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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00653263
Recruitment Status : Completed
First Posted : April 4, 2008
Results First Posted : March 9, 2010
Last Update Posted : March 9, 2010
Information provided by:
University of Arkansas

April 1, 2008
April 4, 2008
October 22, 2009
March 9, 2010
March 9, 2010
August 2006
August 2008   (Final data collection date for primary outcome measure)
  • Methamphetamine Selective Severity Assessment (MSSA) [ Time Frame: Baseline through week 4 ]
    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 ]
    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).
To study the effects of stopping use of methamphetamine and develop assessment tools to better characterize withdrawal effects from stopping use of methamphetamine. [ Time Frame: Intake (Week 1), Week 2 and Week 4 ]
Complete list of historical versions of study NCT00653263 on Archive Site
Hamilton Depression Rating Scale (HAM-D) Rating Score [ Time Frame: 4 weeks ]
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.
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Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study
Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study
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.
Observational Model: Case-Only
Time Perspective: Prospective
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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.
  • Methamphetamine Dependence
  • Methamphetamine Withdrawal
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Methamphetamine dependent
Methamphetamine dependent participants admitted to Recovery Centers of Arkansas
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2008
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Alcohol & Substance Dependence
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Michael Mancino, M.D. Primary Investigator, University of Arkansas for Medical Sciences
University of Arkansas
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Principal Investigator: Michael J Mancino, M.D. University of Arkansas
Study Chair: Alison Oliveto, PhD University of Arkansas
University of Arkansas
February 2010