NCT00630097

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. 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 coadministered with intravenous methamphetamine. We will conduct a randomized dose ranging clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 22, 2011

Status Verified

June 1, 2010

Enrollment Period

1.5 years

First QC Date

February 27, 2008

Last Update Submit

June 21, 2011

Conditions

Substance DependenceAmphetamine Dependence

Keywords

methamphetamine addiction, meth dependence

Outcome Measures

Primary Outcomes (1)

  • Methamphetamine-negative urine samples will be analyzed using a generalized estimating equation model

    end of study

Interventions

modafinilDRUG

Modafinil, 100mg, 400mg, or 600 mg tablets QD for 4 weeks.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CPMC

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersAmphetamine-Related Disorders

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Gantt Galloway, PharmD

    California Pacific Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 27, 2008

First Posted

March 6, 2008

Study Start

December 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 22, 2011

Record last verified: 2010-06

Locations

US(1)