Bupropion for the Treatment of Methamphetamine Dependence... | NCT00069251

Studies
Bupropion for the Treatment of Methamphetamine Dependence - 1

NCT00069251

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Completed

Last Update Posted

Jan 12, 2017Estimated

Enrollment

150

Phase

Phase 2

Conditions

Amphetamine-Related Disorders

Interventions

Bupropion

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jul 2003

Primary Completion Date

Not provided

Completion Date

Jun 2005

First Submitted Date

Sep 18, 2003

First Submission Date that Met QC Criteria

Sep 23, 2003

First Posted Date

Sep 24, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2017

Last Update Posted Date

Jan 12, 2017Estimated

Description Module

Brief Summary

The purpose of this study is to assess the efficacy and safety of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence

Detailed Description

A double-blind, placebo-controlled, parallel-group design study in which 100 subjects will be randomly assigned to placebo or bupropion for 12 weeks with follow-up assessments 4 weeks following treatment. Adaptive randomization will be used to balance treatment groups based on gender.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Name	Type	Description	Arm Group Labels	Other Names
Bupropion	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject must have methamphetamine dependence as determined by the DSM-IV diagnosis
Subject must be willing to comply with study procedures.
Ability to verbalize understanding of consent form, provide written consent, and verbalize willingness to complete study procedures
Be able to comply with protocol requirements

Exclusion Criteria:

Please contact site for more information.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Rawson, Ph.D.	University of California, Los Angeles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Matrix Institute on Addictions		Costa Mesa	California	92627	United States
South Bay Treatment Center

Condition Browse Module

MeSH Terms

ID	Term
D019969	Amphetamine-Related Disorders

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016642	Bupropion

Ancestor Terms

ID	Term
D011427	Propiophenones
D007659	Ketones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Severity addiction
Methamphetamine use