Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06265506
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-01-11
Brief Title:
Virtual Incentive Treatment for Alcohol
Sponsor:
Washington State University
Organization:
Washington State University
Study Overview
Official Title:
Assessing the Clinical and Cost-Effectiveness of a Virtual PEth-based Contingency Management for Adults With AUD
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:
VITA
Brief Summary:
The overall objective of this program of research is to utilize phosphatidylethanol PEth a blood-based biomarker that can detect alcohol use for up to 28 days to deliver a feasible telehealth-based 26-week CM intervention This study will test a telehealth PEth-based CM model in a sample of adults with AUD n200 recruited via online platforms by randomizing individuals to six months of 1 an online cognitive behavioral therapy for AUD CBT4CBT and telehealth PEth-based CM CM condition or 2 CBT4CBT and reinforcers for submitting blood samples no abstinence required control condition Investigators will assess group differences in PEth-defined abstinence and regular excessive drinking PEth 200 ngmL and alcohol-related harms eg smoking drug use This study will address important gaps in CM research by assessing outcomes during a 12-month follow-up which is much longer than most previous CM studies using a conceptual model to identify predictors of post-treatment abstinence Investigators will conduct an economic analysis to place the cost of this model in the context of downstream CM-associated cost-offsets and improvements in personal and public health
Detailed Description:
The overall objective of this study is to utilize phosphatidylethanol PEth a blood-based biomarker that can detect alcohol use for up to 28 days to deliver a feasible telehealth-based 26-week CM intervention In a pilot trial we developed a telehealth-based PEth CM intervention where participants used a medical device the TASSO-M20 to self-collect blood for PEth testing under the observation of research staff over Zoom This intervention used a two-phase approach where the frequency of PEth testing and reinforcement was decreased from once a week to as infrequently as every four weeks once participants achieved a PEth level consistent with two to four weeks of abstinence 20 ngmL Seventy-one percent of CM participants achieved 4 weeks of abstinence versus 21 of the treatment as usual TAU group and 43 of CM participants achieved 24 weeks of abstinence compared to 0 of the TAU group p 005 Based on these promising results this study will test a telehealth PEth-based CM model in a sample of adults with AUD n200 recruited via online platforms by randomizing individuals to six months of 1 an online cognitive behavioral therapy for AUD CBT4CBT and telehealth PEth-based CM CM condition or 2 CBT4CBT and reinforcers for submitting blood samples no abstinence required control condition Investigators will assess group differences in PEth-defined abstinence and regular excessive drinking PEth 200 ngmL and alcohol-related harms eg smoking drug use This study will address important gaps in CM research by assessing outcomes during a 12-month follow-up which is much longer than most previous CM studies using a conceptual model to identify predictors of post-treatment abstinence The primary barrier to the dissemination of this model is the cost of PEth testing and CM reinforcers Investigators will conduct an economic analysis to place these costs in the context of downstream CM-associated cost- offsets and improvements in personal and public health If this model increases alcohol abstinence and is cost-effective it could reach millions of Americans with AUD that cannot or do not seek in-person care
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AA031013 | NIH | None | httpsreporternihgovquickSearchR01AA031013 |