A Pilot Trial of Dextroamphetamine for Methamphetamine De... | NCT00630682

Studies
A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence

NCT00630682

Sponsor

California Pacific Medical Center Research Institute

Status

Completed

Last Update Posted

Jun 3, 2013Estimated

Enrollment

60Actual

Phase

Phase 2

Conditions

Methamphetamine Addiction

Interventions

Dextroamphetamine
Placebo

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

ID	Type	Description	Link
P50DA018179	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Mar 2009Actual

Completion Date

Aug 2011Actual

First Submitted Date

Feb 28, 2008

First Submission Date that Met QC Criteria

Mar 6, 2008

First Posted Date

Mar 7, 2008Estimated

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

May 30, 2013

Last Update Posted Date

Jun 3, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gantt Galloway, PharmD, Scientist, California Pacific Medical Center Research InstitutePrincipal Investigator

Lead Sponsor

California Pacific Medical Center Research InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the safety and effectiveness dextroamphetamine to help methamphetamine users quit or cut down on their use. The study lasts for 9 weeks. Eligible participants will attend research visits twice per week, and will receive individual counseling sessions once per week for all 9 weeks. 50% of the participants will receive the active medication while the other 50% will receive the placebo (sugar pill). Neither the participant or the study team will know if the participant is receiving the placebo or active drug.

Detailed Description

Not provided

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dextroamphetamine	Active Comparator	Active drug	Drug: Dextroamphetamine
Placebo	Placebo Comparator	Placebo of drug	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dextroamphetamine	Drug	1 week placebo and 8 weeks 60mg d-AMP QD.	Dextroamphetamine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjects treated with dextroamphetamine will have better outcomes than subjects treated with placebo, as indicated by the number of urine samples that do not indicate new use of MA (the primary outcome measure)		Twice per week for 8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-50 yrs. old

Exclusion Criteria:

pregnant or lactating females
- Contact site for additional information

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gantt Galloway, PharmD	Addiction Pharmacology Research Laboratory	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CPMC-St. Luke's Campus-Addiction Pharmacology Research Laboratory		San Francisco	California	94110	United States

Condition Browse Module

MeSH Terms

ID	Term
D019966	Substance-Related Disorders
D016739	Behavior, Addictive

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D003192	Compulsive Behavior
D007175	Impulsive Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003913	Dextroamphetamine

Ancestor Terms

ID	Term
D000661	Amphetamine
D000662	Amphetamines
D010627	Phenethylamines
D005021	Ethylamines

Browse Leaves

Not provided

Browse Branches

Not provided