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 ]

Adverse Events will measured during follow-up at weeks 14-21


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