Virtual Incentive Treatment for Alcohol

ConditionsAlcohol Use Disorder Alcohol Drinking Alcohol Abuse Alcohol Dependence

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorWashington State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Contingency Management
Behavioral
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).
Computer Based Training for Cognitive Behavioral Therapy for AUD (CBT4CBT)
Behavioral
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 analysis, coping with craving and emotions, problem solving, decision making, challenging thoughts, and assertive alcohol refusal. Interactive exercises and homework are used to encourage skills learning and practice.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Control Condition (Non-contingent Incentives + CBT4CBT)Active comparator 1 intervention

Group B: CM Condition (Contingency Management + CBT4CBT)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

Aim 1) Alcohol Abstinence & Aim 3) Predictors: PEth-Defined Alcohol Abstinence During CM (Aim 1) and Follow-Up (Aim 3)

Investigators will use PEth 16:0/18:1, detectable from 8 to 5,000+ ng/mL via HPLC/MS/MS to assess the primary outcome. Abstinence from alcohol, the primary outcome, will be defined as a week-over-week PEth 16:0/18:1 reduction in Initiation Phase and PEth 16:0/18:1 \< 20 ng/mL in Maintenance Phase. The primary Aim 3 outcome will be PEth-defined abstinence (PEth 16:0/18:1 \< 20 ng/mL) during the 12-month follow-up.

Time frame

Every study visit, up to 18 months

Aim 2) Alcohol-Related Harms: Addiction Severity Index (ASI) Lite

The ASI Lite will be used to assess the impact of alcohol use on psychiatric, legal, medical, and family functioning, as well as self-reported drug use.

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)

Depression symptoms will be assessed with the PHQ-9. Scores range from 0-27. A score of 1-4 is consistent with minimal depression, a score of 5-9 is consistent with mild depression, a score of 10-14 is consistent with moderate depression, a score of 15 to 19 is consistent with moderately severe depression, and a score of 20-27 is consistent with severe depression. Lower depression scores are treated as a better outcome.

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)

Anxiety symptoms will be assessed using the GAD-7. A score of 0-4 is consistent with minimal anxiety, 5-9 with mild anxiety, 10-14 with moderate anxiety, and 15-21 with severe anxiety. A lower anxiety score is treated as a better outcome.

Time frame

Once a month during the intervention, Follow Up, up to 18 months

Secondary outcomes

Aim 1) Alcohol Abstinence: Regular excessive drinking

Defined as PEth 16:0/18:1 \>=200 ng/mL.

Time frame

Every study visit, up to 18 months

Other outcomes

Aim 1) Alcohol Abstinence: uEtG-Defined Alcohol Abstinence

Urine samples will be tested for uEtG at each visit using uEtG dipcards with a threshold of 300 ng/mL

Time frame

Every study visit, up to 18 months

Aim 1) Alcohol Abstinence: Self-reported Alcohol Abstinence and Heavy Drinking

Assessed by the Alcohol Timeline Follow Back (TLFB)

Time frame

Every study visit, up to 18 months

Additional Implementation Data: Attrition

We will record attrition, defined as one month of no contact with the study team, and track attendance at study appointments.

Time frame

Every study visit, up to 18 months

Additional Implementation Data: CSQ-8

To assess participant satisfaction, we will administer the 8-item Client Satisfaction Questionnaire (CSQ-8) at weeks four and 26, with a mean score of \> 23 indicating overall satisfaction.

Time frame

Weeks 4 & 26