Alcohol Dependence, Bipolar Disorder, Major Depressive Disorder, Schizophrenia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALUsual CM
Behavioral reinforcement for alcohol abstinence
BEHAVIORALHigh-Magnitude CM
Behavioral reinforcement for alcohol abstinence
BEHAVIORALShaping CM
Behavioral reinforcement for alcohol abstinence
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Washington State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 18 to 65 years. 2. 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. 3. DSM-5 diagnosis of moderate to severe alcohol use disorder. 4. DSM-5 diagnosis of schizophrenia or schizoaffective disorder, bipolar I or II, or recurrent major depressive disorder (\>1 episode).
Exclusion criteria
1. Current DSM-5 diagnosis of a severe substance use disorder for any substances used within the past 30 days 2. 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). 3. Any medical/psychiatric condition, or severity of that condition, that in the opinion of the PI, would compromise safe study participation. 4. Inability to provide informed consent as measured by the MacCAT-CR. (e.g. dementia) 5. Pregnant or planning to become pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use Assessed by Ethyl Glucuronide (EtG) Detection in Urine | During weeks 5 -16 of treatment | Proportion of uEtG negative samples during weeks 5-16 of treatment. (EtG \<150 ng/mL = EtG-negative) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Syndrome Scale | At baseline, week 4, 8, 12, 16 through study completion | Psychiatric symptomology |
| Urinanalysis for Drug Use | Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) | Urine tests for drug use |
| Addiction Severity Index (ASI) | Baseline, week 4, 8, 12, 16 through study completion | Alcohol and drug addiction severity |
| Alcohol and Cigarette Timeline Followback | Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) | Alcohol and Cigarette Use |
| Fagerstrom Test of Nicotine Dependence | Baseline, week 4, 8, 12, 16 through study completion | Presence and severity of nicotine dependence |
| Housing Timeline FollowBack | Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion | Assess homelessness |
| Brief HIV Risk Behavior Scale | 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) |
| NIH Toolbox Emotion Battery | Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion | Negative emotionality |
| NIH Toolbox Cognition Battery | Baseline, weeks 20, 47, 71 | Executive functioning |
| Obsessive-Compulsive Drinking Scale | 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). |
| Stimulus-Response Compatibility Task | Baseline, weeks 20, 47, 71 | Cognitive measure of approach-avoidance of alcohol-related cues |
| Stages of Change Readiness and Treatment Eagerness Scale | 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) |
| Treatment Experiences and Expediencies Questionnaire | Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion | Assess drinking goals |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual CM Participants will earn at least 3 prize draws each time they submit an alcohol negative urine samples during weeks 5-20, plus treatment as usual
Usual CM: Behavioral reinforcement for alcohol abstinence | 53 |
| High-Magnitude CM Participants will earn twice as many prize draws than those in the Usual CM for alcohol abstinence during weeks 5-20, plus treatment as usual.
High-Magnitude CM: Behavioral reinforcement for alcohol abstinence | 54 |
| Shaping CM Participants will earn prize draws for light drinking during weeks 5-8 instead of alcohol abstinence and will then earn prize draws for abstinence during weeks 9-20, plus treatment as usual.
Shaping CM: Behavioral reinforcement for alcohol abstinence | 51 |
| Total | 158 |
Baseline characteristics
| Characteristic | Total | Usual CM | High-Magnitude CM | Shaping CM |
|---|---|---|---|---|
| Age, Continuous | 40.4 years STANDARD_DEVIATION 11.8 | 39.4 years STANDARD_DEVIATION 11.5 | 42.6 years STANDARD_DEVIATION 11.7 | 39.2 years STANDARD_DEVIATION 12.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 2 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 2 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 128 Participants | 45 Participants | 42 Participants | 41 Participants |
| Sex: Female, Male Female | 84 Participants | 28 Participants | 28 Participants | 28 Participants |
| Sex: Female, Male Male | 74 Participants | 25 Participants | 26 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 54 | 0 / 51 | 0 / 234 |
| other Total, other adverse events | 30 / 57 | 21 / 55 | 23 / 54 | 63 / 234 |
| serious Total, serious adverse events | 4 / 57 | 3 / 55 | 7 / 54 | 2 / 234 |
Outcome results
Primary
Alcohol Use Assessed by Ethyl Glucuronide (EtG) Detection in Urine
Proportion of uEtG negative samples during weeks 5-16 of treatment. (EtG \<150 ng/mL = EtG-negative)
Time frame: During weeks 5 -16 of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual CM | Alcohol Use Assessed by Ethyl Glucuronide (EtG) Detection in Urine | 0.66 proportion uEtG negative | Standard Deviation 0.25 |
| High-Magnitude CM | Alcohol Use Assessed by Ethyl Glucuronide (EtG) Detection in Urine | 0.65 proportion uEtG negative | Standard Deviation 0.26 |
| Shaping CM | Alcohol Use Assessed by Ethyl Glucuronide (EtG) Detection in Urine | 0.61 proportion uEtG negative | Standard Deviation 0.28 |
Secondary
Addiction Severity Index (ASI)
Alcohol and drug addiction severity
Time frame: Baseline, week 4, 8, 12, 16 through study completion
Secondary
Alcohol and Cigarette Timeline Followback
Alcohol and Cigarette Use
Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Secondary
Brief HIV Risk Behavior Scale
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)
Time frame: Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion
Secondary
Fagerstrom Test of Nicotine Dependence
Presence and severity of nicotine dependence
Time frame: Baseline, week 4, 8, 12, 16 through study completion
Secondary
Housing Timeline FollowBack
Assess homelessness
Time frame: Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion
Secondary
NIH Toolbox Cognition Battery
Executive functioning
Time frame: Baseline, weeks 20, 47, 71
Secondary
NIH Toolbox Emotion Battery
Negative emotionality
Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
Secondary
Obsessive-Compulsive Drinking Scale
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).
Time frame: Baseline, 16 weeks of treatment (repeated measure) through study completion
Secondary
Positive and Negative Syndrome Scale
Psychiatric symptomology
Time frame: At baseline, week 4, 8, 12, 16 through study completion
Secondary
Stages of Change Readiness and Treatment Eagerness Scale
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)
Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
Secondary
Stimulus-Response Compatibility Task
Cognitive measure of approach-avoidance of alcohol-related cues
Time frame: Baseline, weeks 20, 47, 71
Secondary
Treatment Experiences and Expediencies Questionnaire
Assess drinking goals
Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
Secondary
Urinanalysis for Drug Use
Urine tests for drug use
Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)