Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study
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Purpose
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.
| Condition |
|---|
|
Methamphetamine Dependence Methamphetamine Withdrawal |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study |
- Methamphetamine Selective Severity Assessment (MSSA) [ Time Frame: Baseline through week 4 ] [ Designated as safety issue: No ]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.
- Methamphetamine Withdrawal Assessment (MAWA) [ Time Frame: Baseline through week 4 ] [ Designated as safety issue: No ]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).
- Hamilton Depression Rating Scale (HAM-D) Rating Score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 8 |
| Study Start Date: | August 2006 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Methamphetamine dependent
Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
We will enroll 20 methamphetamine dependent individuals ages 18-65 recruited from those admitted to the Recovery Centers of Arkansas in North Little Rock.
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
Contacts and Locations| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| Principal Investigator: | Michael J Mancino, M.D. | University of Arkansas |
| Study Chair: | Alison Oliveto, PhD | University of Arkansas |
More Information
Additional Information:
No publications provided
| Responsible Party: | Michael Mancino, M.D. Primary Investigator, University of Arkansas for Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT00653263 History of Changes |
| Other Study ID Numbers: | Alcohol & Substance Dependence |
| Study First Received: | April 1, 2008 |
| Results First Received: | October 22, 2009 |
| Last Updated: | February 22, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Arkansas:
|
methamphetamine drug abuse withdrawal |
Additional relevant MeSH terms:
|
Methamphetamine Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013