Alcohol Use Disorder Clinical Trial
Official title:
Building and Pilot Testing a Couples-based Smartphone Systems to Address Alcohol Use Disorder
This project will develop and pilot test a new smartphone-based system for AUD patients, their partners, and clinicians called PartnerCHESS. PartnerCHESS will integrate key features of ABCT and A-CHESS. PartnerCHESS will also include a Clinician Report to automatically alert clinicians of patients at risk of relapse and offer other information on how recovery is proceeding. The project has three specific aims: 1. Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve patients, partners, and clinicians. 2. Conduct a pilot test (a small randomized clinical trial) of PartnerCHESS to estimate effect size and refine the protocol, procedures, recruitment strategy, measurements, and operations for use in a large RCT. 3a. Decide whether to pursue an R01 application, and if so, 3b. plan for the R01.
Alcohol use disorder (AUD) is one of the most common substance use disorders. Yet only a small fraction of people who need treatment receive it, and most of them get only short-term support even though continuing care has been shown to be much more effective. Partner support can be critical to recovery, but many partners do not know how to support their partners' recovery or manage their own responses to it. Clinicians also lack evidence of the efforts patients are making toward recovery. Treating couples in which one member is recovering from AUD has been shown to be efficacious; in particular, Alcohol Behavioral Couples Therapy (ABCT) has shown positive outcomes. Still, ABCT has not been widely adopted, in part because of practical problems such as the stigma that goes with the partner needing to go to an addiction treatment agency to participate. A-CHESS is a smartphone-based system proven to substantially reduce relapse rates, but A-CHESS serves only the patient. This project will develop and pilot test a new smartphone-based system for AUD patients, their partners, and clinicians called PartnerCHESS. PartnerCHESS will integrate key features of ABCT and A-CHESS. PartnerCHESS will also include a Clinician Report to automatically alert clinicians of patients at risk of relapse and offer other information on how recovery is proceeding. The project has three specific aims: 1. Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve patients, partners, and clinicians. 2. Conduct a pilot test (a small randomized clinical trial) of PartnerCHESS to estimate effect size and refine the protocol, procedures, recruitment strategy, measurements, and operations for use in a large RCT. 3a. Decide whether to pursue an R01 application, and if so, 3b. plan for the R01. The project would engage 6 couples to help design PartnerCHESS, test its usability and give feedback on its utility. Once ready, the system would be tested by 34 other couples randomized to receive either PartnerCHESS + treatment as usual (TAU) or A-CHESS + TAU for a 6-month trial. The investigators will collect survey data at baseline, 2, 4, and 6 months and analyze it to see if a large clinical trial holds promise and, if so, produce an application to support a full-scale trial based on the technology developed and the research procedures employed in the pilot test. The study is important to public health because of the scope of the alcohol abuse and the potential of technology to improve the lives of both patients and partners. If successful, such technology could greatly broaden the reach and impact of AUD treatment in general and couples therapy in particular. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04788004 -
Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse
|
||
Recruiting |
NCT05684094 -
Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep to Reward- and Stress-Related Brain Function
|
N/A | |
Completed |
NCT03406039 -
Testing the Efficacy of an Online Integrated Treatment for Comorbid Alcohol Misuse and Emotional Problems
|
N/A | |
Completed |
NCT03573167 -
Mobile Phone-Based Motivational Interviewing in Kenya
|
N/A | |
Completed |
NCT04817410 -
ED Initiated Oral Naltrexone for AUD
|
Phase 1 | |
Active, not recruiting |
NCT04267692 -
Harm Reduction Talking Circles for American Indians and Alaska Natives With Alcohol Use Disorders
|
N/A | |
Completed |
NCT03872128 -
The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
|
Phase 1 | |
Completed |
NCT02989662 -
INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers
|
Phase 1/Phase 2 | |
Recruiting |
NCT06030154 -
Amplification of Positivity for Alcohol Use
|
N/A | |
Active, not recruiting |
NCT05419128 -
Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19
|
N/A | |
Completed |
NCT04564807 -
Testing an Online Insomnia Intervention
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Completed |
NCT04203966 -
Mental Health and Well-being of People Who Seek Help From Their Member of Parliament
|
||
Recruiting |
NCT05861843 -
Craving Assessment in Patients With Alcohol Use Disorder Using Virtual Reality Exposure
|
||
Terminated |
NCT04404712 -
FAAH Availability in Psychiatric Disorders: A PET Study
|
Early Phase 1 | |
Enrolling by invitation |
NCT04128761 -
Decreasing the Temporal Window in Individuals With Alcohol Use Disorder
|
N/A | |
Not yet recruiting |
NCT06163651 -
Evaluating a One-Year Version of the Parent-Child Assistance Program
|
N/A | |
Not yet recruiting |
NCT06337721 -
Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults
|
N/A | |
Not yet recruiting |
NCT06444243 -
Psilocybin-assisted Therapy for Alcohol Use Disorder
|
Phase 2 | |
Enrolling by invitation |
NCT02544581 -
Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare
|
N/A |