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

This study has been completed.
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00653263
First received: April 1, 2008
Last updated: February 22, 2010
Last verified: February 2010

April 1, 2008
February 22, 2010
August 2006
August 2008   (final data collection date for primary outcome measure)
  • 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).
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00653263 on ClinicalTrials.gov Archive Site
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.
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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
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00653263
Alcohol & Substance Dependence
Yes
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP