NCT00135785

Brief Summary

Methamphetamine is an addictive stimulant drug that strongly activates certain parts of the brain. The purpose of this study is to determine the effectiveness of bupropion in combination with behavioral therapy for the treatment of methamphetamine addiction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

January 12, 2017

Status Verified

September 1, 2009

Enrollment Period

1.6 years

First QC Date

August 23, 2005

Last Update Submit

January 11, 2017

Conditions

Methamphetamine

Outcome Measures

Primary Outcomes (2)

  • Addiction severity, Week 16

  • Drug use, Week 16

Study Arms (2)

1

ACTIVE COMPARATOR

Bupropion

Drug: Bupropion

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

BupropionDRUG
1
PlaceboDRUG
2

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets DSM-IV criteria for methamphetamine dependence
  • Females must use an effective method of contraception

You may not qualify if:

  • Current neurological disorder (e.g., organic brain disease, dementia)
  • Major psychiatric disorder unrelated to substance abuse, such as schizophrenia or bipolar disorder (assessed by the SCID and a medical history)
  • Suicide attempt within the month prior to enrollment and/or currently suicidal (assessed by the SCID and the BDI II)
  • Currently on prescription medication that might interact with the study drug
  • Currently dependent on cocaine, opiates, alcohol, or benzodiazepines, as defined by DSM-IV-TR criteria
  • History of alcohol dependence within past three years
  • History of seizure disorders
  • History of anorexia or bulimia
  • Current hypertension uncontrolled by medication
  • History of sensitivity to bupropion
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCLA Medical Center

Los Angeles, California, 90024, United States

Location

Rancho Cucamonga Clinic

Rancho Cucamonga, California, 91730, United States

Location

MeSH Terms

Interventions

Bupropion

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Steve Shoptaw, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 26, 2005

Study Start

October 1, 2005

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

January 12, 2017

Record last verified: 2009-09

Locations

US(2)