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RCT of an Integrated Digital Intervention for Alcohol Use Disorder

Sponsored by Quit Genius

About this trial

Last updated 2 years ago

Study ID

QG01

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 7 months ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion 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.

No

Exclusion Criteria

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.

Locations

Location

Status

Recruiting