Acceptability of Pharmacologic Treatment for Methamphetamine Dependence Among MSM

This study has been completed.
Sponsor:
Collaborators:
Public Health Foundation Enterprises, Inc.
Information provided by (Responsible Party):
Phillip Coffin, MD, MIA, San Francisco Department of Public Health
ClinicalTrials.gov Identifier:
NCT00318409
First received: April 24, 2006
Last updated: October 9, 2014
Last verified: October 2014
Results First Received: April 24, 2013  
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: Bupropion
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
Participants were actively recruited at the municipal STD and HIV clinics, and by street outreach. Recruitment flyers were posted at locations of active recruitment, in local newspapers and in print media and on social networking websites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After informed consent, participants were screened in two screening visits, with lab and HIV testing, medical history and physical exam, and urine meth testing.

Reporting Groups
  Description
Bupropion Bupropion XL 300mg daily
Placebo Placebo 300mg daily

Participant Flow:   Overall Study
    Bupropion     Placebo  
STARTED     20     10  
COMPLETED     18     9  
NOT COMPLETED     2     1  



  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 XL 300mg daily
Placebo Placebo 300mg daily
Total Total of all reporting groups

Baseline Measures
    Bupropion     Placebo     Total  
Number of Participants  
[units: participants]
  20     10     30  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     10     30  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     0     0     0  
Male     20     10     30  



  Outcome Measures
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1.  Primary:   Feasibility: Proportion of Persons Screened Who Are Eligible and Enrolled   [ Time Frame: At Enrollment ]

2.  Primary:   Feasibility: Proportion of Scheduled Study Visits Completed   [ Time Frame: 12 weeks ]

3.  Primary:   Feasibility: Proportion of Urine Samples Collected   [ Time Frame: 12 weeks ]

4.  Primary:   Feasibility: Participants Who Completed the Trial   [ Time Frame: 12 weeks ]

5.  Primary:   Tolerability: Comparison of Adverse Events in the Bupropion and Placebo Arms.   [ Time Frame: throughout study ]

6.  Primary:   Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by MEMS (Medication Event Monitoring System) Caps Openings   [ Time Frame: 12 weeks ]

7.  Primary:   Acceptability: Adherence to Daily Bupropion and Placebo, as Determined by Self-report   [ Time Frame: 12 weeks ]

8.  Primary:   Acceptability: Proportion of Participants Discontinuing Medication in Both Arms   [ Time Frame: 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Moupali Das, MD, MPH
Organization: San Francisco Department of Public Health
phone: 415-437-6204
e-mail: moupali.das@sfdph.org


Publications of Results:

Responsible Party: Phillip Coffin, MD, MIA, San Francisco Department of Public Health
ClinicalTrials.gov Identifier: NCT00318409     History of Changes
Other Study ID Numbers: R21DA021090-1, R21DA021090
Study First Received: April 24, 2006
Results First Received: April 24, 2013
Last Updated: October 9, 2014
Health Authority: United States: Federal Government