Assessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1

Condition(s) targeted: Amphetamine-Related Disorders

Intervention: Modafinil (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Reese Jones, M.D., Principal Investigator, Affiliation: Langley Porter Psychiatric Institute

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

Official title: Double-Blind, Placebo-Controlled Assessment of Interactions Between Intravenous Methamphetamine and Modafinil

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Cardiovascular

Subjective symptoms/Mood Effects

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).

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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

U of CA, San Francisco, San Francisco, California 94143, United States

Starting date: March 2005
Last updated: October 25, 2007