A Randomized, Placebo-Controlled Trial of Modafinil for M... | NCT01354470

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

NCT01354470

Sponsor

California Pacific Medical Center Research Institute

Status

Completed

Last Update Posted

Jul 2, 2013Estimated

Enrollment

72Estimated

Phase

Phase 2

Conditions

Methamphetamine Dependence

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

Jul 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

Oct 2011

Primary Completion Date

Feb 2013Actual

Completion Date

Not provided

First Submitted Date

May 12, 2011

First Submission Date that Met QC Criteria

May 13, 2011

First Posted Date

May 17, 2011Estimated

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

Jul 1, 2013

Last Update Posted Date

Jul 2, 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

Description Module

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.

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

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Modafinil	Experimental		Drug: Modafinil
placebo (cornstarch)	Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Modafinil	Drug	600 mg Modafinil capsule	Modafinil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Urine Samples Negative for Methamphetamine		Twice weekly for 4 weeks

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

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, PharmD	California Pacific Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New Leaf Treatment Center		Lafayette	California	94549	United States
CPMC Research Institute, St.Luke's Hospital

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

Browse Leaves

Not provided

Browse Branches

Not provided