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Methamphetamine DependenceNCT00882037

Risk and Protective Factors for Rural Methamphetamine Dependence

An observational study of Methamphetamine Dependence, run by University of Nebraska at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Methamphetamine Dependence
How many people
133 participants
Where
2 sitesUnited States
Study dates
12 Dec 2008to 15 Dec 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: This is a study of 150 rural and urban persons in treatment for methamphetamine dependence. We propose to enroll 150 participants (75 rural and 75 urban) over a two year period. Of these 150 participants, 75 will be Latino and 75 non-Latino (approximately 37 rural and 37 urban for each group).

Who may be able to join

  • 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.

Who cannot join

  • Persons not meeting the DSM-IV criteria for methamphetamine dependence and persons unable to complete informed consent.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Saint Francis Medical Center Alcohol and Drug Treatment Center

    Grand Island, Nebraska, 68802-9804

  • Catholic Charities - Campus for Hope

    Omaha, Nebraska, 68104

Other trials in United States

About this study

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.

Read the detailed 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).

Keywords
Methamphetamine Dependence, Substance Abuse Treatment, Rural and Urban, Latino and Non-Latino

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00882037
Study groupRoleWhat they receive
Meth DependenceMethamphetamine Dependence in residential Substance Abuse Treatment Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Year 1

Secondary outcomes (1)
  1. 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.

    Measured: Year 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2009 (estimated)
  2. Study start12 Dec 2008
  3. Primary completion15 Dec 2010
  4. Study completion15 Dec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00882037
Sponsor's protocol ID
0335-08-FB
Status last verified
Sep 2023
First submitted
15 Apr 2009
Last updated
29 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Methamphetamine Dependence, run by University of Nebraska at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rural v urban persons with methamphetamine dependence entering SUD treatment (time frame: Year 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.

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