Substance Use Disorders Clinical Trial
Official title:
Community Wise: An Innovative Multi-level Intervention to Reduce Alcohol and Illegal Drug Use
Verified date | November 2022 |
Source | University of Illinois at Urbana-Champaign |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The current project seeks to implement the Multiphase Optimization Strategy (MOST) and Community Based Participatory Research (CBPR) principles to identify the most efficient, scalable, and sustainable combination of Community Wise components. Community Wise is a manualized multi-level intervention aimed at reducing health inequalities related to alcohol and illicit drug use (AIDU).This 2x2x2x2 factorial design will be fully powered to detect change in AIDU in a sample of 528 men with substance use disorders and a history of incarceration residing in distressed communities with predominantly Black populations. Participants will be randomly assigned to one of sixteen experimental conditions.
Status | Completed |
Enrollment | 602 |
Est. completion date | January 20, 2020 |
Est. primary completion date | January 20, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Inclusion criteria for the factorial experiment participants in the study will include: - Men age 18 or older - Residence in Essex County, NJ - Willingness to be voice recorded during group sessions - Ability to speak English - Having a substance use disorder measured by the Global Appraisal of Individual Needs-Substance Problem Scale (GAIN-SPS). - Having been released from incarceration in the past 4 years. This is due to research that shows that people are more likely to be re-incarcerated within the first 4 years of release from incarceration. Exclusion Criteria: - Severe psychiatric disorders in the prior 6 months not stabilized (schizophrenia, depression with psychotic features, bipolar disorder, any psychosis), as measured by the MINI International Neuropsychiatric Interview 6 psychoticism and suicidality modules - Gross cognitive impairment as measured by the Mini Mental State Exam. - Sexual identification as female |
Country | Name | City | State |
---|---|---|---|
United States | Integrity House | Newark | New Jersey |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Urbana-Champaign | National Development and Research Institutes, Inc., National Institute on Minority Health and Health Disparities (NIMHD), North Jersey Community Research Initiative, University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Days of Alcohol or Substance Misuse in the Past 30 Days | The primary outcome was the percentage of ASM (i.e., the percentage of days each substance was used in the past month) as operationalized by the Global Assessment of Individual needs. At each time point (baseline, five follow-ups), percentage ASM was calculated by dividing the reported number of days in the past month that participants used cannabis, heroin, alcohol, opioids, or cocaine by the number of days in the month (data were collected with the Timeline Follow-Back measure), multiplied by 100. Next, mean ASM frequency per month during 5 months of follow-up was calculated by adding the percentages for each substance and dividing by 5.31 We conducted correlations for self-reported ASM in the past 30 days with toxicology urine screens to assess validity of self-reported data. | 5 months | |
Secondary | Number of People Abstinent From Alcohol and Drug Use | Number of people abstinent from alcohol and drug use, which is assessed via the timeline follow back scale | 5 months |
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