Trial Outcomes & Findings for Individualizing Incentives for Alcohol in the Severely Mentally Ill (NCT NCT03481049)

NCT ID: NCT03481049

Last Updated: 2025-08-11

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 392 participants
• Primary outcome timeframe: During weeks 5 -16 of treatment
• Results posted on: 2025-08-11

Participant Flow

Participant milestones

Measure	Usual CM Participants will earn at least 5 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	High-Magnitude CM Participants will earn at least 15 prize draws for alcohol abstinence during weeks 5-20, plus treatment as usual. High-Magnitude CM: Behavioral reinforcement for alcohol abstinence	Shaping CM Participants will earn prize draws (at least 5) 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	Not Randomized This is the group of participants who enrolled in the study but were not eligible for randomization. (Randomization criteria included an induction phase average uEtG \>349 ng/mL and attendance in the last week of induction.)
Overall Study STARTED	53	54	51	234
Overall Study COMPLETED	41	35	37	0
Overall Study NOT COMPLETED	12	19	14	234

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Individualizing Incentives for Alcohol in the Severely Mentally Ill

Baseline characteristics by cohort

Measure	Usual CM n=53 Participants 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	High-Magnitude CM n=54 Participants 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	Shaping CM n=51 Participants 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	Total n=158 Participants Total of all reporting groups
Age, Continuous	39.4 years STANDARD_DEVIATION 11.5 • n=5 Participants	42.6 years STANDARD_DEVIATION 11.7 • n=7 Participants	39.2 years STANDARD_DEVIATION 12.1 • n=5 Participants	40.4 years STANDARD_DEVIATION 11.8 • n=4 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	28 Participants n=7 Participants	28 Participants n=5 Participants	84 Participants n=4 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	26 Participants n=7 Participants	23 Participants n=5 Participants	74 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	42 Participants n=7 Participants	41 Participants n=5 Participants	128 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: During weeks 5 -16 of treatment

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

Outcome measures

Measure	Usual CM n=53 Participants Participants will earn at least 5 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	High-Magnitude CM n=54 Participants Participants will earn at least 15 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	Shaping CM n=51 Participants Participants will earn at least 5 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.
Alcohol Use Assessed by Ethyl Glucuronide (EtG) Detection in Urine	0.66 proportion uEtG negative Standard Deviation 0.25	0.65 proportion uEtG negative Standard Deviation 0.26	0.61 proportion uEtG negative Standard Deviation 0.28

SECONDARY outcome

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

Psychiatric symptomology

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Urine tests for drug use

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, week 4, 8, 12, 16 through study completion

Alcohol and drug addiction severity

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Alcohol and Cigarette Use

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, week 4, 8, 12, 16 through study completion

Presence and severity of nicotine dependence

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Assess homelessness

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Negative emotionality

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, weeks 20, 47, 71

Executive functioning

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, weeks 20, 47, 71

Cognitive measure of approach-avoidance of alcohol-related cues

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Assess drinking goals

Outcome measures

Outcome data not reported

Adverse Events

Usual CM

Serious events: 4 serious events

Other events: 30 other events

Deaths: 0 deaths

High-Magnitude CM

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

Shaping CM

Serious events: 7 serious events

Other events: 23 other events

Deaths: 0 deaths

Not Randomized

Serious events: 2 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual CM n=57 participants at risk Participants will earn at least 5 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	High-Magnitude CM n=55 participants at risk Participants will earn at least 15 prize draws for alcohol abstinence during weeks 5-20, plus treatment as usual. High-Magnitude CM: Behavioral reinforcement for alcohol abstinence	Shaping CM n=54 participants at risk Participants will earn prize draws (at least 5) for light drinking during weeks 5-8 and will then earn prize draws for abstinence during weeks 9-20, plus treatment as usual. Shaping CM: Behavioral reinforcement for alcohol abstinence	Not Randomized n=234 participants at risk Participants who enrolled in the study but were not eligible for randomization. (Eligibility for randomization included an average induction uEtG \>349 ng/mL and attendance in last week of induction.)
General disorders Inpatient Medical Treatment	5.3% 3/57 • Number of events 3 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	3.6% 2/55 • Number of events 3 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	11.1% 6/54 • Number of events 7 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	0.85% 2/234 • Number of events 2 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.
Psychiatric disorders Suicide Attempt Resulting In Hospitalization	1.8% 1/57 • Number of events 1 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	0.00% 0/55 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	1.9% 1/54 • Number of events 1 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	0.00% 0/234 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.
Nervous system disorders Alcohol Withdrawals that lead to hospitalization	0.00% 0/57 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	1.8% 1/55 • Number of events 1 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	0.00% 0/54 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	0.00% 0/234 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.

Other adverse events

Measure	Usual CM n=57 participants at risk Participants will earn at least 5 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	High-Magnitude CM n=55 participants at risk Participants will earn at least 15 prize draws for alcohol abstinence during weeks 5-20, plus treatment as usual. High-Magnitude CM: Behavioral reinforcement for alcohol abstinence	Shaping CM n=54 participants at risk Participants will earn prize draws (at least 5) for light drinking during weeks 5-8 and will then earn prize draws for abstinence during weeks 9-20, plus treatment as usual. Shaping CM: Behavioral reinforcement for alcohol abstinence	Not Randomized n=234 participants at risk Participants who enrolled in the study but were not eligible for randomization. (Eligibility for randomization included an average induction uEtG \>349 ng/mL and attendance in last week of induction.)
Psychiatric disorders Alcohol related ER Visit	1.8% 1/57 • Number of events 1 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	0.00% 0/55 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	3.7% 2/54 • Number of events 2 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	0.85% 2/234 • Number of events 2 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.
General disorders ER Visit	28.1% 16/57 • Number of events 29 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	16.4% 9/55 • Number of events 14 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	22.2% 12/54 • Number of events 17 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	9.0% 21/234 • Number of events 21 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.
Psychiatric disorders Inpatient Psychiatric Treatment	12.3% 7/57 • Number of events 11 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	1.8% 1/55 • Number of events 1 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	9.3% 5/54 • Number of events 5 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	1.3% 3/234 • Number of events 3 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.
Psychiatric disorders Inpatient Substance Abuse Treatment	3.5% 2/57 • Number of events 2 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	3.6% 2/55 • Number of events 2 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	1.9% 1/54 • Number of events 1 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	0.85% 2/234 • Number of events 2 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.
Social circumstances Jail	0.00% 0/57 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	3.6% 2/55 • Number of events 2 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	3.7% 2/54 • Number of events 2 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	0.85% 2/234 • Number of events 2 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.
Nervous system disorders SHOT Score >/= 3	3.5% 2/57 • Number of events 4 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	5.5% 3/55 • Number of events 3 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	0.00% 0/54 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	2.1% 5/234 • Number of events 6 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.
Psychiatric disorders Suicide attempt (not hospitalization)	1.8% 1/57 • Number of events 1 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	0.00% 0/55 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	0.00% 0/54 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	0.43% 1/234 • Number of events 1 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.
Psychiatric disorders Suicidal Ideation	33.3% 19/57 • Number of events 28 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	21.8% 12/55 • Number of events 17 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	18.5% 10/54 • Number of events 21 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	13.7% 32/234 • Number of events 35 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.
Injury, poisoning and procedural complications Other	1.8% 1/57 • Number of events 1 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	1.8% 1/55 • Number of events 1 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	1.9% 1/54 • Number of events 1 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.	0.00% 0/234 • Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant. The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences: Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events. AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.

Additional Information

Michael G. McDonell

Washington State University

Phone: 509-368-6967

Email: mmcdonell@wsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place