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

This study has been completed.

Study NCT00653263 Information provided by University of Arkansas

First Received on April 1, 2008. Last Updated on February 22, 2010 History of Changes

Results First Received: October 22, 2009

Study Type:	Observational
Study Design:	Observational Model: Case-Only; Time Perspective: Prospective
Conditions:	Methamphetamine Dependence Methamphetamine Withdrawal

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 13 participants were recruited for enrollment in study entry.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 5 participants did not meet study criteria and did not enter the study proper, leaving a total of 8 eligible subjects.

Reporting Groups

	Description
Methamphetamine Dependent	Methamphetamine dependent participants admitted to Recovery Centers of Arkansas

Participant Flow: Overall Study

[1]	1 dropped out of treatment and the other had untreated hypertension

Baseline Characteristics

Reporting Groups

	Description
Methamphetamine Dependent	Methamphetamine dependent participants admitted to Recovery Centers of Arkansas

Baseline Measures

	Methamphetamine Dependent
Number of Participants [units: participants]	8
Age [units: participants]
<=18 years	0
Between 18 and 65 years	8
>=65 years	0
Age [units: years] Mean ± Standard Deviation	32.67 ± 5.8
Gender [units: participants]
Female	5
Male	3
Region of Enrollment [units: participants]
United States	8

Outcome Measures

1. Primary:

Methamphetamine Selective Severity Assessment (MSSA) [ Time Frame: Baseline through week 4 ]

Show Outcome Measure 1

2. Primary:

Methamphetamine Withdrawal Assessment (MAWA) [ Time Frame: Baseline through week 4 ]

Show Outcome Measure 2

3. Secondary:

Hamilton Depression Rating Scale (HAM-D) Rating Score [ Time Frame: 4 weeks ]

Show Outcome Measure 3

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The small sample size (N=6) is a significant limitation of the current study.

Results Point of Contact:

Name/Title: Michael J Mancino
Organization: UArkansas
phone: 501-526-8442
e-mail: mjmancino@uams.edu

No publications provided

Responsible Party:	Michael Mancino, M.D. Primary Investigator, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier:	NCT00653263 History of Changes
Other Study ID Numbers:	Alcohol & Substance Dependence
Study First Received:	April 1, 2008
Results First Received:	October 22, 2009
Last Updated:	February 22, 2010
Health Authority:	United States: Institutional Review Board