a smoking cessation phone quitline or 2 education on tobacco harms and provisions of NJOY Ace e-cigarette menthol or tobacco flavor depending on patient preference NJOY Ace e-cigarettes are a consumer product that has been authorized by the United States Food and Drug Administration Participants will also be given disposable pods prefilled with nicotine When the pod is empty the participant will throw it away and replace it with a new pod provided by the study staff Participants will be asked to use as little or as much of the e-cigarette during their study participation including choosing not to use the product
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None