Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05918887
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2023-06-15
Brief Title:
Feasibility and Acceptability of Switching to E-cigarettes Among Cigarette Smokers Engaged in SUD Treatment
Sponsor:
University of Nevada Reno
Organization:
University of Nevada Reno
Study Overview
Official Title:
Feasibility and Acceptability of Switching to E-cigarettes Among Cigarette Smokers Engaged in Substance Use Disorder Treatment
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the proposed study is to examine the feasibility of integrating a smoking harm reduction program featuring provision of e-cigarettes and tailored instructions to switch into an existing substance use disorder treatment program This longitudinal study includes three weeks of micro-surveys delivered via text messages to evaluate the interventions feasibility and acceptability gather initial effectiveness data and understand participants lived experience of smoking and vaping while engaged in substance use disorder treatment
Detailed Description:
The purpose of this study is to examine the feasibility of integrating a smoking harm reduction program featuring provision of e-cigarettes and tailored instructions to switch into an existing substance use disorder treatment program
The proposed longitudinal study will include three weeks of micro-surveys delivered via text messages called ecological momentary assessments or EMA to evaluate the interventions feasibility and acceptability gather initial effectiveness data and understand participants lived experience of smoking and vaping while engaged in substance use disorder treatment As people gain access to substance use disorder treatment and the acute risk of death due to overdose diminishes there is a significant need for data-driven novel and scalable smoking harm reduction approaches that meet people in recovery where they are and help them live longer healthier lives by either significantly reducing their smoking frequency or switching completely to a much lower harm nicotine product
Up to 30 daily cigarette smokers who are engaged in a substance use disorder treatment program and are not interested in quitting nicotine use but are interested in reducing the harm from smoking will be enrolled in the study Aims include
Aim 1 Examine the feasibility eg enrollment attrition acceptability eg e-cigarette use rates user experience and effectiveness eg who reduced smoking by at least 50 in Week 3 vs Week 1 who switched completely at Week 3 of the intervention on cigarette smoking among people engaged in substance use disorder treatment It is anticipated that of the 30 people enrolled 20 will complete the protocol In Week 1 participants will report their usual smoking to establish baseline behavior In Week 2 participants will be provided with an e-cigarette nicotine liquid and instructions to switch developed in Aim 1 In Week 3 participants nicotine liquid supply will be replenished and data collection will continue
Aim 2 Describe participants understanding of the meaning and utility of cigarettes and e-cigarettes in their lives Up to 20 participants will take part in a semi-structured interview at the end of Week 3 Interviews will focus on their experience trying to switch while engaged in substance use disorder treatment and how their cognitions expectancies social relationships and norms evolved over the 2 weeks of e-cigarette use Qualitative data will complement quantitative data adding participants understanding of the why driving their behavior to the what captured with EMA and will identify opportunities to improve the intervention and identify blind spots in our assessments for the main study In-depth interviews also facilitate investigation of exploratory hypotheses that arise during data collection suggesting additional areas of inquiry for a subsequent R01 proposal
The proposed longitudinal study will include three weeks of micro-surveys delivered via text messages called ecological momentary assessments or EMA to evaluate the interventions feasibility and acceptability gather initial effectiveness data and understand participants lived experience of smoking and vaping while engaged in substance use disorder treatment As people gain access to substance use disorder treatment and the acute risk of death due to overdose diminishes there is a significant need for data-driven novel and scalable smoking harm reduction approaches that meet people in recovery where they are and help them live longer healthier lives by either significantly reducing their smoking frequency or switching completely to a much lower harm nicotine product
Up to 30 daily cigarette smokers who are engaged in a substance use disorder treatment program and are not interested in quitting nicotine use but are interested in reducing the harm from smoking will be enrolled in the study Aims include
Aim 1 Examine the feasibility eg enrollment attrition acceptability eg e-cigarette use rates user experience and effectiveness eg who reduced smoking by at least 50 in Week 3 vs Week 1 who switched completely at Week 3 of the intervention on cigarette smoking among people engaged in substance use disorder treatment It is anticipated that of the 30 people enrolled 20 will complete the protocol In Week 1 participants will report their usual smoking to establish baseline behavior In Week 2 participants will be provided with an e-cigarette nicotine liquid and instructions to switch developed in Aim 1 In Week 3 participants nicotine liquid supply will be replenished and data collection will continue
Aim 2 Describe participants understanding of the meaning and utility of cigarettes and e-cigarettes in their lives Up to 20 participants will take part in a semi-structured interview at the end of Week 3 Interviews will focus on their experience trying to switch while engaged in substance use disorder treatment and how their cognitions expectancies social relationships and norms evolved over the 2 weeks of e-cigarette use Qualitative data will complement quantitative data adding participants understanding of the why driving their behavior to the what captured with EMA and will identify opportunities to improve the intervention and identify blind spots in our assessments for the main study In-depth interviews also facilitate investigation of exploratory hypotheses that arise during data collection suggesting additional areas of inquiry for a subsequent R01 proposal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None