NCT00265278

Brief Summary

The purpose of this study is to assess the potential interactions between intravenous methamphetamine and oral Modafinil.

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
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2005

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

Study Start

First participant enrolled

March 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

January 11, 2017

Status Verified

December 1, 2005

First QC Date

December 13, 2005

Last Update Submit

January 10, 2017

Conditions

Amphetamine-Related Disorders

Outcome Measures

Primary Outcomes (2)

  • Cardiovascular

  • Subjective symptoms/Mood Effects

Interventions

ModafinilDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • normotensive
  • good physical and mental health
  • body mass index between 18 and 30
  • if female, using an acceptable method of contraception and are not pregnant
  • able to give voluntary informed consent

You may not qualify if:

  • Please contact site for further details

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U of CA, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Amphetamine-Related Disorders

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Reese Jones, M.D.

    Langley Porter Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

December 13, 2005

First Posted

December 14, 2005

Study Start

March 1, 2005

Study Completion

March 1, 2006

Last Updated

January 11, 2017

Record last verified: 2005-12

Locations

US(1)