Interactions Between Intravenous (IV) Cocaine and Lofexidine

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01148992

Enrollment

Registered

2010-06-23

Start date

2010-08-31

Completion date

2011-03-31

Last updated

2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine Related Disorders

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.

Interventions

DRUGLofexidine

0.8mg alone and concurrent with IV cocaine infusions of 20 mg and 40 mg

DRUGPlacebo

0mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Visual Analog Scale (VAS)	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
PK of Lofexidine	Daily, up to 9 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026