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

National Institute on Drug Abuse (NIDA)2 sites in 1 country16 target enrollmentAugust 2010

ConditionsCocaine Related Disorders

InterventionsLofexidine Placebo

DrugsLofexidine Placebo

Overview

Phase: Phase 1
Intervention: Lofexidine
Conditions: Cocaine Related Disorders
Sponsor: National Institute on Drug Abuse (NIDA)
Enrollment: 16
Locations: 2
Primary Endpoint: Adverse Event and Cardiovascular Response
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

March 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Institute on Drug Abuse (NIDA)

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Lofexidine

Intervention: Lofexidine

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Adverse Event and Cardiovascular Response

Time Frame: Daily, up to 9 days

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

Secondary Outcomes

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)