NCT00630682

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

2.5 years

First QC Date

February 28, 2008

Last Update Submit

May 30, 2013

Conditions

Methamphetamine Addiction

Keywords

MethamphetamineDrug AbuseDrug TreatmentAddictionMethTreatment for Methamphetamine Dependence

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Dextroamphetamine

ACTIVE COMPARATOR

Active drug

Drug: Dextroamphetamine

Placebo

PLACEBO COMPARATOR

Placebo of drug

Drug: Placebo

Interventions

DextroamphetamineDRUG

1 week placebo and 8 weeks 60mg d-AMP QD.

Dextroamphetamine
PlaceboDRUG

9 weeks of placebo 60mg capsules QD.

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • yrs. old

You may not qualify if:

  • pregnant or lactating females
  • Contact site for additional information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CPMC-St. Luke's Campus-Addiction Pharmacology Research Laboratory

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersBehavior, Addictive

Interventions

Dextroamphetamine

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

AmphetamineAmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Gantt Galloway, PharmD

    Addiction Pharmacology Research Laboratory

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 7, 2008

Study Start

September 1, 2006

Primary Completion

March 1, 2009

Study Completion

August 1, 2011

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations

US(1)