NCT01354470

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Last Updated

July 2, 2013

Status Verified

July 1, 2013

Enrollment Period

1.3 years

First QC Date

May 12, 2011

Last Update Submit

July 1, 2013

Conditions

Methamphetamine Dependence

Keywords

MethMethamphetamine AddictionMethamphetamine TreatmentModafinil

Outcome Measures

Primary Outcomes (1)

  • Urine Samples Negative for Methamphetamine

    Twice weekly for 4 weeks

Study Arms (2)

Modafinil

EXPERIMENTAL
Drug: Modafinil

placebo (cornstarch)

PLACEBO COMPARATOR

Interventions

ModafinilDRUG

600 mg Modafinil capsule

Modafinil

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 (2)

New Leaf Treatment Center

Lafayette, California, 94549, United States

Location

CPMC Research Institute, St.Luke's Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Interventions

Modafinil

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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 17, 2011

Study Start

October 1, 2011

Primary Completion

February 1, 2013

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations

US(2)