Clinical trial NCT00653263: Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study
Official title: Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Methamphetamine Dependence
Methamphetamine Withdrawal
Keywords: methamphetamine
drug abuse
withdrawal
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2008-04-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Methamphetamine Selective Severity Assessment (MSSA)
timeFrame: Baseline through week 4
measure: Methamphetamine Withdrawal Assessment (MAWA)
timeFrame: Baseline through week 4
Secondary outcomes:
measure: Hamilton Depression Rating Scale (HAM-D) Rating Score
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Michael J Mancino, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arkansas
name: Alison Oliveto, PhD
role: STUDY_CHAIR
References: