Study of Medical Treatment for Methamphetamine Addiction (BUP PGx)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Keith Heinzerling, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00833443
First received: January 30, 2009
Last updated: January 10, 2014
Last verified: January 2014
Results First Received: January 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Methamphetamine
Amphetamine Dependence
Pharmacogenetics
Methamphetamine Dependence
Substance Abuse
Intervention: Drug: Bupropion

  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
Participants were recruited via advertisements and outreach in the Los Angeles area

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bupropion

Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.

Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.

Sugar Pill Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.

Participant Flow:   Overall Study
    Bupropion     Sugar Pill  
STARTED     41     43  
COMPLETED     21     15  
NOT COMPLETED     20     28  



  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
Bupropion

Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.

Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.

Sugar Pill Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Bupropion     Sugar Pill     Total  
Number of Participants  
[units: participants]
  41     43     84  
Age  
[units: years]
Mean ± Standard Deviation
  38.6  ± 10.1     38.1  ± 10.3     38.4  ± 10.1  
Gender  
[units: participants]
     
Female     7     9     16  
Male     34     34     68  
Race/Ethnicity, Customized  
[units: participants]
     
Hispanic     18     17     35  
White     15     13     28  
African American     7     10     17  
Asian/Pacific Islander     1     3     4  
Region of Enrollment  
[units: participants]
     
United States     41     43     84  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Treatment Effectiveness Score   [ Time Frame: 12 weeks ]

2.  Primary:   End of Treatment Methamphetamine Abstinence   [ Time Frame: 12 weeks ]

3.  Secondary:   Treatment Retention   [ Time Frame: 12 weeks ]

4.  Post-Hoc:   End of Treatment Methamphetamine Abstinence   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Keith Heinzerling MD
Organization: UCLA
phone: 323-461-3106
e-mail: kheinzerling@mednet.ucla.edu


No publications provided


Responsible Party: Keith Heinzerling, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00833443     History of Changes
Other Study ID Numbers: KH_K23, P50DA018185, K23DA023558, DPMC
Study First Received: January 30, 2009
Results First Received: January 10, 2014
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration
United States: NIH/NIDA
California: Research Advisory Board of California
California: UCLA Data Safety and Monitoring Board for Addiction Medicine