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.
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
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).
- Conditions
- Methamphetamine Dependence
- 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 group | Role | What they receive |
|---|---|---|
| Meth Dependence | Methamphetamine Dependence in residential Substance Abuse Treatment Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted16 Apr 2009 (estimated)
- Study start12 Dec 2008
- Primary completion15 Dec 2010
- Study completion15 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine DependenceStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen M Grant, MD, Principal investigator, University of Nebraska
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk and Protective Factors for Rural Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT00882037
- Acronym / sponsor ID
- 0335-08-FB
- Conditions
- Methamphetamine Dependence
- Keywords
- Methamphetamine Dependence, Substance Abuse Treatment, Rural and Urban, Latino and Non-Latino
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 12 Dec 2008 (actual)
- Primary completion
- 15 Dec 2010 (actual)
- Study completion
- 15 Dec 2010 (actual)
- First posted
- 16 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meth Dependence | – | –Methamphetamine Dependence in residential Substance Abuse Treatment Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Persons not meeting the DSM-IV criteria for methamphetamine dependence and persons unable to complete informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rural v urban persons with methamphetamine dependence entering SUD treatment
Time frame: Year 1
Compare socio-demographic, bio-psychosocial and behavioral risk and protective factors between rural and urban persons with methamphetamine dependence entering SUD treatment.
1 secondary outcome
Latino v non-Latino persons with methamphetamine dependence
Time frame: Year 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen M Grant, MD principal investigator
University of Nebraska
2 sites in 1 country: see every site and its status.
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.