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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01354470

Enrollment

Registered

2011-05-17

Start date

2011-10-31

Completion date

Unknown

Last updated

2013-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methamphetamine Dependence

Keywords

Meth, Methamphetamine Addiction, Methamphetamine Treatment, Modafinil

Brief summary

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.

Interventions

DRUGModafinil

600 mg Modafinil capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Urine Samples Negative for Methamphetamine	Twice weekly for 4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026