A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence

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.

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Key information

Conditions

Methamphetamine Addiction Behavior Behavior, Addictive Chemically-Induced Disorders Compulsive Behavior Impulsive Behavior Mental Disorders Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18-50 yrs. old

Exclusion criteria

pregnant or lactating females

Contact site for additional information

Treatment and study plan

Dextroamphetamine

Drug

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

Placebo

Drug

9 weeks of placebo 60mg capsules QD.

Primary outcomes

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)

Time frame: Twice per week for 8 weeks

Sponsors and collaborators

Lead sponsor

California Pacific Medical Center Research Institute

Other

Registry information

Acronym: 1D

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2011
First posted: Mar 7, 2008
Registry last updated: Jun 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed