This trial is active, not recruiting.

Condition amphetamine-related disorders
Treatment modafinil
Phase phase 1
Sponsor National Institute on Drug Abuse (NIDA)
Start date March 2005
End date March 2006
Trial size 16 participants
Trial identifier NCT00265278, NIDA-CPU-0008-1


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

time frame:
Subjective symptoms/Mood Effects
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

Official title Double-Blind, Placebo-Controlled Assessment of Interactions Between Intravenous Methamphetamine and Modafinil
Principal investigator Reese Jones, M.D.
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).
Trial information was received from ClinicalTrials.gov and was last updated in October 2007.
Information provided to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA).