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

Methamphetamine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687713
• Other study ID #: MDS Bupropion Meth 0001
• 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

• Methamphetamine Dependence

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