Interactions Between Intravenous (IV) Cocaine and Lofexidine

Phase 1

Terminated

• Conditions: Cocaine Related Disorders
• Interventions: Drug: Placebo; Drug: Lofexidine

• Registration Number: NCT01148992
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

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

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 Timeline

• Study First Submitted: 2010-06-17
• Study First Submitted QC: 2010-06-22
• Study First Posted: 2010-06-23
• Study Start: 2010-08
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Status Verified: 2016-08
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Lofexidine	Lofexidine	-

Primary Outcome Measures

Name	Time	Method
Adverse Event and Cardiovascular Response	Daily, up to 9 days	Adverse Events will measured during follow-up at weeks 14-21

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

California Pacific Medical Center Research Institute; 🇺🇸 San Francisco, California, United States