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Take part in an Alcohol Treatment study

  • Gender Both
  • Age from 18 up to and including 99

Take part in an Alcohol Treatment study


What is the purpose of the study? 

The purpose of this study is to evaluate a new digital cognitive behavioral therapy (CBT) program combining behavioral therapy with medication for adults who need or want to reduce their alcohol consumption with alcohol use disorder. The newly developed treatment program includes one-on-one counseling, medication, and an app that is designed to help people reduce or stop their alcohol consumption. We want to evaluate people’s use of the program, changes in their alcohol use, and how well the treatment is followed.

 

Who can take part? 

You might be eligible for this study if:

  • aged 18 or older;
  • Moderate or severe Alcohol Use Disorder;
  • using Apple iPhone (5th generation or higher) or Android phone (version 18 or higher);
  • currently have health insurance;
  • US resident;
  • willing to take naltrexone;
  • currently employed.

 

You will join a large number of other patients with Alcohol Use Disorder who are taking part in the study.

 

You will receive:

    • You will have completed the study when you have successfully completed all questionnaires and the monthly alcohol use diary up to 52 weeks.
    • Payments will be in the form of online gift cards with a total possible value of $455.

 

How to apply

If you would like to learn more about the study and whether you may be able to take part, please register on this website and answer the questions below. If you are eligible, you will be contacted to answer any questions you have and to schedule an appointment for you.

 

What happens if you decide to participate?

 

  • If you decide to participate, and you are eligible, you will be invited to sign an online consent form;
  • You will complete questionnaires about your background, your personal history and alcohol use history and habits (30 minutes or less);
  • The research staff will contact you months 1-6, week 32, and week 52 to complete a medication count of your medication; (10 minutes per call)
  • If you decide to participate in the study, you will be randomly assigned (randomized) to either receive:
    • the newly developed digital program, which combines behavioral therapy with medication, or
    • medication with monthly medication management visits to monitor your experience and progress
  • All treatment, regardless of what group you are assigned to, is available digitally. There will be no in-person requirements for either group.
  • If you are assigned to receive the digital program, you will need to download and interact with the mobile application which will deliver daily messages, in-app CBT content, access to a licensed drug and alcohol counselor with whom you will meet with weekly for 45 minute sessions during the first three months, and at a mutually agreed upon frequency during months 4 through 6, ranging from weekly to biweekly or monthly, depending upon your needs and preferences;
  • If you are assigned to receive medical management, there will be a 6-month course of treatment
  • At 0, 4-, 8-, 12-, 24-, 36- and 52-weeks, you will be asked about your daily alcohol use patterns, and complete approximately 8 brief surveys measuring a variety of psychological and well-being measures. (15 to 30 minutes).
  • All questionnaires and the one-on-one interview, (15 to 30 minutes), will be completed online; there is no in-person contact.
  • The one-on-one interview will be conducted after you complete the 6-month treatment phase of the study. This interview will be video and/or audio recorded.

 

Participation will last 1 year and will include a baseline visit of 30-60 minutes; monthly collection of alcohol use data, as well as research surveys at 12-, 24-, 36- and 52-weeks.

 

By taking part in this research, you also agree to:

  • provide a release of information to allow us to coordinate care with your medical care provider if you are currently in treatment for a medical or psychiatric condition; and
  • you agree to allow video/audio recording of your counseling sessions for the purposes of monitoring fidelity of the intervention. Recordings will be viewed only by the study staff. If you do not want to be recorded, you cannot take part in this study. Recordings will be destroyed within 2 years after the study is complete. Your counseling and medical management visits will only be recorded if you are randomized into the digital program arm.

Quit Genius App (QG-A)

 

  • QG-A is a smartphone application targeting alcohol use disorder, informed by the principles of CBT, Motivational Enhancement Therapy (MET), and community reinforcement (see figure 1 for screenshots).
  • QG delivers personalized, behavioral support to individuals who are seeking to change their use of alcohol.
  • QG-A includes standardized cognitive-behavioral therapy in the form of videos, in-app text, audio recordings, and quizzes, but Quit Genius can also personalize CBT exercises to particular patients based on their clinical need. The application provides users with information on how to reduce or abstain from alcohol use.

 

Apply for this trial

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  • I hereby give Link2Trials my consent to store the personal data I have provided in my personal profile and to process them for the purposes stated in the declaration of consent. View these here.

    Declaration of Consent

    April 2022

    www.link2trials.us

     

    What data do we collect?
    When you register an account, you will be asked to fill out data.

    • We will request your name, address, postcode, and town/city to contact you; for example, to make appointments or send you information.
    • In addition, we will need your phone number to contact you and send you a reminder message.
    • To create your account, we will ask for your email address. We also need this information to contact you by email; for example, to send you confirmation and reminder emails. In addition, we send emails to inform you of any new trials.
    • We need your address, postcode, and town/city in order to display local trials or studies within a certain radius.
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    These personal data are necessary for the intended and actual performance of an agreement. Without this information, we will not be able to enter into an agreement or use you as a trial subject. In addition, we will ask you for your prior consent to process of this data.

    Research purposes: “special personal data”
    In addition, certain information is requested for research purposes in order to see whether you are a match with the trial in question and to carry out the study. This information includes personal data with respect to your gender, age, medication use, fertility, height and weight, alcohol consumption, smoking habits, and other medical data and/or data concerning health.

    A large part of this information is ‘special personal data’ in the sense of the GDPR. Because this information is sensitive, we treat it with care. This data will only be processed with your explicit consent.

     



    Full privacy statement

    PRIVACY STATEMENT

    April 2022

    www.link2trials.com

     

    About us

    Link2Trials is the business that determines the means and purposes of the processing of your personal data within the meaning of the California Consumer Privacy Act (referred to hereinafter as: CCPA).

    What data do we collect and for what purposes?

    When you register an account, you will first be asked to fill in the following data:

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    After confirming your email address, we will ask you to supplement your profile with the following information:

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    • In addition, we need your telephone number in order to be able to contact you by telephone and send a reminder message. We use your address, postal code and place of residence to be able to display (local) trials or studies within a certain radius from your address.
    • Your time zone and locale are processed to display the correct time and language for you.
    • Your IP address is processed to protect your account.
    • We also need your already-stored email address to contact you by email, for example to send confirmation and reminder emails. We also send emails to alert you to new studies.

    In addition, certain special personal data are requested for research purposes, in order to assess whether you match the requirements applying to the relevant study and to subsequently conduct the study with you. The data that may be requested for research purposes include personal data relating to your gender, age, use of medication, fertility, height and weight, alcohol consumption, smoking behavior and other medical and/or health data.

    If you register for a specific study, part of the above data, including the data related to your health (special personal data), will be requested. After all, without these special data, we cannot match you with any of the available studies. The type and quantity of special personal data may vary per study, because we only collect the data necessary for that specific study.

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    We will not keep your data longer than necessary for the purpose for which they were received.

    In principle, your personal data will be retained until you cancel your account with us. When you cancel your account, the personal data will be deleted within 72 hours at the latest.

    If you have registered for a specific study and have not created an account with us, the data you have provided will be used for the application process for that specific study. Your study-specific data will be deleted within 90 days after the end of the study.

    We will ask holders of inactive accounts to reactivate their account by email. Personal data in accounts that have not been active for more than 10 years will be deleted after this period.

    The above periods apply unless there are further legal obligations for us to store the data or keep them available for longer.

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    In this context, “written” includes by email. You can email your request to us via helpdesk@link2trials.com. We will process your request as soon as possible, but always within four weeks.

    You also have the right to submit a complaint about the way in which we handle your data. You can submit any such complaints to the Federal Trade Commission.

    Changes

    We reserve the right to make changes to this privacy statement. The changes shall enter into force on the date announced for their entry into force.
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