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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00687713
Other study ID # MDS Bupropion Meth 0001
Secondary ID
Status Completed
Phase Phase 2
First received May 29, 2008
Last updated June 29, 2015
Start date May 2008
Est. completion date May 2011

Study information

Verified date May 2011
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to the start of signing consent.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Must have a DSM-IV diagnosis of methamphetamine dependence as determined by MINI

- Must have at least 1 amphetamine or methamphetamine positive urine specimen after the start of screening and before randomization or provide information to verify recent use if a positive urine sample can't be obtained

- Must report using methamphetamine for 29 days or less during the 30 day period prior signing consent using the timeline follow-back method

- Must be willing and able to comply with study procedures

- Must be able to verbalize and understand consent forms and provide written informed consent

- Must be seeking treatment for methamphetamine dependence

Exclusion Criteria:

- Please contact study site for more information

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina
United States Iowa Luther Hospital Des Moines Iowa
United States Pacific Addiction Research Center - U of Hawaii Honolulu Hawaii
United States U of Kansas Medical Center Kansas City Missouri
United States UCLA Integrated Substance Abuse Program Los Angeles California
United States New York University New York New York
United States VA Salt Lake City Health Care System Salt Lake City Utah
United States University of Texas Health Science At San Antonio San Antonio Texas
United States South Bay Treatment Center San Diego California
United States Addiction and Pharmacology Research Laboratory San Francisco California
United States Friends Research Institute Torrance California
United States Matrix Institute Woodland Hills California

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Anderson AL, Li SH, Markova D, Holmes TH, Chiang N, Kahn R, Campbell J, Dickerson DL, Galloway GP, Haning W, Roache JD, Stock C, Elkashef AM. Bupropion for the treatment of methamphetamine dependence in non-daily users: a randomized, double-blind, placebo-controlled trial. Drug Alcohol Depend. 2015 May 1;150:170-4. doi: 10.1016/j.drugalcdep.2015.01.036. Epub 2015 Feb 7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Abstinence Weeks 11 and 12 No
Secondary Overall reduction of use (sustained abstinence) 21 days No
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