Interactions Between Intravenous (IV) Cocaine and Lofexidine

January 10, 2017 updated by: National Institute on Drug Abuse (NIDA)

Phase 1, Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Cocaine and Lofexidine

The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and treatment with lofexidine.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • California Pacific Medical Center Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be volunteers who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for cocaine abuse or dependence and are non-treatment seeking at the time of the study.
  • Be between 18 and 50 years of age, inclusive.
  • Be currently use cocaine. Use must be confirmed by a positive urine test for cocaine metabolites once within the outpatient screening period.
  • Be able to verbalize understanding of the consent form and provide written informed consent.

  • Females must have a negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine. They must also be postmenopausal, have had a hysterectomy, been sterilized, or agree to use one of the following methods of birth control:

    • diaphragm and condom by partner
    • intrauterine device (that does not contain progesterone) and condom by partner
    • sponge and condom by partner
    • complete abstinence from sexual intercourse

Note: Oral contraceptives, Depo-Provera, Norplant, Patch, and intrauterine progesterone contraceptive system are not allowed.

Exclusion Criteria:

  • Please contact site for more information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
0mg
Active Comparator: Lofexidine
Drug: Lofexidine
0.8mg alone and concurrent with IV cocaine infusions of 20 mg and 40 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event and Cardiovascular Response
Time Frame: Daily, up to 9 days
Adverse Events will measured during follow-up at weeks 14-21
Daily, up to 9 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK) Parameter of Cocaine and Benzoylecgonine (BE)
Time Frame: Daily, up to 9 days
Daily, up to 9 days
PK of Lofexidine
Time Frame: Daily, up to 9 days
Daily, up to 9 days
Visual Analog Scale (VAS)
Time Frame: Daily, up to 9 days
Daily, up to 9 days
Brief Substance Abuse Craving Scale (BSCA)
Time Frame: Daily, up to 9 days
Daily, up to 9 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

June 17, 2010

First Submitted That Met QC Criteria

June 22, 2010

First Posted (Estimate)

June 23, 2010

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lofexidine-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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