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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00882037
Other study ID # 0335-08-FB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 12, 2008
Est. completion date December 15, 2010

Study information

Verified date September 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary goal of this study is to identify factors which may put a person that has used methamphetamine at greater risk for mental and physical health problems and social problems and factors that may lessen the risk for these problems. This study will also compare methamphetamine use between Latino and non-Latino persons and those that live in a rural area or urban area. The investigators hypothesis is that rural persons with methamphetamine dependence will have greater socio-demographic, bio-psychosocial and behavioral risk factors than their urban counterparts.


Description:

Methamphetamine (meth) is second only to alcohol as the primary drug of abuse in persons entering substance use disorders (SUD) treatment in rural Nebraska 1 . The National Survey on Drug Use and Health 2002-2005 (NSDUH) found meth use increased as the setting became more rural 2 . In a previous study comparing rural and urban persons with meth use disorders (MUD), we found significant differences, with rural persons reporting earlier first regular use of meth, greater meth-related psychotic symptoms, more alcoholism, and more intravenous (IV) use 3 . No studies have compared frequency of other behavioral risk factors in rural and urban meth users. Similarly, no studies have compared risk factors for methamphetamine dependence in this uniquely rural drug use disorder. It is critical that other high risk behaviors (in addition to IV use) be identified in rural persons with MUD and that risk factors for MUD be identified as a crucial first step in providing resources to tailor prevention efforts in rural populations. In addition to the need for further research on risk factors, scholars have called for more studies on protective factors to develop more effective intervention programs 4 . Researchers have identified factors that mitigate negative outcomes among individuals at high risk. In general, active coping and high levels of social support and empathy have been linked to better health outcomes whereas avoidance coping and low levels of social support and empathy have been associated with worse health outcomes 4, 5 . However, no factors have been identified in rural meth users which are protective for worse health outcomes. Meth distribution has been linked to "Mexican Drug Trafficking Organizations" and "Hispanic polydrug trafficking organizations" 6, 7 , but there is little research examining meth use in Latinos. In a previous study of Hispanic and non-Hispanic white individuals with MUD, Hispanics reported less education and more employment problems, 8 but the study did not address rural MUD. This proposed study of rural and urban Latinos with meth dependence will provide initial data to begin to inform prevention efforts targeting rural Latinos with MUD and may be useful in rural Latinos with other SUD. Our interdisciplinary investigative team proposes to address the following Specific Aims over a two-year period: 1) compare socio-demographic, bio-psychosocial and behavioral risk and protective factors between rural and urban persons with methamphetamine dependence (Year One); 2) identify factors that place persons with methamphetamine dependence at risk for greater psychopathology and identify factors that mitigate those persons from psychopathology (Year One); 3) compare severity of methamphetamine dependence between Latino and non-Latino populations and urban and rural Latino populations (Year Two). Our hypothesis is that rural persons with methamphetamine dependence will have greater socio-demographic, bio-psychosocial and behavioral risk factors than their urban counterparts. The targeted populations will be adults with methamphetamine dependence. We will enroll 150 individuals (75 rural and 75 urban) 75 of whom will be Latinos from substance abuse treatment sites. Data analyses will focus on comparing MUD across urban/rural and Latinos/non-Latinos. Thus, this study will identify factors which may place rural, urban, Latino, and non-Latino persons with MUD at greater risk for, or protect them from, psychopathology, infectious complications, and poorer treatment outcome. The long-term goals of this study are to: a) provide data that will strengthen a re-submission to the National Institute on Drug Abuse (Behavioral and Social Science Research on Understanding and Reducing Health Disparities, PAR-07-379 ); b) establish relationships with providers of substance abuse treatment to Latinos facilitating enrollment of Latinos in future research studies; and c) identify specific factors that can be incorporated into prevention strategies in underserved populations (e.g. Latinos, rural populations).


Recruitment information / eligibility

Status Completed
Enrollment 133
Est. completion date December 15, 2010
Est. primary completion date December 15, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults in SUD treatment facilities meeting DSM-IV criteria for methamphetamine dependence and able to provide informed consent. - We intend to oversample Latinos in order to achieve a group with sufficient power to compare to non-Latinos. Our goal is to recruit 75 Latinos and 75 non-Latinos. Exclusion Criteria: - Persons not meeting the DSM-IV criteria for methamphetamine dependence and persons unable to complete informed consent.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Saint Francis Medical Center Alcohol and Drug Treatment Center Grand Island Nebraska
United States Catholic Charities - Campus for Hope Omaha Nebraska

Sponsors (1)

Lead Sponsor Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rural v urban persons with methamphetamine dependence entering SUD treatment Compare socio-demographic, bio-psychosocial and behavioral risk and protective factors between rural and urban persons with methamphetamine dependence entering SUD treatment. Year 1
Secondary Latino v non-Latino persons with methamphetamine dependence Compare methamphetamine dependence between Latino and non-Latino populations and examine methamphetamine dependence among urban and rural Latino populations. Year 2
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