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

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

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

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Characterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Amphetamine Methamphetamine

U.S. FDA Resources

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:

Enrollment:	10
Study Start Date:	August 2006
Study Completion Date:	August 2008
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
Little Rock, Arkansas, United States, 72205

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

Additional Information:

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

participant research link This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Arkansas for Medical Sciences ( Michael Mancino, M.D. Primary Investigator )
Study ID Numbers:	Alcohol & Substance Dependence
Study First Received:	April 1, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00653263 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Arkansas:

methamphetamine
drug abuse
withdrawal

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Methamphetamine
Dopamine
Adrenergic Agents

Central Nervous System Stimulants
Dopamine Agents
Amphetamine
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Sympathomimetics
Physiological Effects of Drugs
Central Nervous System Stimulants

Pharmacologic Actions
Methamphetamine
Autonomic Agents
Therapeutic Uses
Amphetamine
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009