Interactions Between Intravenous (IV) Cocaine and Lofexidine

Cocaine Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01148992
• Other study ID #: Lofexidine-0001
• Status: Terminated
• Phase: Phase 1
• First received: June 17, 2010
• Last updated: January 10, 2017
• Start date: August 2010
• Est. completion date: March 2011

Study information

• Verified date: August 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Related Disorders
• Cocaine-Related Disorders

Intervention

Drug:
• Lofexidine
0.8mg alone and concurrent with IV cocaine infusions of 20 mg and 40 mg
• Placebo
0mg

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas
United States	California Pacific Medical Center Research Institute	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event and Cardiovascular Response	Adverse Events will measured during follow-up at weeks 14-21	Daily, up to 9 days	Yes
Secondary	Pharmacokinetics (PK) Parameter of Cocaine and Benzoylecgonine (BE)		Daily, up to 9 days	Yes
Secondary	PK of Lofexidine		Daily, up to 9 days	Yes
Secondary	Visual Analog Scale (VAS)		Daily, up to 9 days	Yes
Secondary	Brief Substance Abuse Craving Scale (BSCA)		Daily, up to 9 days	Yes