Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study - Full Text View

Purpose

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

Methamphetamine Dependence
Methamphetamine Withdrawal

MedlinePlus related topics:

Methamphetamine

ChemIDplus related topics:

Methamphetamine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

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

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	August 2006
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653263

Locations


United States, Arkansas
	University of Arkansas for Medical Sciences	Recruiting
	Little Rock, Arkansas, United States, 72205
	Contact: Michael J Mancino, M.D. 501-526-7969 MancinoMichaelJ@uams.edu
	Contact: Amy Glenn (501) 526-7969 ALGlenn@uams.edu
	Principal Investigator: Michael J Mancino, M.D.
	Principal Investigator: Alison Oliveto, PhD
	Principal Investigator: William Gentry, M.D.
	Principal Investigator: Warren Bickel, PhD
	Sub-Investigator: Christopher Cargile, M.D.
	Sub-Investigator: Mohit Chopra, M.D.

Sponsors and Collaborators

University of Arkansas

Investigators


Principal Investigator:	Michael J Mancino, M.D.	University of Arkansas

Study Chair:	Alison Oliveto, PhD	University of Arkansas

More Information

Institutional Center for Addiction Research site This link exits the ClinicalTrials.gov site

participant research link This link exits the ClinicalTrials.gov site

Responsible Party:	University of Arkansas for Medical Sciences ( Michael Mancino, M.D. Primary Investigator )
Study ID Numbers:	Alcohol & Substance Dependence
First Received:	April 1, 2008
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00653263
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Arkansas:

methamphetamine

drug abuse

withdrawal

Study placed in the following topic categories:

Methamphetamine

Dopamine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Sympathomimetics

Adrenergic Uptake Inhibitors

Physiological Effects of Drugs

Central Nervous System Stimulants

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Dopamine Agents

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	University of Arkansas
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00653263