Clinical Trial: Interactions Between Intravenous (IV) Cocaine and Lofexidine
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Phase 1, Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Cocaine and Lofexidine
Brief Summary: The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and treatment with lofexidine.
Detailed Summary: To determine the safety of daily oral lofexidine alone and concurrent with IV cocaine infusions of 20 mg and 40 mg in cocaine-experienced, non-opiate-addicted volunteers.
Sponsor: National Institute on Drug Abuse (NIDA)
Current Primary Outcome: Adverse Event and Cardiovascular Response [ Time Frame: Daily, up to 9 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pharmacokinetics (PK) Parameter of Cocaine and Benzoylecgonine (BE) [ Time Frame: Daily, up to 9 days ]
- PK of Lofexidine [ Time Frame: Daily, up to 9 days ]
- Visual Analog Scale (VAS) [ Time Frame: Daily, up to 9 days ]
- Brief Substance Abuse Craving Scale (BSCA) [ Time Frame: Daily, up to 9 days ]
Original Secondary Outcome: Same as current
Information By: National Institute on Drug Abuse (NIDA)
Dates:
Date Received: June 17, 2010
Date Started: August 2010
Date Completion:
Last Updated: January 10, 2017
Last Verified: August 2016