Clinical trial NCT05748639: RCT of an Integrated Digital Intervention for Alcohol Use Disorder
Official title: Randomized Controlled Trial of an Integrated Digital Cognitive-Behavioral Therapy (CBT) and Pharmacotherapy Intervention for Adults With Alcohol Use Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Alcohol Use Disorder
Lead sponsor: Quit Genius
Sponsor class: INDUSTRY
First posted: 2023-03-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is designed as a 2-arm, parallel-group, randomized controlled trial with 12-, 24-, 36-, and 52-week follow-up, to evaluate the effect of the treatment group (QG-A) versus a control group (MM) on alcohol use outcomes.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Effective and evidence-based therapies are available for management of Alcohol Use Disorder (AUD) with a variety of pharmacological and psychosocial interventions supported by a sizable clinical trials literature (7-8). However, a major barrier in addressing this significant public health issue is the fact that a majority of individuals with AUD are not receiving treatment (9). Evidence shows that Individuals with problematic alcohol use may be dissuaded from seeking help due to a lack of accessibility of services, stigmatization, low motivation, or cost of treatment (9).

Traditional methods of treating AUD typically utilize a behavioral, pharmacological or a combination approach. Medication-assisted treatment (MAT) is the use of medications, in combination with psychosocial therapies, to provide an integrated approach to the treatment of substance use disorders (7). The MAT approach to treating AUD has been widely successful, with various combinations of pharmacotherapy and psychosocial interventions showing efficacy in the reduction of alcohol use. In particular, the combination of psychosocial therapies such as CBT, MET and 12 steps have proven highly successful when used in combination with the opioid receptor antagonist Naltrexone (NTX) (7-8). Yet, a lack of accessibility, practicality and adherence to traditional methods has left many alcohol users without the means to effectively deal with their addictions (10).

Digital therapeutics can address these issues and provide advantages including anonymity, convenience, accessibility, cost-effectiveness, and privacy (11-12). Digital therapies can also target individuals with problematic alcohol use who are in different psychological stages of change, allowing potential users to investigate treatment options without the stigma associated with face-to-face interactions. Additionally, these digitized evidence-based therapies have the potential to increase treatment adherence, and because the content is standardized, it can be delivered with greater consistency than face-to-face therapy, lending itself to a clinical research approach (13).

Quit Genius Alcohol (QG-A) is a newly developed comprehensive treatment program for AUD, utilizing a combination of a mobile-app, pharmacotherapy, and breath sensor. The mobile app is informed by the principles of CBT, Motivational Enhancement Therapy (MET), and community reinforcement. QG delivers personalized, behavioral support adjunct to proven pharmacotherapies to individuals who are seeking to reduce their alcohol consumption. An initial pilot investigation of QG-A demonstrated the feasibility of the intervention as well as some promising preliminary outcomes with regards to alcohol use and related psychological variables that are recognized mechanisms of change in CBT treatment for addicted populations.

As such, the objective of the proposed investigation is to build on the preliminary outcomes and evaluate the effectiveness of QG-A. This study will compare the efficacy of QG-A, which combines CBT based counseling with pharmacotherapy for alcohol use disorders (naltrexone), delivered via an mobile health app (QG-A), relative to usual care for adults with AUD, which comprises medical management with naltrexone (MM), in reducing alcohol use and associated psychological and functional outcomes.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Alcohol use
timeFrame: Baseline to 6-months post-treatment entry
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Quit Genius
state: New York
Study officials:
References: