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.

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Key information

Conditions

Methamphetamine Dependence Chemically-Induced Disorders Mental Disorders Methamphetamine Withdrawal Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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).

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Apr 4, 2008
Registry last updated: Jun 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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