A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence

NCT ID: NCT01354470

Last Updated: 2013-07-02

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Brief Summary

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The proposed study will establish the safety and efficacy of modafinil in the treatment of methamphetamine dependence, as well as assess the affects of modafinil on cognitive function in methamphetamine users and on methamphetamine withdrawal symptoms. In this outpatient trial, methamphetamine- dependent, treatment-seeking subjects will receive modafinil or placebo daily for four weeks, along with weekly Motivational Enhancement Therapy sessions. This study will be conducted at the Addiction \& Pharmacology Laboratory in San Francisco, CA, and at the New Leaf Treatment Center in Lafayette, CA, and is expected to last one year.

Detailed Description

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Conditions

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Methamphetamine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Modafinil

Group Type EXPERIMENTAL

Modafinil

Intervention Type DRUG

600 mg Modafinil capsule

placebo (cornstarch)

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Modafinil

600 mg Modafinil capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 50 years
* Patient is agreeable to conditions of study and signs consent form
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

California Pacific Medical Center

Locations

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New Leaf Treatment Center

Lafayette, California, United States

Site Status

CPMC Research Institute, St.Luke's Hospital

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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CPMC-APRL-8B

Identifier Type: -

Identifier Source: org_study_id

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