A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence

NCT ID: NCT00630682

Last Updated: 2013-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2011-08-31

Brief Summary

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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

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Conditions

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Methamphetamine Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Dextroamphetamine

Active drug

Group Type ACTIVE_COMPARATOR

Dextroamphetamine

Intervention Type DRUG

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

Placebo

Placebo of drug

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

9 weeks of placebo 60mg capsules QD.

Interventions

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Dextroamphetamine

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

Intervention Type DRUG

Placebo

9 weeks of placebo 60mg capsules QD.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18-50 yrs. old

Exclusion Criteria

* pregnant or lactating females

* Contact site for additional information
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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California Pacific Medical Center Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Gantt Galloway, PharmD

Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gantt Galloway, PharmD

Role: PRINCIPAL_INVESTIGATOR

Addiction Pharmacology Research Laboratory

Locations

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

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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P50DA018179

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25.139

Identifier Type: -

Identifier Source: org_study_id

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