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Completed

NCT Number: NCT03481049

Individualizing Incentives for Alcohol in the Severely Mentally Ill

The investigators will evaluate the efficacy of a 2 various contingency management (CM) interventions (High-Magnitude CM, Shaping CM) for treating heavy drinking among individuals with serious mental illness and alcohol dependence who are seen within the context of a community mental health center setting. Participants will be 400 adults diagnosed with serious mental illness and alcohol dependence and those who demonstrate heavy drinking during the first 4 weeks will be randomized to receive treatment conditions.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sound Health, Seattle, Washington, United States

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About this study

The objective of this study is to determine whether modifications to a CM intervention improve outcomes and reduce costs in heavy drinkers with serious mental illness using alcohol biomarker ethyl glucuronide (EtG) to test of alcohol abstinence. In CM, patients receive tangible rewards for demonstrating drug abstinence.

The investigators propose to examine whether 2 strategies - 1. Increasing reinforcer magnitude (High-Magnitude CM) or 2. Reinforcing light drinking before reinforcing abstinence (Shaping CM) - can improve outcomes in heavy drinkers with serious mental illness. The investigators will compare the efficacy of these 2 approaches to Usual CM in heavy drinkers with serious mental illness.

A total of 400 participants receiving treatment as usual at 2 treatment agencies will take part in a 4-week induction period. Participants (n=240) who attain a mean EtG > 349 ng/mL (heavy drinking) during the induction period will be randomized to either a) 4 months of standard-magnitude CM for submitting alcohol-abstinent EtG samples (EtG < 150 ng/mL) (Usual CM), b) 4 months of high-magnitude CM for submitting alcohol-abstinent EtG samples (High-Magnitude CM), or c) 1 month of CM for submitting alcohol samples that indicate light drinking (EtG < 500 ng/mL), followed by 3 months of CM for submitting alcohol-abstinent EtG samples (Shaping CM). The primary outcome will be EtG-verified alcohol abstinence during the last 3 months of treatment (when all reinforcement is contingent on abstinence) and during 12 months of follow-up.

The investigators will also examine group differences in secondary outcomes, conduct a comprehensive economic analysis, and determine whether variables that make up the NIAAA Addictions Neuroclinical Assessment (ANA) model moderate alcohol abstinence.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 to 65 years.
  • 4 or more standard drinks for females (AFAB)/ 5 or more standard drinks for males (AMAB) on 5 or more occasions in the past 30 days.
  • DSM-5 diagnosis of moderate to severe alcohol use disorder.
  • DSM-5 diagnosis of schizophrenia or schizoaffective disorder, bipolar I or II, or recurrent major depressive disorder (>1 episode).

Exclusion criteria

  • Current DSM-5 diagnosis of a severe substance use disorder for any substances used within the past 30 days
  • A significant risk of medically dangerous alcohol withdrawal (e.g. a history of seizures in the last 12 months, participant or clinician concern that abstinence will induce dangerous alcohol withdrawal).
  • Any medical/psychiatric condition, or severity of that condition, that in the opinion of the PI, would compromise safe study participation.
  • Inability to provide informed consent as measured by the MacCAT-CR. (e.g. dementia)
  • Pregnant or planning to become pregnant.

Treatment and study plan

Usual CM

Behavioral

Behavioral reinforcement for alcohol abstinence

High-Magnitude CM

Behavioral

Behavioral reinforcement for alcohol abstinence

Shaping CM

Behavioral

Behavioral reinforcement for alcohol abstinence

Primary outcomes

  1. Alcohol Use Assessed by Ethyl Glucuronide (EtG) Detection in Urine

    Time frame: During weeks 5 -16 of treatment

    Proportion of uEtG negative samples during weeks 5-16 of treatment. (EtG <150 ng/mL = EtG-negative)

Secondary outcomes

  1. Positive and Negative Syndrome Scale

    Time frame: At baseline, week 4, 8, 12, 16 through study completion

    Psychiatric symptomology

  2. Urinanalysis for Drug Use

    Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)

    Urine tests for drug use

  3. Addiction Severity Index (ASI)

    Time frame: Baseline, week 4, 8, 12, 16 through study completion

    Alcohol and drug addiction severity

  4. Alcohol and Cigarette Timeline Followback

    Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)

    Alcohol and Cigarette Use

  5. Fagerstrom Test of Nicotine Dependence

    Time frame: Baseline, week 4, 8, 12, 16 through study completion

    Presence and severity of nicotine dependence

  6. Housing Timeline FollowBack

    Time frame: Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion

    Assess homelessness

  7. Brief HIV Risk Behavior Scale

    Time frame: Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion

    HIV risk behavior; with a "drug use" subscale measuring 0 - 30 (with lower scores representing better health outcomes related to drug use and higher scores representing poorer health outcomes related to drug use) and a "sexual behavior" subscale measuring 0 - 25 (with lower scores representing better health outcomes related to sexual behavior and higher scores representing poorer health outcomes related to sexual behavior). Both are summed to create a total score ranging from 0 - 55 (with lower totals representing better health outcomes related to HIV risk and higher totals representing poorer health outcomes related to HIV risk)

  8. NIH Toolbox Emotion Battery

    Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion

    Negative emotionality

  9. NIH Toolbox Cognition Battery

    Time frame: Baseline, weeks 20, 47, 71

    Executive functioning

  10. Obsessive-Compulsive Drinking Scale

    Time frame: Baseline, 16 weeks of treatment (repeated measure) through study completion

    Self-report measure of frequency and consequences alcohol-related thoughts and behaviors; Obsessive subscale ranges from 0 - 20 (with lower score representing better health outcomes and higher scores representing poorer health outcomes) Compulsive subscale ranges from 0 -20 (with lower scores representing better health outcomes and higher scores representing poorer health outcomes). Total score (Obsessive + Compulsive sub scales ) ranging from 0 - 40 (with lower totals representing better health outcomes and higher totals representing poorer health outcomes).

  11. Stimulus-Response Compatibility Task

    Time frame: Baseline, weeks 20, 47, 71

    Cognitive measure of approach-avoidance of alcohol-related cues

  12. Stages of Change Readiness and Treatment Eagerness Scale

    Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion

    Motivation to change alcohol use; total scores range from 19 - 95 (with lower totals representing lesser readiness/eagerness for change and higher totals representing greater readiness/eagerness to change)

  13. Treatment Experiences and Expediencies Questionnaire

    Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion

    Assess drinking goals

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Novel EtG-Based Contingency Management for Alcohol in the Severely Mentally Ill

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2018
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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