A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence

NCT00538655 | Completed Phase 2 DMC

• 1 other identifier: 27.004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Patients treated for methamphetamine dependence have high rates of relapse, and no pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d, l-2-\[(diphenylmethyl) sulfinyl\] acetamide) is a novel wake- and vigilance- promoting agent that is chemically and pharmacologically dissimilar to CNS stimulants such as the amphetamines, methylphenidate, and pemoline. It is well tolerated and has low abuse liability compared to CNS stimulants. Modafinil is FDA approved for a variety of sleep disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to reduce cocaine use in dependent users, and is safe when co-administered with intravenous methamphetamine. We will conduct a pilot, open-label clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence. Specific Aims:

1. 1.Determine the safety of modafinil in the treatment of methamphetamine dependence.
2. 2.Determine the efficacy of modafinil in the treatment of methamphetamine dependence.
3. 3.Assess the effect of modafinil on cognitive function in methamphetamine users.
4. 4.Assess the effect of modafinil on methamphetamine withdrawal symptoms.
5. 5.Compare the validity of a cellular telephone-based reporting system for assessing medication regimen adherence to conventional electronic medication monitoring.
6. 6.Modafinil will be as safe and well tolerated as placebo in a comparison group from another study.
7. 7.Subjects given modafinil will use less methamphetamine than subjects given placebo.
8. 8.Subjects given modafinil with demonstrate improvements in cognitive function when compared to subjects given placebo.
9. 9.Subjects given modafinil will have reduced withdrawal symptoms when compared to subjects given placebo.
10. 10.Adherence will be recorded more accurately by cellular telephone than by conventional electronic medication monitoring.

Conditions

Methamphetamine Addiction

Keywords

amphetamine; methamphetamine; addition; treatment study; drug use; modafinil

Outcome Measures

Primary Outcomes (1)

• MA (-) urine samples

  multiple

Study Arms (1)

modafinil

EXPERIMENTAL

Drug: modafinil

Interventions

modafinil DRUG

400mg vs. 200mg (PO) daily

Also known as: Provigil

modafinil

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 50 years
• Patient is agreeable to conditions of study and signs consent form
• Fluency in English
• Contact site for additional information.

Sponsors & Collaborators

• California Pacific Medical Center Research Institute: lead

Study Sites (1)

CPMC - St. Luke's Hospital ~ 7th Floor/ Addiction Pharmacology Research Lab

San Francisco, California, 94110, United States

Location

MeSH Terms

Interventions

Modafinil

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gantt Galloway, Pharm D.

  California Pacific Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: October 2, 2007
• First Posted: October 3, 2007
• Study Start: January 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: June 1, 2011
• Last Updated: June 3, 2013

Record last verified: 2013-05

Locations

US (1)