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

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ClinicalTrials.gov Identifier: NCT00653263
Recruitment Status : Completed
First Posted : April 4, 2008
Results First Posted : March 9, 2010
Last Update Posted : March 9, 2010
Sponsor:
Information provided by:
University of Arkansas

Study Description
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Brief Summary:
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 or disease
Methamphetamine Dependence Methamphetamine Withdrawal

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.
Study Design
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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study
Study Start Date : August 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Groups and Cohorts
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Group/Cohort
Methamphetamine dependent
Methamphetamine dependent participants admitted to Recovery Centers of Arkansas


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will enroll 20 methamphetamine dependent individuals ages 18-65 recruited from those admitted to the Recovery Centers of Arkansas in North Little Rock.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653263


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Michael J Mancino, M.D. University of Arkansas
Study Chair: Alison Oliveto, PhD University of Arkansas
More Information
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Additional Information:

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Responsible Party: Michael Mancino, M.D. Primary Investigator, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00653263    
Other Study ID Numbers: Alcohol & Substance Dependence
First Posted: April 4, 2008    Key Record Dates
Results First Posted: March 9, 2010
Last Update Posted: March 9, 2010
Last Verified: February 2010
Keywords provided by University of Arkansas:
methamphetamine
drug abuse
withdrawal