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| ID | Type | Description | Link |
|---|---|---|---|
| Alcohol & Substance Dependence | Other Identifier | Other |
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Methamphetamine use has escalated in recent years. Methamphetamine use has also spread throughout the country. Although much information has been gathered on the treatment of cocaine abuse, very little information has been obtained on the treatment of methamphetamine abuse. One of the first steps in developing appropriate treatment is to examine the effects of stopping a particular substance's use on individuals abusing that substance. To date this has not been well studied for people abusing methamphetamine. The purpose of this study is to better understand and develop accurate ways of measuring symptoms associated with stopping the use of methamphetamine in people that are abusing methamphetamine. If the withdrawal symptoms are able to be effectively measured, this will help to develop treatments targeted at alleviating these symptoms. These symptoms are often associated with relapse to use of that substance.
The primary aim of this 4 week observational study is to examine and characterize the withdrawal symptoms experienced by methamphetamine abusers who are recently abstinent from methamphetamine. The period of drug or substance withdrawal is often cited as the time during which risk of relapse use of that substance is very high. Therefore it is highly important to characterize specifically the withdrawal syndrome associated with cessation of methamphetamine use. This study will demonstrate our ability to recruit and work with this methamphetamine dependent population. In addition it will allow for the collection of pilot data to assist in selecting appropriate assessment tools in a submission of an RO1 grant for well-controlled studies characterizing methamphetamine withdrawal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methamphetamine dependent | Methamphetamine dependent participants admitted to Recovery Centers of Arkansas |
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| Measure | Description | Time Frame |
|---|---|---|
| Methamphetamine Selective Severity Assessment (MSSA) | Methamphetamine Selective Severity Assessment (MSSA) is an 18 item questionnaire assessing withdrawal symptoms with each question measured on a scale from 0(best score)-7(worst score) for a range in scores from 0(best score)-126(worst score). Higher scores indicate more severe withdrawal symptoms. | Baseline through week 4 |
| Methamphetamine Withdrawal Assessment (MAWA) | The Methamphetamine Withdrawal Assessment (MAWA) is a 13 item questionnaire which measures symptoms of methamphetamine withdrawal on a scale from 0(best score)-4(worst score). The total score ranges from 0(best score)-52(worst score). | Baseline through week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale (HAM-D) Rating Score | Hamilton Depression rating scale (HAM-D)is a scale that covers 21 symptoms with a total score of 0(best score)-62 (worst score) and a cutoff for moderate depression of 15 or above. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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We will enroll 20 methamphetamine dependent individuals ages 18-65 recruited from those admitted to the Recovery Centers of Arkansas in North Little Rock.
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Mancino, M.D. | University of Arkansas | Principal Investigator |
| Alison Oliveto, PhD | University of Arkansas | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
A total of 5 participants did not meet study criteria and did not enter the study proper, leaving a total of 8 eligible subjects.
A total of 13 participants were recruited for enrollment in study entry.
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| ID | Title | Description |
|---|---|---|
| FG000 | Methamphetamine Dependent | Methamphetamine dependent participants admitted to Recovery Centers of Arkansas |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Methamphetamine Dependent | Methamphetamine dependent participants admitted to Recovery Centers of Arkansas |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Methamphetamine Selective Severity Assessment (MSSA) | Methamphetamine Selective Severity Assessment (MSSA) is an 18 item questionnaire assessing withdrawal symptoms with each question measured on a scale from 0(best score)-7(worst score) for a range in scores from 0(best score)-126(worst score). Higher scores indicate more severe withdrawal symptoms. | Posted | Mean | Standard Deviation | "units on a scale" | Baseline through week 4 |
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Adverse events were collected for the entire duration of the study 18 months.
No adverse events were identified as this was an observational study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methamphetamine Dependent | Methamphetamine dependent participants admitted to Recovery Centers of Arkansas |
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The small sample size (N=6) is a significant limitation of the current study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael J Mancino | UArkansas | 501-526-8442 | mjmancino@uams.edu |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Methamphetamine Withdrawal Assessment (MAWA) | The Methamphetamine Withdrawal Assessment (MAWA) is a 13 item questionnaire which measures symptoms of methamphetamine withdrawal on a scale from 0(best score)-4(worst score). The total score ranges from 0(best score)-52(worst score). | Posted | Mean | Standard Deviation | "Units on a scale" | Baseline through week 4 |
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| Secondary | Hamilton Depression Rating Scale (HAM-D) Rating Score | Hamilton Depression rating scale (HAM-D)is a scale that covers 21 symptoms with a total score of 0(best score)-62 (worst score) and a cutoff for moderate depression of 15 or above. | Posted | Mean | Standard Deviation | "Units on a scale" | 4 weeks |
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| 8 |
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| 8 |
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