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NCT01354470 Clinical Trial

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

Methamphetamine Dependence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01354470
Other study ID # CPMC-APRL-8B
Secondary ID
Status Completed
Phase Phase 2
First received May 12, 2011
Last updated July 1, 2013
Start date October 2011

Study information
Verified date July 2013
Source California Pacific Medical Center Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Age between 18 and 50 years

- Patient is agreeable to conditions of study and signs consent form

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Modafinil
600 mg Modafinil capsule

Locations
Country Name City State
United States New Leaf Treatment Center Lafayette California
United States CPMC Research Institute, St.Luke's Hospital San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
California Pacific Medical Center Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Urine Samples Negative for Methamphetamine Twice weekly for 4 weeks No
See also
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Terminated NCT01813643 - A Comparison of Risperidone and Aripiprazole for Treatment of Patirnts With Methamphetamine-Associated Psychosis Phase 4
Completed NCT01073319 - Rivastigmine as a Treatment for Methamphetamine Dependence Phase 1