Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study

Conditions
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Methamphetamine Dependence, Methamphetamine Withdrawal

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years old Subjects must have a history of methamphetamine use, with recent use verified by a urine toxicology screen positive for amphetamines Exclusion Criteria: Current diagnosis of drug or alcohol physical dependence (other than methamphetamine or tobacco) Schizophrenia, or bipolar type I disorder Present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that may affect mood ratings Current suicidality or psychosis Pregnancy: hormonal changes during pregnancy can affect mood which might produce a potential confound if pregnant women were enrolled

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Methamphetamine dependent<br>Methamphetamine dependent participants admitted to Recovery Centers of Arkansas | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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methamphetamine, drug abuse, withdrawal