Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05881304
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2023-05-19
Brief Title:
Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC
Status:
RECRUITING
Status Verified Date:
2024-09
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:
SWITCHED
Brief Summary:
The goal of this study is to conduct a pilot randomized waitlist-controlled trial to assess the feasibility acceptability and preliminary effects of substituting the NIDA standardized research e-cigarette SREC for combusted cigarettes in MOUD-TUD who are not ready to quit smoking A waitlist controlled RCT using a mixed-methods sequential explanatory design will investigate the impact of SREC provision on 1 tobacco use behavior eg cigarettes per day primary outcome SREC use 2 biomarkers eg carbon monoxide anabasine 3 cigarette dependence and withdrawal and 4 short-term health effects and tolerability eg respiratory symptoms substance use In the proposed RCT N40 adults stable on MOUD with buprenorphine who report daily smoking recruited from MGH primary care practices will be randomly assigned to receive the SREC for 8 weeks either immediately iSREC or after an 8-week delay waitlist control WLC They will be followed an additional 4 weeks after SREC provision ends to 12 weeks in iSREC and 20 weeks in WLC
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None