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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00237003
Other study ID # NIAAASTE14495
Secondary ID R01AA014495NIAAA
Status Completed
Phase Phase 3
First received October 11, 2005
Last updated May 10, 2010
Start date September 2003
Est. completion date August 2009

Study information

Verified date May 2010
Source Butler Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the efficacy of a brief motivational intervention for alcohol use in incarcerated women.


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.


Recruitment information / eligibility

Status Completed
Enrollment 326
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- incarcerated women

- current hazardous drinking

- current HIV risk behavior

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
motivational interviewing
Assessment plus motivational interview condition -- two motivational interview sessions are conducted during the first month of this six month study participation.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Butler Hospital National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Outcome

Type Measure Description Time frame Safety issue
Primary alcohol use 6 months No
Primary HIV risk taking 6 months No
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