Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304467
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-02-07
Brief Title:
CM for Patients With ALD After Liver Transplant
Sponsor:
Arpan A Patel MD
Organization:
University of California Los Angeles
Study Overview
Official Title:
Contingency Management for Patients With Alcohol-Associated Liver Disease Following Liver Transplantation
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Alcohol associated liver disease ALD refers to liver injury such as cirrhosis that is caused by alcohol use It affects 2 million adults in the US and is now the leading cause of cirrhosis-related hospitalizations cirrhosis- related deaths and liver transplantation Alcohol use disorder AUD the root cause of ALD affects 15 million Americans each year While research studies have shown that behavioral therapy and medications specific for alcohol use have helped people overcome their alcohol use disorder there has not been enough information related to how successful these treatments are specifically for people with ALD This study will look at a behavioral treatment called contingency management CM that has shown to be effective with people with other substance use disorders CM is based on the principles of operant conditioning that involves offering prize-based or monetary incentives to patients with substance use disorders to reduce substance use This study will look at the efficacy and acceptability of CM in patients who received a liver transplant and have evidence of recurrent alcohol use
The proposed study is a pilot randomized controlled trial of 30 patients with ALD who received a liver transplant 15 will be randomized to receive a 10-week CM intervention while 15 will receive treatment as usual TAU or control Subjects will be asked to complete 12 study visits including Screening and Baseline Visits that will last 1 to 2 hours each depending on the visit All visits will be completed via Zoom Study staff will instruct participants on how to use Zoom if necessary During the Screening and Baseline Visits subjects will be 1 asked to provide a urine test and blood draw 2 complete the SCID-5 AUD a semi-structured interview guide for making the major DSM-5 diagnoses 3 complete the Iowa Gambling Test which looks at decision-making skills 4 complete a survey that looks at the subjects quality of life after liver transplant 4 review how much alcohol the subject has consumed in the last 30 days 5 and if the subject has received any current AUD treatments Once the Screening and Baseline visits are completed subjects will be randomized to either the CM group or the TAU group During the weekly visits subjects will be asked to provide blood and urine samples and will be asked if they have had any alcohol since their last visit All subjects will receive 20 for completing the visits For those in the CM group subjects will also receive a CM reward for negative urine andor blood tests depending on which results we receive first-with rewards ranging from 5 to 80 depending on the week Additionally during weeks 1 5 and 10 those in the CM group will also complete the Client Satisfaction Questionnaire-8 to assess client satisfaction with CM and complete a semi-structured interview about the CM protocol as well as CM acceptability and feasibility
The proposed study is a pilot randomized controlled trial of 30 patients with ALD who received a liver transplant 15 will be randomized to receive a 10-week CM intervention while 15 will receive treatment as usual TAU or control Subjects will be asked to complete 12 study visits including Screening and Baseline Visits that will last 1 to 2 hours each depending on the visit All visits will be completed via Zoom Study staff will instruct participants on how to use Zoom if necessary During the Screening and Baseline Visits subjects will be 1 asked to provide a urine test and blood draw 2 complete the SCID-5 AUD a semi-structured interview guide for making the major DSM-5 diagnoses 3 complete the Iowa Gambling Test which looks at decision-making skills 4 complete a survey that looks at the subjects quality of life after liver transplant 4 review how much alcohol the subject has consumed in the last 30 days 5 and if the subject has received any current AUD treatments Once the Screening and Baseline visits are completed subjects will be randomized to either the CM group or the TAU group During the weekly visits subjects will be asked to provide blood and urine samples and will be asked if they have had any alcohol since their last visit All subjects will receive 20 for completing the visits For those in the CM group subjects will also receive a CM reward for negative urine andor blood tests depending on which results we receive first-with rewards ranging from 5 to 80 depending on the week Additionally during weeks 1 5 and 10 those in the CM group will also complete the Client Satisfaction Questionnaire-8 to assess client satisfaction with CM and complete a semi-structured interview about the CM protocol as well as CM acceptability and feasibility
Detailed Description:
This study is a pilot randomized controlled trial of 30 patients with ALD who received a liver transplant 15 will be randomized to receive a 10-week CM intervention while 15 will receive treatment as usual control
Adult patients 18 years of age being seen in the post liver transplant outpatient clinic at UCLA will be approached to participate in the study Patients will be identified by the co-investigators in the clinic andor by research team via electronic health records EHR Once identified the Co-Investigator will approach the patient during the outpatient clinic visit with the recruitment flyer The Co-Investigator will inform the participant that they may be eligible for the study and that the RA will reach out via phone to provide more information about the study The RA will contact the potential participant via phone and ask whether they would be interested in participating in the study If so the RA will then send the participant a Zoom link so the RA can review the study requirements for study participation review the consent form and answer any questions patients may have The RA will provide instructions on how to use Zoom if necessary If the participant agrees to participate in the study the RA will send the consent form and HIPAA forms to the participant via DocuSign and the participant and RA will sign the consent form
After written consent is obtained the RA will confirm eligibility criteria
If eligibility is confirmed and signed off by the PI the participant will complete Baseline Visit activities via Zoom
1 Record socio-demographic data self-reported demographics behavior and health data and locator form
2 Complete the Iowa Gambling Task
3 Complete Structured Clinical Interview-5 for AUD SCID-5 AUD a semi-structured interview guide for making the major DSM-5 diagnoses
4 Urine sample for EtG
5 Blood draw for PeTH
6 Complete Timeline Followback TLFB a validated instrument to assess amounts of drinking within the last 30 days
7 Record concurrent AUD treatment strategies and therapies
8 Complete Patient-Reported Outcomes Measurement Information System PROMIS to assess patients quality of life after liver transplantation The psychometric properties of this instrument have been previously validated in patients who have received a liver transplant
9 Randomize participant to contingency management CM or treatment as usual TAU Participants will be randomly assigned to either the CM treatment group or the TAU group control using a SAS randomization software Participants will be stratified by applying SCID-5-AUD criteria groups will be mild or moderatesevere
All participants will receive a 20 gift card for completing this visit regardless of treatment arm
After the initial visit participants will attend weekly Zoom visits for 10 weeks and will complete assessments according to the protocol At Visit 1 Visit 5 and Visit 10 participants will also undergo audio recorded semi-structured interviews about the CM protocol as well as CM acceptability and feasibility interviews with the research team After these interviews the audio-recordings will be analyzed as part of the studys first aim to look at the acceptability and feasibility of CM in the ALD population
Since all weekly visits will be completed via Zoom participants will need to provide blood and urine samples at the nearest UCLA lab before their next weekly visit CM rewards will not be provided until the study team receives the lab results for that week
All participants will be compensated for completing each study visit with a gift card regardless of their randomization group For those in the CM group participants will also receive a CM reward for negative urine EtG andor blood tests PeTH depending on which results are received first Because PeTH can be elevated for several weeks after a positive test a lower PeTH value in a subsequent week of checking will be considered a negative result per previous studies Additionally if participants in the CM group have negative urine andor blood test for 2 consecutive weeks participants will receive a CM bonus
The primary outcome for the study is the number of non-drinking days which will be assessed by objective measures ie presence of alcohol biomarkers in the blood and urine as well as subjective measures ie Timeline Followback These assessments will be completed weekly For the 10-week CM intervention there will be a maximum of 70 non-drinking days
Secondary outcomes include
Health-related quality of life will be assessed using the Patient-Reported Outcomes Measurement Information System at the beginning and end of the intervention
Acceptability of the intervention will be assessed with the Client Satisfaction Questionnaire-8 CSQ-8 with a mean score of 24 scale 8-32 which will be considered acceptable based on prior pilot interventions for AUD and
Feasibility of the intervention will be assessed by calculating rates of recruitment and retention throughout the study period
We will also obtain qualitative descriptions of acceptability and feasibility through individual semi-structured interviews conducted with all 15 participants in the CM arm during three specific time points V1 V5 V10
Adult patients 18 years of age being seen in the post liver transplant outpatient clinic at UCLA will be approached to participate in the study Patients will be identified by the co-investigators in the clinic andor by research team via electronic health records EHR Once identified the Co-Investigator will approach the patient during the outpatient clinic visit with the recruitment flyer The Co-Investigator will inform the participant that they may be eligible for the study and that the RA will reach out via phone to provide more information about the study The RA will contact the potential participant via phone and ask whether they would be interested in participating in the study If so the RA will then send the participant a Zoom link so the RA can review the study requirements for study participation review the consent form and answer any questions patients may have The RA will provide instructions on how to use Zoom if necessary If the participant agrees to participate in the study the RA will send the consent form and HIPAA forms to the participant via DocuSign and the participant and RA will sign the consent form
After written consent is obtained the RA will confirm eligibility criteria
If eligibility is confirmed and signed off by the PI the participant will complete Baseline Visit activities via Zoom
1 Record socio-demographic data self-reported demographics behavior and health data and locator form
2 Complete the Iowa Gambling Task
3 Complete Structured Clinical Interview-5 for AUD SCID-5 AUD a semi-structured interview guide for making the major DSM-5 diagnoses
4 Urine sample for EtG
5 Blood draw for PeTH
6 Complete Timeline Followback TLFB a validated instrument to assess amounts of drinking within the last 30 days
7 Record concurrent AUD treatment strategies and therapies
8 Complete Patient-Reported Outcomes Measurement Information System PROMIS to assess patients quality of life after liver transplantation The psychometric properties of this instrument have been previously validated in patients who have received a liver transplant
9 Randomize participant to contingency management CM or treatment as usual TAU Participants will be randomly assigned to either the CM treatment group or the TAU group control using a SAS randomization software Participants will be stratified by applying SCID-5-AUD criteria groups will be mild or moderatesevere
All participants will receive a 20 gift card for completing this visit regardless of treatment arm
After the initial visit participants will attend weekly Zoom visits for 10 weeks and will complete assessments according to the protocol At Visit 1 Visit 5 and Visit 10 participants will also undergo audio recorded semi-structured interviews about the CM protocol as well as CM acceptability and feasibility interviews with the research team After these interviews the audio-recordings will be analyzed as part of the studys first aim to look at the acceptability and feasibility of CM in the ALD population
Since all weekly visits will be completed via Zoom participants will need to provide blood and urine samples at the nearest UCLA lab before their next weekly visit CM rewards will not be provided until the study team receives the lab results for that week
All participants will be compensated for completing each study visit with a gift card regardless of their randomization group For those in the CM group participants will also receive a CM reward for negative urine EtG andor blood tests PeTH depending on which results are received first Because PeTH can be elevated for several weeks after a positive test a lower PeTH value in a subsequent week of checking will be considered a negative result per previous studies Additionally if participants in the CM group have negative urine andor blood test for 2 consecutive weeks participants will receive a CM bonus
The primary outcome for the study is the number of non-drinking days which will be assessed by objective measures ie presence of alcohol biomarkers in the blood and urine as well as subjective measures ie Timeline Followback These assessments will be completed weekly For the 10-week CM intervention there will be a maximum of 70 non-drinking days
Secondary outcomes include
Health-related quality of life will be assessed using the Patient-Reported Outcomes Measurement Information System at the beginning and end of the intervention
Acceptability of the intervention will be assessed with the Client Satisfaction Questionnaire-8 CSQ-8 with a mean score of 24 scale 8-32 which will be considered acceptable based on prior pilot interventions for AUD and
Feasibility of the intervention will be assessed by calculating rates of recruitment and retention throughout the study period
We will also obtain qualitative descriptions of acceptability and feasibility through individual semi-structured interviews conducted with all 15 participants in the CM arm during three specific time points V1 V5 V10
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