Interactions Between Intravenous (IV) Cocaine and Lofexidine

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

Detailed Description
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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.

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

Conditions
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Cocaine Related Disorders

Intervention / Treatment
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* Drug: Lofexidine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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