Virtual Incentive Treatment for Alcohol

Official title

Assessing the Clinical and Cost-Effectiveness of a Virtual PEth-based Contingency Management for Adults With AUD

Overview

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.

Interventions

• Behavioral Contingency Management
  Contingency Management (CM) is an intervention that uses positive reinforcement (e.g. gift cards) to reinforce a desired behavior (e.g. negative alcohol biomarker tests) on a frequent (e.g. weekly), escalating (e.g. $5/week) schedule (e.g. 26 weeks) in order to increase the occurrence of that behavior (e.g. long term alcohol abstinence or reduction in drinking).
• Behavioral Computer Based Training for Cognitive Behavioral Therapy for AUD (CBT4CBT)
  CBT4CBT is an evidence-based online intervention that teaches CBT principles and skills to help people with alcohol use disorder reduce their drinking. CBT4CBT teaches CBT principles through video, graphics, audio instruction, and interactive exercises. Modules include video-based examples to emphasize learning of behavioral, cognitive, and affective strategies, with an emphasis on learning from examples of individuals using skills in a range of situations. Skills taught include functional analy

Primary outcome measures

• Aim 1) Alcohol Abstinence & Aim 3) Predictors: PEth-Defined Alcohol Abstinence During CM (Aim 1) and Follow-Up (Aim 3) [Time frame: Every study visit, up to 18 months]
• Aim 2) Alcohol-Related Harms: Addiction Severity Index (ASI) Lite [Time frame: Once a month during the intervention, Follow Up, up to 18 months]
• Aim 2) Alcohol-Related Harms: Patient Health Questionnaire-9 (PHQ-9) [Time frame: Once a month during the intervention, Follow Up, up to 18 months]
• Aim 2) Alcohol-Related Harms: Generalized Anxiety Disorder-7 (GAD-7) [Time frame: Once a month during the intervention, Follow Up, up to 18 months]
• Aim 2) Alcohol-Related Harms: Short Form Health Survey-12 (SF-12) [Time frame: Once a month during the intervention, Follow Up, up to 18 months]
• Aim 2) Alcohol-Related Harms & Aim 4) Cost Analysis: Non-study Medical and Other Services (NMOS) form [Time frame: Once a month during the intervention, Follow Up, up to 18 months]
• Aim 2) Alcohol Related Harms: Fagerstrom [Time frame: Once a month during the intervention, Follow Up, up to 18 months]
• Aim 2) Alcohol Related Harms: Urine Drug Tests [Time frame: Every study visit, up to 18 months]
• Aim 2) Alcohol Related Harms: Perceived Stress Scale (PSS-10) [Time frame: Every study visit, up to 18 months]
• Aim 3) Predictors: Demographics [Time frame: Baseline]

Secondary outcome measures (1)

• Aim 1) Alcohol Abstinence: Regular excessive drinking [Time frame: Every study visit, up to 18 months]

Eligibility criteria

Inclusion criteria

• 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);
• Have a DSM-5 diagnosis of a current AUD as assessed by the Structured Clinical Interview for DSM-5;
• 18+ (individuals over 65 will be assessed for cognitive impairments)
• Are not receiving treatment for AUD
• Are able to complete virtual study visits via Zoom

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Washington State University — Spokane

Publications

• Jett JD, Tyutyunnyk D, Beck R, Palmer K, Ryan D, Sanchez J, Weeks DL, McPherson SM, Chaytor N, Kiluk B, Javors MA, Ginsburg BC, Murphy S, Hill-Kapturczak N, McDonell MG. A randomized controlled trial to assess whether a telehealth-based contingency management intervention reduces alcohol use for individuals with alcohol use disorder. Contemp Clin Trials. 2025 Mar;150:107807. doi: 10.1016/j.cct.202 PMID 39824379

Identifiers

NCT: NCT06265506 · 20320 · R01AA031013

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗