Aripiprazole Treatment for Methamphetamine Dependence Among High-risk Individuals

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Phillip Coffin, MD, MIA, San Francisco Department of Public Health
ClinicalTrials.gov Identifier:
NCT00497055
First received: July 5, 2007
Last updated: February 5, 2014
Last verified: February 2014
Results First Received: December 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Substance Abuse
HIV Infections
Interventions: Drug: Aripiprazole
Drug: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Aripiprazole Aripiprazole 5mg daily for week one. Aripiprazole 10mg daily for week two. Aripiprazole 20mg daily for weeks three through twelve.
Placebo Placebo (for Aripiprazole) 5mg daily for week one. Placebo (for Aripiprazole) 10mg daily for week two. Placebo (for Aripiprazole) 20mg daily for weeks three through twelve.

Participant Flow:   Overall Study
    Aripiprazole     Placebo  
STARTED     45     45  
COMPLETED     35     40  
NOT COMPLETED     10     5  



  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.
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Reporting Groups
  Description
Aripiprazole aripiprazole daily for 3 months
Placebo placebo daily for 3 months
Total Total of all reporting groups

Baseline Measures
    Aripiprazole     Placebo     Total  
Number of Participants  
[units: participants]
  45     45     90  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     45     45     90  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  37.4  ± 12.3     40  ± 8.9     38.7  ± 10.8  
Gender  
[units: participants]
     
Female     6     5     11  
Male     39     40     79  
Region of Enrollment  
[units: participants]
     
United States     45     45     90  



  Outcome Measures
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1.  Primary:   To Test the Hypothesis That Aripiprazole 20 mg Daily Will Reduce Methamphetamine Use Significantly More Than Placebo Among Methamphetamine-dependent Individuals.   [ Time Frame: Final study visit at week 12 ]

2.  Primary:   To Measure the Acceptability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, by Determining (Via Electronic Pill Caps [MEMS or Medication Event Monitoring System]) Medication Adherence to Aripiprazole and Placebo.   [ Time Frame: Adherence as determined by MEMS (throughout study, up to 12 weeks) ]

3.  Primary:   To Measure the Safety and Tolerability of Aripiprazole and Placebo Among Methamphetamine-dependent Individuals, as Determined by the Number of Adverse Clinical Events in the Aripiprazole and Placebo Arms.   [ Time Frame: Total reported adverse events (throughout study, up to 12 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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Phillip O. Coffin, Director of Substance Use Research
Organization: San Francisco Department of Public Health
phone: 415-437-6282
e-mail: phillip.coffin@sfdph.org


Publications of Results:

Responsible Party: Phillip Coffin, MD, MIA, San Francisco Department of Public Health
ClinicalTrials.gov Identifier: NCT00497055     History of Changes
Other Study ID Numbers: 1 R01 DA022190-01, 1R01DA022190-01, 1R01DA023387-01, DPMC
Study First Received: July 5, 2007
Results First Received: December 12, 2012
Last Updated: February 5, 2014
Health Authority: United States: Federal Government