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Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00687713
First received: May 29, 2008
Last updated: February 14, 2017
Last verified: February 2017
Results First Received: December 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Treatment
Condition: Methamphetamine Dependence
Interventions: Drug: Bupropion
Other: 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
No text entered.

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

Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.

Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.

Placebo

Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.

Placebo: Placebo


Participant Flow:   Overall Study
    Bupropion   Placebo
STARTED   100   104 
COMPLETED   68   64 
NOT COMPLETED   32   40 



  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

Subjects received bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.

Bupropion: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.

Placebo

Subjects received a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.

Placebo: Placebo

Total Total of all reporting groups

Baseline Measures
   Bupropion   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 100   104   204 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      100 100.0%      104 100.0%      204 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      37  37.0%      35  33.7%      72  35.3% 
Male      63  63.0%      69  66.3%      132  64.7% 
Region of Enrollment 
[Units: Participants]
     
United States   100   105   205 


  Outcome Measures
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1.  Primary:   Number of Subjects Showing Abstinence   [ Time Frame: Weeks 11 and 12 ]

2.  Secondary:   Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use   [ Time Frame: 30 days ]


  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: Ann Anderson, MD
Organization: National Institute on Drug Abuse
phone: 301-827-5916
e-mail: aanderso@nida.nih.gov


Publications:

Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00687713     History of Changes
Other Study ID Numbers: MDS Bupropion Meth 0001
Study First Received: May 29, 2008
Results First Received: December 22, 2016
Last Updated: February 14, 2017