Trial Outcomes & Findings for Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder (NCT NCT04094584)

NCT ID: NCT04094584

Last Updated: 2023-06-22

Results Overview

Percentage of enrolled participants who attend final study visit at the end of the intervention period

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 179 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2023-06-22

Participant Flow

Participant milestones

Measure	Multimodal Intervention The intervention is multimodal and consists of: 1. Intramuscular injections of 380mg extended-release Naltrexone, given once monthly for 3 months. 2. Case Management services Extended Release Naltrexone: Monthly Injections of 380mg Extended-Release Naltrexone, case management services as needed tailored to the individual participant
Overall Study STARTED	179
Overall Study Screened for Eligibility	55
Overall Study Enrolled and Received First Injection	32
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	156

Reasons for withdrawal

Measure	Multimodal Intervention The intervention is multimodal and consists of: 1. Intramuscular injections of 380mg extended-release Naltrexone, given once monthly for 3 months. 2. Case Management services Extended Release Naltrexone: Monthly Injections of 380mg Extended-Release Naltrexone, case management services as needed tailored to the individual participant
Overall Study No interest in study	88
Overall Study Unwilling to undergo screening tests	36
Overall Study Liver disease (enzymes >5 times upper limit of cirrhosis)	8
Overall Study Opioid use	7
Overall Study Need for major surgery in study period	4
Overall Study eligible but declined enrollment	4
Overall Study Chose to stop injections after week 4 but continued case management and provided complete data	2
Overall Study Missed study visits resulting. in incomplete data but sufficient for a pre-post comparison	2
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder

Baseline characteristics by cohort

Measure	Multimodal Intervention n=32 Participants The intervention is multimodal and consists of: 1. Intramuscular injections of 380mg extended-release Naltrexone, given once monthly for 3 months. 2. Case Management services Extended Release Naltrexone: Monthly Injections of 380mg Extended-Release Naltrexone, case management services as needed tailored to the individual participant
Age, Continuous	43 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Race/Ethnicity, Customized Demographic characteristics: · White	23 Participants n=5 Participants
Race/Ethnicity, Customized Demographic characteristics: · Asian or Pacific Islander	2 Participants n=5 Participants
Race/Ethnicity, Customized Demographic characteristics: · Native American	1 Participants n=5 Participants
Race/Ethnicity, Customized Demographic characteristics: · LatinX	6 Participants n=5 Participants
Annual income	30,000 U.S. Dollars/ year n=5 Participants
Education	14 years n=5 Participants
Employed	21 Participants n=5 Participants
Stable housing	21 Participants n=5 Participants
Comorbid serious mental illness	8 Participants n=5 Participants
Tobacco use	20 Participants n=5 Participants
Any comorbid substance use	16 Participants n=5 Participants
Amphetamines	7 Participants n=5 Participants
Cocaine	2 Participants n=5 Participants
Cannabis	12 Participants n=5 Participants
Alcohol Use Disorder Identification Test (AUDIT) score	11 units on a scale n=5 Participants
Daily alcohol consumption over the past 14 days	7.6 drinks per day n=5 Participants
WHO drinking risk level	4 units on a scale n=5 Participants
Short Inventory of Problems Score (SIP-2R)	26 units on a scale n=5 Participants
Kemp Quality of Life Scale Score	3.6 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Percentage of enrolled participants who attend final study visit at the end of the intervention period

Outcome measures

Measure	Multimodal Intervention n=32 Participants The intervention is multimodal and consists of: 1. Intramuscular injections of 380mg extended-release Naltrexone, given once monthly for 3 months. 2. Case Management services Vivitrol (Extended Release Naltrexone): Monthly Injections of 380mg Extended-Release Naltrexone, case management services as needed tailored to the individual participant
Participants Retained in Study at 3 Months	27 Participants

PRIMARY outcome

Timeframe: 12 months

Population: These data were not collected due to COVID-19 pandemic disruptions.

Percentage of enrolled participants who complete final study visit at the end of the follow up periods

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 3 months after enrollment

Self-reported total daily alcohol consumption at 3 months, compared to baseline

Outcome measures

Measure	Multimodal Intervention n=27 Participants The intervention is multimodal and consists of: 1. Intramuscular injections of 380mg extended-release Naltrexone, given once monthly for 3 months. 2. Case Management services Vivitrol (Extended Release Naltrexone): Monthly Injections of 380mg Extended-Release Naltrexone, case management services as needed tailored to the individual participant
Change in Daily Total Alcohol Consumption From Baseline at 3 Months	-7.5 drinks per day Interval -8.6 to -5.9

PRIMARY outcome

Timeframe: 12 months after enrollment

Population: These data were not collected due to COVID-19 pandemic disruptions.

Change in self-reported total daily alcohol consumption from baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months after enrollment

Kemp Quality of Life score at 3 months compared to baseline. Score is 1-7 with higher scores indicating higher quality of life.

Outcome measures

Measure	Multimodal Intervention n=27 Participants The intervention is multimodal and consists of: 1. Intramuscular injections of 380mg extended-release Naltrexone, given once monthly for 3 months. 2. Case Management services Vivitrol (Extended Release Naltrexone): Monthly Injections of 380mg Extended-Release Naltrexone, case management services as needed tailored to the individual participant
Change in Quality of Life Score at 3 Months	1.2 score on a scale Interval 0.5 to 1.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

percentage of participants self-reporting engagement in community substance use treatment programs

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Percentage of those approached who enroll in the study

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Percentage of enrolled who self reported continuing treatment with naltrexone through their primary physician after the end of the study intervention period

Outcome measures

Measure	Multimodal Intervention n=32 Participants The intervention is multimodal and consists of: 1. Intramuscular injections of 380mg extended-release Naltrexone, given once monthly for 3 months. 2. Case Management services Vivitrol (Extended Release Naltrexone): Monthly Injections of 380mg Extended-Release Naltrexone, case management services as needed tailored to the individual participant
Continued Naltrexone Use After Intervention Period	22 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months before and after enrollment

Change in the number of emergency department visits determined by electronic medical record review

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months after enrollment

Change in World Health Organization drinking risk level from baseline. Risk levels are scored 1-4 with higher scores indicating more severe health risk from alcohol use

Outcome measures

Measure	Multimodal Intervention n=27 Participants The intervention is multimodal and consists of: 1. Intramuscular injections of 380mg extended-release Naltrexone, given once monthly for 3 months. 2. Case Management services Vivitrol (Extended Release Naltrexone): Monthly Injections of 380mg Extended-Release Naltrexone, case management services as needed tailored to the individual participant
Change in WHO Drinking Risk Level	-2 score on a scale Interval -3.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months after enrollment

Change in life consequences due to alcohol use from baseline as measured by revised short inventory of problems (score 0-45 with higher scores indicating more severe alcohol related life consequences)

Outcome measures

Measure	Multimodal Intervention n=27 Participants The intervention is multimodal and consists of: 1. Intramuscular injections of 380mg extended-release Naltrexone, given once monthly for 3 months. 2. Case Management services Vivitrol (Extended Release Naltrexone): Monthly Injections of 380mg Extended-Release Naltrexone, case management services as needed tailored to the individual participant
Change in Alcohol Related Life Consequences (Short Inventory of Problems Scale, Version 2R: SIP-2R)	-13 score on a scale Interval -19.0 to -7.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Percentage of participants receiving all 3 scheduled naltrexone injections received

Outcome measures

Measure	Multimodal Intervention n=32 Participants The intervention is multimodal and consists of: 1. Intramuscular injections of 380mg extended-release Naltrexone, given once monthly for 3 months. 2. Case Management services Vivitrol (Extended Release Naltrexone): Monthly Injections of 380mg Extended-Release Naltrexone, case management services as needed tailored to the individual participant
Receipt of All Study Naltrexone Injections	23 Participants

Adverse Events

Multimodal Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ralph Wang

University of California, San Francisco

Phone: (415) 353-4890

Email: ralph.wang@ucsf.edu

Results disclosure agreements

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