Clinical trial NCT06265506: Virtual Incentive Treatment for Alcohol
Official title: Assessing the Clinical and Cost-Effectiveness of a Virtual PEth-based Contingency Management for Adults With AUD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Alcohol Drinking
Alcohol Abuse
Alcohol Dependence
Keywords: Contingency Management
Alcohol Abstinence
Adult
Biological Markers
Blood
Clinical effectiveness
Cognitive Therapy
Blood collection
Ethyl glucuronide
Health Care Costs
Heavy Drinking
Addictions Neuroclinical Assessment
Cognition
Incentives
Phosphatidylethanol
Incentive salience
Anhedonia
Longitudinal Studies
Prediction of Response to Therapy
Randomized Clinical Trial
Telehealth
Virtual Health
Video conference
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center at San Antonio
name: Weill Medical College of Cornell University
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-02-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will test the efficacy of our CM model against an evidence-based online intervention, CBT4CBT, by randomizing participants to six months of:

1. CBT4CBT and reinforcement for submitting blood samples (no requirement for abstinence) (Control Condition), or
2. CBT4CBT and reinforcement for PEth tests that are consistent with alcohol abstinence (CM Condition).
Primary purpose: TREATMENT

Brief summary: The overall objective of this program of research is to utilize phosphatidylethanol (PEth), a blood-based biomarker that can detect alcohol use for up to 28 days to deliver a feasible telehealth-based 26-week CM intervention. This study will test a telehealth PEth-based CM model in a sample of adults with AUD (n=200), recruited via online platforms by randomizing individuals to six months of 1) an online cognitive behavioral therapy for AUD (CBT4CBT) and telehealth PEth-based CM (CM condition) or 2) CBT4CBT and reinforcers for submitting blood samples (no abstinence required) (control condition). Investigators will assess group differences in PEth-defined abstinence and regular excessive drinking (PEth \>= 200 ng/mL), and alcohol-related harms (e.g., smoking, drug use). This study will address important gaps in CM research by assessing outcomes during a 12-month follow-up, which is much longer than most previous CM studies; using a conceptual model to identify predictors of post-treatment abstinence. Investigators will conduct an economic analysis to place the cost of this model in the context of downstream CM-associated cost-offsets and improvements in personal and public health.

Detailed description: The overall objective of this study is to utilize phosphatidylethanol (PEth), a blood-based biomarker that can detect alcohol use for up to 28 days to deliver a feasible telehealth-based 26-week CM intervention. In a pilot trial, we developed a telehealth-based PEth CM intervention where participants used a medical device, the TASSO-M20 to self-collect blood for PEth testing under the observation of research staff over Zoom. This intervention used a two-phase approach where the frequency of PEth testing and reinforcement was decreased from once a week, to as infrequently as every four weeks once participants achieved a PEth level consistent with two to four weeks of abstinence (\< 20 ng/mL). Seventy-one percent of CM participants achieved \>4 weeks of abstinence versus 21% of the treatment as usual (TAU) group, and 43% of CM participants achieved \>24 weeks of abstinence compared to 0% of the TAU group (p \< 0.05). Based on these promising results, this study will test a telehealth PEth-based CM model in a sample of adults with AUD (n=200), recruited via online platforms by randomizing individuals to six months of 1) an online cognitive behavioral therapy for AUD (CBT4CBT) and telehealth PEth-based CM (CM condition) or 2) CBT4CBT and reinforcers for submitting blood samples (no abstinence required) (control condition). Investigators will assess group differences in PEth-defined abstinence and regular excessive drinking (PEth \>= 200 ng/mL), and alcohol-related harms (e.g., smoking, drug use). This study will address important gaps in CM research by assessing outcomes during a 12-month follow-up, which is much longer than most previous CM studies; using a conceptual model to identify predictors of post-treatment abstinence. The primary barrier to the dissemination of this model is the cost of PEth testing and CM reinforcers. Investigators will conduct an economic analysis to place these costs in the context of downstream CM-associated cost- offsets and improvements in personal and public health. If this model increases alcohol abstinence and is cost-effective it could reach millions of Americans with AUD that cannot or do not seek in-person care.

Eligibility criteria: Inclusion Criteria:

1. Had 2 heavy drinking episodes (assigned male at birth \> 4 standard drinks (SDs), assigned female at birth \> 3 SDs) or ≥14 SDs in the prior 14 days verified by PEth 16:0/18:1 biomarker \> 20 ng/mL (indicates at least 2 heavy drinking episodes in past two weeks);
2. Have a DSM-5 diagnosis of a current AUD as assessed by the Structured Clinical Interview for DSM-5;
3. 18+ (individuals over 65 will be assessed for cognitive impairments)
4. Are not receiving treatment for AUD
5. Are able to complete virtual study visits via Zoom

Exclusion Criteria:

1. have a current diagnosis of severe substance use disorder (other than AUD, tobacco, and cannabis);
2. PEth biomarker ≤ 20 ng/mL (indicates no heavy drinking in past month)
3. inability to provide informed consent based on the UBACC or MacCAT-CR;
4. alcohol withdrawal-related seizure or hospitalization in prior 12 months;
5. psychiatrically or medically unsafe to participate, as assessed by the PI; and/or
6. currently enrolled in alcohol treatment or another alcohol treatment study.

Primary outcomes:
measure: Aim 1) Alcohol Abstinence & Aim 3) Predictors: PEth-Defined Alcohol Abstinence During CM (Aim 1) and Follow-Up (Aim 3)
timeFrame: Every study visit, up to 18 months
measure: Aim 2) Alcohol-Related Harms: Addiction Severity Index (ASI) Lite
timeFrame: Once a month during the intervention, Follow Up, up to 18 months
measure: Aim 2) Alcohol-Related Harms: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Once a month during the intervention, Follow Up, up to 18 months
measure: Aim 2) Alcohol-Related Harms: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Once a month during the intervention, Follow Up, up to 18 months
measure: Aim 2) Alcohol-Related Harms: Short Form Health Survey-12 (SF-12)
timeFrame: Once a month during the intervention, Follow Up, up to 18 months
measure: Aim 2) Alcohol-Related Harms & Aim 4) Cost Analysis: Non-study Medical and Other Services (NMOS) form
timeFrame: Once a month during the intervention, Follow Up, up to 18 months
measure: Aim 2) Alcohol Related Harms: Fagerstrom
timeFrame: Once a month during the intervention, Follow Up, up to 18 months
measure: Aim 2) Alcohol Related Harms: Urine Drug Tests
timeFrame: Every study visit, up to 18 months
measure: Aim 2) Alcohol Related Harms: Perceived Stress Scale (PSS-10)
timeFrame: Every study visit, up to 18 months
measure: Aim 3) Predictors: Demographics
timeFrame: Baseline
measure: Aim 3) Predictors: Addictions Neuroclinical Assessment (ANA) Questionnaire
timeFrame: Every study visit, up to 18 months
measure: Aim 3) Predictors: TestMyBrain
timeFrame: Baseline
measure: Aim 3) Predictors: Positive Negative Affect Schedule (PANAS)
timeFrame: Every study visit, up to 18 months
measure: Aim 3) Predictors: Situational Confidence Questionnaire-8 (SCQ-8)
timeFrame: Every study visit, up to 18 months
measure: Aim 3) Predictors: Alcohol Craving VAS
timeFrame: Every study visit, up to 18 months
measure: Aim 4) Cost Analysis: Drug Abuse Treatment Cost Analysis Program (DATCAP)
timeFrame: Baseline
measure: Aim 4) Cost Analysis: PROPr
timeFrame: Once a month during the intervention, Follow Up, up to 18 months
Secondary outcomes:
measure: Aim 1) Alcohol Abstinence: Regular excessive drinking
timeFrame: Every study visit, up to 18 months
Other outcomes:
measure: Aim 1) Alcohol Abstinence: uEtG-Defined Alcohol Abstinence
timeFrame: Every study visit, up to 18 months
measure: Aim 1) Alcohol Abstinence: Self-reported Alcohol Abstinence and Heavy Drinking
timeFrame: Every study visit, up to 18 months
measure: Additional Implementation Data: Attrition
timeFrame: Every study visit, up to 18 months
measure: Additional Implementation Data: CSQ-8
timeFrame: Weeks 4 & 26
measure: Adverse Events
timeFrame: Every study visit, up to 18 months
measure: Computer Based Training for Cognitive Behavioral Health (CBT4CBT) Program Use
timeFrame: Treatment & Follow up, up to 18 months
Locations:
city: Spokane
country: United States
facility: Washington State University
state: Washington
Study officials:
affiliation: Washington State University Elson S. Floyd College of Medicine
name: Michael McDonell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Health San Antonio
name: Nathalie Hill-Kapturczak, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Cornell
name: Sean Murphy, PhD
role: PRINCIPAL_INVESTIGATOR
References: