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A Brief Alcohol Intervention for Incarcerated Women

Primary Purpose

Alcohol Use, Incarceration

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
motivational interviewing
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use focused on measuring women, incarceration, alcohol use, motivational interviewing

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: incarcerated women current hazardous drinking current HIV risk behavior Exclusion Criteria: -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Active Comparator

    Arm Label

    1) assessment plus motivational interview

    Arm Description

    Participants are assigned, in this 6 month study, to an assessment-only condition or an assessment plus motivational interview condition. Two motivational interview sessions are conducted during the first month of study participation.

    Outcomes

    Primary Outcome Measures

    alcohol use
    HIV risk taking

    Secondary Outcome Measures

    Full Information

    First Posted
    October 11, 2005
    Last Updated
    May 10, 2010
    Sponsor
    Butler Hospital
    Collaborators
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00237003
    Brief Title
    A Brief Alcohol Intervention for Incarcerated Women
    Official Title
    A Brief Alcohol Intervention for Incarcerated Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2003 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    August 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Butler Hospital
    Collaborators
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to examine the efficacy of a brief motivational intervention for alcohol use in incarcerated women.
    Detailed Description
    Hazardous alcohol use continues to be a problem of major significance throughout the United States. Alcohol use is a prevalent condition that independently acts as an important behavioral cofactor for HIV infection in women, contributing to both sexual and drug risk. The rationale for a brief intervention with incarcerated women who hazardously use alcohol and have HIV risk behaviors is compelling. For such women, we believe that the negative effects of drinking may be increased. An intervention that successfully connects alcohol use with HIV risk behaviors may be sufficient to tip the decisional balance in favor of reducing risk-prone alcohol consumption. If alcohol consumption is reduced more generally in a person's life, this may improve judgment in pursuing behaviors which risk other negative consequences. Hazardous alcohol, and high-risk drug and sexual activities may be manifestations of a general behavior pattern among incarcerated women, and strategies that engage such individuals are needed. Given the strong association between hazardous alcohol use and high HIV risk sexual and drug activities, interventions that attempt to lower the prevalence of HIV drug and sexual risk activities by lowering alcohol consumption are well justified. Brief alcohol interventions have been efficacious in reducing alcohol use across many populations over the past decade. Comparison(s): Participants are assigned, in this 6 month study, to an assessment-only condition or an assessment plus motivational interview condition. Two motivational interview sessions are conducted during the first month of study participation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use, Incarceration
    Keywords
    women, incarceration, alcohol use, motivational interviewing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    326 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1) assessment plus motivational interview
    Arm Type
    Active Comparator
    Arm Description
    Participants are assigned, in this 6 month study, to an assessment-only condition or an assessment plus motivational interview condition. Two motivational interview sessions are conducted during the first month of study participation.
    Intervention Type
    Behavioral
    Intervention Name(s)
    motivational interviewing
    Intervention Description
    Assessment plus motivational interview condition -- two motivational interview sessions are conducted during the first month of this six month study participation.
    Primary Outcome Measure Information:
    Title
    alcohol use
    Time Frame
    6 months
    Title
    HIV risk taking
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: incarcerated women current hazardous drinking current HIV risk behavior Exclusion Criteria: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Stein, M.D.
    Organizational Affiliation
    Butler Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23786513
    Citation
    Hayaki J, Anderson BJ, Stein MD. Sexual risk-taking mediates the association between impulsivity and acquisition of sexually transmitted infections among hazardously drinking incarcerated women. Am J Addict. 2012 Nov;21 Suppl 1(Suppl 1):S63-71. doi: 10.1111/j.1521-0391.2012.00296.x.
    Results Reference
    derived
    PubMed Identifier
    22854293
    Citation
    Caviness CM, Anderson BJ, de Dios MA, Kurth M, Stein M. Prescription medication exchange patterns among methadone maintenance patients. Drug Alcohol Depend. 2013 Jan 1;127(1-3):232-8. doi: 10.1016/j.drugalcdep.2012.07.007. Epub 2012 Jul 31.
    Results Reference
    derived
    PubMed Identifier
    22458289
    Citation
    Caviness CM, Anderson BJ, Stein MD. Prevalence and predictors of sexually transmitted infections in hazardously-drinking incarcerated women. Women Health. 2012;52(2):119-34. doi: 10.1080/03630242.2011.649396.
    Results Reference
    derived
    PubMed Identifier
    21278321
    Citation
    Clarke JG, Anderson BJ, Stein MD. Hazardously drinking women leaving jail: time to first drink. J Correct Health Care. 2011 Jan;17(1):61-8. doi: 10.1177/1078345810385915.
    Results Reference
    derived
    PubMed Identifier
    20402990
    Citation
    Stein MD, Caviness CM, Anderson BJ, Hebert M, Clarke JG. A brief alcohol intervention for hazardously drinking incarcerated women. Addiction. 2010 Mar;105(3):466-75. doi: 10.1111/j.1360-0443.2009.02813.x.
    Results Reference
    derived
    PubMed Identifier
    19515290
    Citation
    Stein MD, Anderson BJ, Caviness CM, Rosengard C, Kiene S, Friedmann P, Clarke JG. Relationship of alcohol use and sexual risk taking among hazardously drinking incarcerated women: an event-level analysis. J Stud Alcohol Drugs. 2009 Jul;70(4):508-15. doi: 10.15288/jsad.2009.70.508.
    Results Reference
    derived

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    A Brief Alcohol Intervention for Incarcerated Women

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