COMPLETED

Integrated Digital Intervention for Alcohol Use Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a two-arm randomized clinical trial comparing the Quit Genius intervention for alcohol use disorder (QG-A) to usual care (TAU), comprising medical management of alcohol use disorders with pharmacotherapy. Participants (N=300) will be randomly assigned to either QG-A or TAU, and will be assessed at baseline, monthly throughout the 6-month intervention phase and at 3 and 6 months post-treatment, to investigate the impact of QG-A, relative to TAU on alcohol use, psychological symptoms, and health service utilization. The primary aim of the study is to evaluate the efficacy of QG-A, relative to TAU in reducing alcohol use and associated mental health and functional outcomes. A secondary aim is to examine the cost-effectiveness of QG-A, including cost savings and impact on productivity.

Official Title

Randomized Controlled Trial of an Integrated Digital Cognitive-Behavioral Therapy (CBT) and Pharmacotherapy Intervention for Adults With Alcohol Use Disorders

Quick Facts

Study Start:2023-01-01

Study Completion:2025-07-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05748639

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Aged 18 or older; * A US resident; * Using Apple iPhone (5th generation or higher) or Android phone (version 18 or higher); * Diagnostic and Statistical Manual-V diagnosis of either a moderate or severe Alcohol Use Disorder; * Currently has health insurance; * Able to provide informed consent; * Currently employed; * Willing and able to participate in study procedures; * Willing to take naltrexone; and * Good general health or, in the case of a medical/psychiatric condition needing ongoing treatment, potential participants should be under the care of a physician or other qualified healthcare provider with whom the participant provides documented permission to coordinate care with the QG-A care team.	* Known sensitivity to naltrexone; * Pregnant, breast feeding, or unwilling to use contraceptive methods; * Presence of serious medical or psychiatric disorders that would, in the opinion of the medical provider, make participation hazardous or regular follow-up unlikely (e.g., suicidal ideation, acute hepatitis, unstable cardiovascular, liver or renal disease); * A current pattern of alcohol or sedative use, as assessed by the QG-A licensed medical provider, which would preclude safe participation in the study and/or would likely require imminent medical detoxification; * Having used acamprosate, disulfiram, or naltrexone, within the past 30 days prior to screening; * Takes an opioid medication on a routine basis for a pain condition or has anticipated/planned surgery that will require opioid maintenance during the study timeframe; * Has undergone more than one inpatient medical detoxification treatment; and * Lack of proficiency in English.

Inclusion Criteria

Exclusion Criteria

* Aged 18 or older;
* A US resident;
* Using Apple iPhone (5th generation or higher) or Android phone (version 18 or higher);
* Diagnostic and Statistical Manual-V diagnosis of either a moderate or severe Alcohol Use Disorder;
* Currently has health insurance;
* Able to provide informed consent;
* Currently employed;
* Willing and able to participate in study procedures;
* Willing to take naltrexone; and
* Good general health or, in the case of a medical/psychiatric condition needing ongoing treatment, potential participants should be under the care of a physician or other qualified healthcare provider with whom the participant provides documented permission to coordinate care with the QG-A care team.

* Known sensitivity to naltrexone;
* Pregnant, breast feeding, or unwilling to use contraceptive methods;
* Presence of serious medical or psychiatric disorders that would, in the opinion of the medical provider, make participation hazardous or regular follow-up unlikely (e.g., suicidal ideation, acute hepatitis, unstable cardiovascular, liver or renal disease);
* A current pattern of alcohol or sedative use, as assessed by the QG-A licensed medical provider, which would preclude safe participation in the study and/or would likely require imminent medical detoxification;
* Having used acamprosate, disulfiram, or naltrexone, within the past 30 days prior to screening;
* Takes an opioid medication on a routine basis for a pain condition or has anticipated/planned surgery that will require opioid maintenance during the study timeframe;
* Has undergone more than one inpatient medical detoxification treatment; and
* Lack of proficiency in English.

Contacts and Locations

Study Locations (Sites)

Quit Genius

New York, New York, 10001

United States

Collaborators and Investigators

Sponsor: Quit Genius

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01

Study Completion Date2025-07-15

Study Record Updates

Study Start Date2023-01-01

Study Completion Date2025-07-15

Terms related to this study

Additional Relevant MeSH Terms

Alcohol Use Disorder