A Pilot Trial of Modafinil for Treatment of Methamphetami... | NCT00538655

Studies
A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence

NCT00538655

Sponsor

California Pacific Medical Center Research Institute

Status

Completed

Last Update Posted

Jun 3, 2013Estimated

Enrollment

20Actual

Phase

Phase 2

Conditions

Methamphetamine Addiction

Interventions

modafinil

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Jun 2011Actual

First Submitted Date

Oct 2, 2007

First Submission Date that Met QC Criteria

Oct 2, 2007

First Posted Date

Oct 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2013

Last Update Posted Date

Jun 3, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gantt Galloway, PharmD, Scientist, California Pacific Medical Center Research InstitutePrincipal Investigator

Lead Sponsor

California Pacific Medical Center Research InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Determine the safety of modafinil in the treatment of methamphetamine dependence.
Determine the efficacy of modafinil in the treatment of methamphetamine dependence.
Assess the effect of modafinil on cognitive function in methamphetamine users.
Assess the effect of modafinil on methamphetamine withdrawal symptoms.
Compare the validity of a cellular telephone-based reporting system for assessing medication regimen adherence to conventional electronic medication monitoring.

Hypotheses:

Modafinil will be as safe and well tolerated as placebo in a comparison group from another study.
Subjects given modafinil will use less methamphetamine than subjects given placebo.
Subjects given modafinil with demonstrate improvements in cognitive function when compared to subjects given placebo.
Subjects given modafinil will have reduced withdrawal symptoms when compared to subjects given placebo.
Adherence will be recorded more accurately by cellular telephone than by conventional electronic medication monitoring.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
modafinil	Experimental		Drug: modafinil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
modafinil	Drug	400mg vs. 200mg (PO) daily	modafinil	Provigil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MA (-) urine samples		multiple

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gantt Galloway, Pharm D.	California Pacific Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CPMC - St. Luke's Hospital ~ 7th Floor/ Addiction Pharmacology Research Lab		San Francisco	California	94110	United States

Intervention Browse Module

MeSH Terms

ID	Term
D000077408	Modafinil

Ancestor Terms

ID	Term
D001559	Benzhydryl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

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