Assessment of Interactions Between Intravenous Methamphet... | NCT00265278

Studies
Assessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1

NCT00265278

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Unknown status

Last Update Posted

Jan 11, 2017Estimated

Enrollment

Phase

Phase 1

Conditions

Amphetamine-Related Disorders

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

Dec 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 2005

Primary Completion Date

Not provided

Completion Date

Mar 2006

First Submitted Date

Dec 13, 2005

First Submission Date that Met QC Criteria

Dec 13, 2005

First Posted Date

Dec 14, 2005Estimated

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

Jan 10, 2017

Last Update Posted Date

Jan 11, 2017Estimated

Description Module

Brief Summary

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

Detailed Description

The primary aims of this experiment are to determine if there are significant safety interactions between oral modafinil and intravenous methamphetamine. Safety will be assessed by measuring adverse events and cardiovascular responses of heart rate (HR), blood pressure (BP), and electrocardiogram (ECG) and stroke distance (ICG).

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Modafinil	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Please contact site for further details

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Reese Jones, M.D.	Langley Porter Psychiatric Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
U of CA, San Francisco		San Francisco	California	94143	United States

Condition Browse Module

MeSH Terms

ID	Term
D019969	Amphetamine-Related Disorders

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

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

Measure	Description	Time Frame
Cardiovascular
Subjective symptoms/Mood Effects