Evaluation of Modafinil as a Cocaine Treatment Medication and Interactions With Cocaine - 1

Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions With Intravenous Cocaine

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00033046

Enrollment

Registered

2002-04-08

Start date

2001-06-30

Completion date

2002-04-30

Last updated

2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine-Related Disorders, Drug Administration Schedule, Infusions, Intravenous

Brief summary

The purpose of this study is to evaluate modafinil, a cocaine treatment medication, and its interactions with intravenous (IV) cocaine.

Detailed description

Placebo-controlled, escalating dose drug interaction study using a total of 12 cocaine users at a single site. Study duration will include four infusion sessions: 1) screening/baseline; 2) baseline; 3) 400mg/day steady-state modafinil; 4) 800 mg/day steady state modafinil. Infusion session will be 2 days in duration.

Interventions

DRUGModafinil

Study design

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

Dependent on cocaine; non-treatment seeking; male or female; DSM-4 criteria for cocaine abuse or dependence; at least 18 years of age but no older than 45 non-pregnant females using adequate birth control; capable of providing written informed consent; able to comply with protocol requirements.

Exclusion criteria

Additional criteria available during screening at the site

Design outcomes

Primary

Measure	Time frame
pharmacokinetic parmaters at steady state	—
BP, HR	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026