Contingency Management for Patients With Alcohol-Associated Liver Disease Following Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Non-Drinking Days
研究概览
简要总结
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 U.S. 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 or by phone. 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 subject's 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 and/or 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.
详细描述
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).
Subjects will be recruited directly by research staff as well through MyChart messages.
For in-clinic subjects: Subjects will be identified by the RA via EMR review of patients listed for the day's clinic. 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. They will ask patients if the RA may contact them via phone to explain the study in more detail and/or answer any questions the subject may have after reviewing the flyer. If the subject agrees to be contacted, the Co-investigator will notify the RA and let the RA know that the subject has provided consent to contact. The RA will only contact the subject if the Co-Investigator has indicated the subject has provided permission to contact him or her. If the subject has declined permission for contact, the RA will not contact the subject, either by phone or other communication.
Alternatively, the RA may also approach potential subjects identified in clinic. The RA will provide the study flyer, explain the study in detail, and answer any questions the subject may have. If the subject voices interest in participating in the study, the RA can schedule the Consent and Baseline Visit that is mutually agreeable for the subject and RA. The RA will provide study contact information to the subject in case he or she needs to reschedule, or if any issues arise.
Identification by Clinical Staff: The PI will send quarterly emails to the clinical staff of the post-liver transplant clinics which includes physicians, nurse practitioners, social workers, and staff nurses. The email includes a brief summary of the study and the Eligibility Criteria. If the clinical staff have identified any potential subjects, they will email the PI or research assistant who will review the subject's electronic medical record to confirm eligibility. Once screened, the RA will send a MyChart message to the potential subject with study details and study contact information. If the subject is interested in the study and responds to the MyChart message through MyChart, by email, or by phone, then the RA will schedule the Consent and Baseline Visit according to the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects 18 years of age or older
- •Have received a liver transplant
- •Has documented return to drinking (subjective or objective) within the past 60 days
- •Willing to partake in behavioral treatment for AUD
- •Written informed consent and ability for subject to comply with the requirements of the study.
排除标准
- •Current treatment for another substance use disorder
- •Unwilling to partake in behavioral treatment for AUD
- •Unwilling to provide written informed consent
- •Non-English speaking
研究组 & 干预措施
Contingency Management (CM)
Study subjects who have received a liver transplant and have been randomized to the treatment arm will receive contingency management, a positive reinforcement behavioral treatment with escalating rewards for consecutive either negative urine and blood tests (or lower value of metabolites than the previous week for PeTH) depending on which results are received first, capped at a maximum of $80 (in the form of a gift card) at the week 10 visit.
干预措施: Contingency Management (Behavioral)
Treatment As Usual (TAU)
Study Subjects randomized to treatment as usual (TAU) will not receive an intervention. They will continue with follow-up visits in the outpatient clinic as part of standard of care. .
结局指标
主要结局
Number of Non-Drinking Days
时间窗: 10 Weeks
The primary outcome for the study is the number of non-drinking days, which will be assessed by objective measures (i.e., presence of alcohol biomarkers in the blood and urine), as well as subjective measures (i.e., Timeline Followback). For the 10-week CM intervention, there will be a maximum of 70 non-drinking days.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS® 29+2 Profile v2.1 (PROPr))(10 Weeks)
- Client Satisfaction Questionnaire-8.(10 Weeks)
研究者
Arpan A. Patel, MD
Hepatologist, Assistant Professor, David Geffen School of Medicine at UCLA
University of California, Los Angeles
