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

This study has been completed.
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00653263
First received: April 1, 2008
Last updated: February 22, 2010
Last verified: February 2010
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
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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
    Methamphetamine Dependent  
STARTED     8 [1]
COMPLETED     6  
NOT COMPLETED     2  
Withdrawal by Subject                 1  
Physician Decision                 1  
[1] 1 dropped out of treatment and the other had untreated hypertension



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the 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